A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00474526
Collaborator
(none)
4,545
63
17
32.1
72.1
2.2
Study Details
Study Description
Brief Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4545 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Study Start Date
:
Mar 1, 2007
Actual Primary Completion Date
:
Sep 1, 2008
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: US1A (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US1B (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US2 (Infant Vaccines Only) Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US3 (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US4A (Infant Vaccines Only) Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US4B (Infant Vaccines Only) Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: US4C (Infant Vaccines Only) Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA1A (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA1B (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA2 (Infant Vaccines Only) Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA3A (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
Biological: DTaP
Other Names:
|
| Experimental: LA3B (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
Biological: DTaP
Other Names:
|
| Experimental: LA4 (Infant Vaccines Only) Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
Biological: DTaP
Other Names:
|
| Experimental: LA5 (MenACWY-CRM + Infant Vaccines) Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA6A (Infant Vaccines Only) Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA6B (Infant Vaccines Only) Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
Biological: MMR-V
Other Names:
|
| Experimental: LA6C (Infant Vaccines Only) Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months |
Biological: Meningococcal ACWY Conjugate Vaccine
Other Names:
Biological: DTaP-IPV-HBV
Other Names:
Biological: Hib
Other Names:
Biological: Rotavirus
Other Names:
Biological: Pneumococcal 7-valent Conjugate Vaccine
Other Names:
Biological: HAV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With hSBA Titer >=1:8 - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
- Geometric Mean hSBA Titers - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
Secondary Outcome Measures
- Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series [7 days after vaccination]
Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series [7 days after vaccination]
Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series [7 days after vaccination]
Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age [7 days after vaccination]
Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series [7 days post vaccination]
Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series [7 days post vaccination]
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
- Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series [7 days post-vaccination]
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series [7 days post-vaccination]
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
- Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series [7 days post-vaccination]
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
- Geometric Mean hSBA Titers Post-infant Series - US Subjects [7 months of age (one month post-infant series)]
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
- Geometric Mean hSBA Titers Post-infant Series - LA Subjects [7 months of age (one month post-infant series)]
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
- Percentage of Subjects With hSBA Titer >=1:8 - US Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
- Percentage of Subjects With hSBA Titer >=1:4 - US Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
- Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
- Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
- Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
- Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
- Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
- Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects [7 months of age (one month post-infant series)]
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
- Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject [12 Months of Age (one month pre-toddler vaccination)]
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
- Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject [12 Months of Age (one month pre-toddler vaccination)]
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
- Persistence Antibodies Geometric Mean Titers - US Subject [12 Months of Age (one month pre-toddler vaccination)]
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
- Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject [12 or 16 Months of Age (one month pre-toddler vaccination)]
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
- Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject [12 or 16 Months of Age (one month pre-toddler vaccination)]
Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
- Persistence Antibodies Geometric Mean Titers - LA Subjects [12 or 16 Months of Age (one month pre-toddler vaccination)]
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
- Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.
- Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.
- Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.
- Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
- Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects [13 or 17 Months of Age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.
- Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects [13 or 17 Months of Age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
- Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects [13 or 17 Months of Age (one month post-toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.
- Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects [13 or 17 Months of Age (one month post-toddler vaccination)]
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
- Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
- Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
- Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
- Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects [13 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F
- Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects [17 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
- Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects [17 months of age (one month post-toddler vaccination)]
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
- Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects [12 or 15 months of age (one month post 1st or 2nd toddler vaccination)]
Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
- Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects [12 or 15 months of age (one month post 1st or 2nd toddler vaccination)]
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Months
to 2 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
Exclusion Criteria:
- Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Growing Up Pediatrics | Bessemer | Alabama | United States | 35022 |
| 2 | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | United States | 03523 |
| 3 | Growing Up Pediatrics | Birmingham | Alabama | United States | 35242 |
| 4 | Premier Health Research Center, LLC | Downey | California | United States | 90241 |
| 5 | Kaiser Permanente Oakland | Oakland | California | United States | 94611 |
| 6 | Kaiser Permanente Med Group - Vaccine Study Ctr | Oakland | California | United States | 94612 |
| 7 | Center for Clinical Trials, LLC | Paramount | California | United States | 90723 |
| 8 | Kaiser Permanente Pleasanton | Pleasanton | California | United States | 94588 |
| 9 | Kaiser Permanente Richmond | Richmond | California | United States | 94801 |
| 10 | Kaiser Permanente San Francisco | San Francisco | California | United States | 94115 |
| 11 | Kaiser Permanente Santa Clara | Santa Clara | California | United States | 95051 |
| 12 | UCLA Center for Vaccine Research | Torrence | California | United States | 90502 |
| 13 | The Children's Hospital | Aurora | Colorado | United States | 80045 |
| 14 | Longmont Medical Research Network | Longmont | Colorado | United States | 80501 |
| 15 | Children's Memorial Hospital | Chicago | Illinois | United States | 60614-3394 |
| 16 | Kentucky Pediatric/Adult Research Inc. | Bardstown | Kentucky | United States | 40004 |
| 17 | Annapolis Pediatrics | Annapolis | Maryland | United States | 21401 |
| 18 | Center for Vaccine Development | Baltimore | Maryland | United States | 21201 |
| 19 | The Pediatric Center | Frederick | Maryland | United States | 21702 |
| 20 | Boston University Medical Center | Boston | Massachusetts | United States | 02118 |
| 21 | Pediatric Associates of Fall River | Fall River | Massachusetts | United States | 02724 |
| 22 | Creighton University | Omaha | Nebraska | United States | 68131 |
| 23 | Children's Physicians Dundee | Omaha | Nebraska | United States | 68132 |
| 24 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 25 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
| 26 | Akron Children's Hospital | Akron | Ohio | United States | 44308 |
| 27 | Louis P. Brine, Jr., MD, Beeghley Medical Park | Boardman | Ohio | United States | 44512 |
| 28 | Senders Pediatric Research at Dr. Senders and Associates | Cleveland | Ohio | United States | 44118 |
| 29 | Carnegie Pediatrics | Carnegie | Pennsylvania | United States | 15106 |
| 30 | Children's Health Care - West | Erie | Pennsylvania | United States | 16505 |
| 31 | UPMC/Community Medicine, Inc. | Greenville | Pennsylvania | United States | 16125 |
| 32 | Family Healthcare Partners | Grove City | Pennsylvania | United States | 16127 |
| 33 | Pennridge Pediatric Associates | Harleyville | Pennsylvania | United States | 19438 |
| 34 | Pediatric Associates of Latrobe | Latrobe | Pennsylvania | United States | 15650 |
| 35 | Pediatric Medical Associates | Norristown | Pennsylvania | United States | 19401 |
| 36 | Squirrel Hill Office | Pittsburgh | Pennsylvania | United States | 15217 |
| 37 | Pediatric Alliance, Greentree Division | Pittsburgh | Pennsylvania | United States | 15220 |
| 38 | South Hills Pediatrics | Pittsburgh | Pennsylvania | United States | 15227 |
| 39 | Pediatric Alliance, Southwestern | Pittsburgh | Pennsylvania | United States | 15236 |
| 40 | Primary Physicians Research, Inc | Pittsburgh | Pennsylvania | United States | 15241 |
| 41 | Pediatrics Medical Associates | Rydal | Pennsylvania | United States | 19046 |
| 42 | Pennridge Pediatric Associates | Sellersville | Pennsylvania | United States | 18960 |
| 43 | Laurel Pediatrics | Uniontown | Pennsylvania | United States | 15401 |
| 44 | CCP - Pittsburgh Pediatrics | Wexford | Pennsylvania | United States | 15090 |
| 45 | Goodlettsville Pediatrics | Madison | Tennessee | United States | 37115-2154 |
| 46 | Research Across America | Dallas | Texas | United States | 75234 |
| 47 | Mercury Pharma Services | Houston | Texas | United States | 77024 |
| 48 | Scott and White Hospital | Temple | Texas | United States | 76508 |
| 49 | Wee Care Pediatrics | Layton | Utah | United States | 84041 |
| 50 | Utah Valley Pediatrics - Timpanogos | Orem | Utah | United States | 84057 |
| 51 | Foothill Family Clinic | Salt Lake City | Utah | United States | 84121 |
| 52 | Copperview Medical Center | South Jordan | Utah | United States | 84095 |
| 53 | Monroe Medical Foundation | Monroe | Wisconsin | United States | 53566 |
| 54 | CEDEPAP Rio IV | Alvear 1439 PB Dpto, rio IV, Cordoba | Cordoba | Argentina | |
| 55 | Hospitales Materno Neonatal, | Castro Barros 650 - Barrio San Martin, Cordoba | Cordoba | Argentina | |
| 56 | Hospital Regional Luis Pasteur, | Mendoza n°2152, Villa Maria, Cordoba, | Cordoba | Argentina | |
| 57 | Buenos Aires, Argentina | Buenos Aires | Argentina | C1406DGI | |
| 58 | CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465, | Cordoba | Argentina | X5000BJH | |
| 59 | Centro Estudios Infect | Scalabrini Ortiz 676, Buenos Aires, Buenos Aires, | Argentina | ||
| 60 | Siloe | Calle 1 #50-51 | Cali | Colombia | 405 |
| 61 | Comfenalco | Calle 6#5-42 | Cali | Colombia | 405 |
| 62 | Hospital C H Trujillo | Calle 72U 28 F-00 | Cali | Colombia | 405 |
| 63 | Corporation Cientifica | Ped Calle 5B5 No.37 BIS-28 | Cali | Colombia | 405 |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis - Vaccines, Novartis Vaccines & Diagnostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00474526
Other Study ID Numbers:
- V59P14
First Posted:
May 17, 2007
Last Update Posted:
Mar 24, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4A (Infant Vaccines Only) | US4B (Infant Vaccines Only) | US4C (Infant Vaccines Only) | LA1A (MenACWY-CRM + Infant Vaccines) | LA1B (MenACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3A (MenACWY-CRM + Infant Vaccines) | LA3B (MenACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6A (Infant Vaccines Only) | LA6B (Infant Vaccines Only) | LA6C (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age. | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age |
| Period Title: Overall Study | |||||||||||||||||
| STARTED | 154 | 166 | 159 | 680 | 76 | 70 | 203 | 151 | 150 | 148 | 151 | 150 | 150 | 1426 | 358 | 170 | 183 |
| COMPLETED | 121 | 120 | 110 | 561 | 8 | 54 | 178 | 145 | 144 | 121 | 141 | 139 | 135 | 1270 | 281 | 152 | 174 |
| NOT COMPLETED | 33 | 46 | 49 | 119 | 68 | 16 | 25 | 6 | 6 | 27 | 10 | 11 | 15 | 156 | 77 | 18 | 9 |
Baseline Characteristics
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4A (Infant Vaccines Only) | US4B (Infant Vaccines Only) | US4C (Infant Vaccines Only) | LA1A (MenACWY-CRM + Infant Vaccines) | LA1B (MenACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3A (MenACWY-CRM + Infant Vaccines) | LA3B (MenACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6A (Infant Vaccines Only) | LA6B (Infant Vaccines Only) | LA6C (Infant Vaccines Only) | TOTAL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age. | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age | Total of all reporting groups |
| Overall Participants | 154 | 166 | 159 | 680 | 76 | 70 | 203 | 151 | 150 | 148 | 151 | 150 | 150 | 1426 | 358 | 170 | 183 | 4545 |
| Age (days) [Mean (Standard Deviation) ] | ||||||||||||||||||
| Mean (Standard Deviation) [days] |
66.1
(7.2)
|
65.8
(6.6)
|
65.7
(6.5)
|
65.0
(6.0)
|
66.1
(6.2)
|
65.0
(6.5)
|
65.9
(6.5)
|
68.0
(7.7)
|
68.6
(8.9)
|
67.8
(8.3)
|
67.0
(7.9)
|
68.4
(8.7)
|
67.5
(8.0)
|
65.0
(9.4)
|
67.7
(9.7)
|
59.5
(6.2)
|
65.0
(7.9)
|
65.7
(8.3)
|
| Sex: Female, Male (Count of Participants) | ||||||||||||||||||
| Female |
68
44.2%
|
72
43.4%
|
71
44.7%
|
340
50%
|
39
51.3%
|
29
41.4%
|
103
50.7%
|
79
52.3%
|
82
54.7%
|
72
48.6%
|
72
47.7%
|
75
50%
|
81
54%
|
682
47.8%
|
178
49.7%
|
89
52.4%
|
91
49.7%
|
2223
48.9%
|
| Male |
86
55.8%
|
94
56.6%
|
88
55.3%
|
340
50%
|
37
48.7%
|
41
58.6%
|
100
49.3%
|
72
47.7%
|
68
45.3%
|
76
51.4%
|
79
52.3%
|
75
50%
|
69
46%
|
744
52.2%
|
180
50.3%
|
81
47.6%
|
92
50.3%
|
2322
51.1%
|
Outcome Measures
| Title | Percentage of Subjects With hSBA Titer >=1:8 - US Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population Per protocol was defined as subjects who: received all the relevant doses of vaccine correctly provided evaluable serum samples at the relevant time points had no major protocol deviation as defined prior to database lock |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 86 | 74 |
| A (84, 74) |
94
|
72
|
| C (86, 73) |
98
|
90
|
| W (85, 73) |
100
|
58
|
| Y (84, 68) |
100
|
56
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed. |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines ) | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4 (Infant Vaccines Only ) | LA1 (MenACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3 (MenACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6 (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups. |
| Measure Participants | 153 | 165 | 318 | 159 | 677 | 345 | 301 | 148 | 301 | 150 | 1424 | 709 |
| Erythema (mm) - Any |
10
|
17
|
27
|
23
|
66
|
54
|
86
|
62
|
86
|
65
|
542
|
273
|
| Erythema (mm) - Severe |
0
|
0
|
0
|
2
|
0
|
4
|
0
|
0
|
1
|
1
|
1
|
4
|
| Induration (mm) - Any |
10
|
14
|
24
|
25
|
61
|
44
|
74
|
56
|
72
|
53
|
249
|
126
|
| Induration (mm) - Severe |
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
2
|
0
|
| Tenderness - Any |
64
|
76
|
140
|
69
|
324
|
161
|
154
|
96
|
170
|
95
|
916
|
501
|
| Tenderness - Severe |
3
|
4
|
7
|
6
|
25
|
19
|
30
|
19
|
22
|
20
|
92
|
74
|
| Body Temp. ( >= 38° C ) |
13
|
6
|
19
|
7
|
32
|
21
|
15
|
12
|
18
|
5
|
211
|
97
|
| Change in Eating Habits - Any |
42
|
46
|
88
|
34
|
171
|
96
|
37
|
30
|
44
|
16
|
250
|
127
|
| Change in Eating Habits - Severe |
1
|
1
|
2
|
1
|
8
|
2
|
2
|
0
|
0
|
1
|
6
|
4
|
| Diarrhea - Any |
24
|
23
|
47
|
17
|
107
|
46
|
42
|
20
|
44
|
22
|
222
|
96
|
| Diarrhea - Severe |
2
|
0
|
2
|
1
|
3
|
1
|
1
|
0
|
1
|
0
|
2
|
2
|
| Irritability - Any |
82
|
107
|
189
|
96
|
419
|
211
|
121
|
62
|
99
|
59
|
508
|
240
|
| Irritability - Severe |
6
|
2
|
8
|
4
|
24
|
12
|
7
|
2
|
4
|
2
|
22
|
2
|
| Persistent Crying - Any |
43
|
74
|
117
|
49
|
252
|
125
|
95
|
53
|
87
|
43
|
479
|
258
|
| Persistent Crying - Severe |
1
|
2
|
3
|
5
|
11
|
8
|
5
|
3
|
11
|
8
|
29
|
21
|
| Rash - Any |
6
|
9
|
15
|
5
|
16
|
11
|
11
|
6
|
12
|
4
|
98
|
55
|
| Rash - Severe |
3
|
4
|
7
|
3
|
4
|
3
|
7
|
2
|
4
|
1
|
54
|
26
|
| Sleepiness - Any |
83
|
104
|
187
|
76
|
354
|
173
|
106
|
53
|
93
|
52
|
727
|
381
|
| Sleepiness - Severe |
2
|
3
|
5
|
0
|
14
|
3
|
8
|
2
|
6
|
4
|
21
|
14
|
| Vomiting - Any |
15
|
18
|
33
|
14
|
67
|
36
|
25
|
9
|
29
|
17
|
215
|
100
|
| Vomiting - Severe |
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
2
|
1
|
| Analgesic / Antipyretic medication used |
105
|
120
|
225
|
110
|
447
|
223
|
155
|
75
|
159
|
80
|
996
|
510
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age. |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4 (Infant Vaccines Only) | LA3 (MenACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6 (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups. |
| Measure Participants | 141 | 150 | 291 | 151 | 645 | 325 | 301 | 150 | 1424 | 709 |
| Erythema (mm) - Any |
14
|
19
|
33
|
35
|
75
|
60
|
92
|
45
|
583
|
311
|
| Erythema (mm) - Severe |
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
| Induration (mm) - Any |
16
|
16
|
32
|
27
|
45
|
48
|
73
|
36
|
194
|
126
|
| Induration (mm) - Severe |
1
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
| Tenderness - Any |
59
|
59
|
118
|
56
|
230
|
137
|
115
|
59
|
726
|
401
|
| Tenderness - Severe |
1
|
0
|
1
|
2
|
13
|
11
|
13
|
5
|
49
|
45
|
| Body Temp. ( >= 38° C ) |
17
|
6
|
23
|
15
|
49
|
28
|
23
|
13
|
223
|
122
|
| Change in Eating Habits - Any |
25
|
21
|
46
|
20
|
122
|
64
|
28
|
12
|
160
|
90
|
| Change in Eating Habits - Severe |
0
|
0
|
0
|
0
|
3
|
0
|
3
|
0
|
6
|
5
|
| Diarrhea - Any |
16
|
10
|
26
|
11
|
53
|
35
|
28
|
14
|
149
|
90
|
| Diarrhea - Severe |
0
|
1
|
1
|
1
|
1
|
2
|
1
|
0
|
4
|
1
|
| Irritability - Any |
83
|
80
|
163
|
83
|
342
|
182
|
82
|
41
|
414
|
209
|
| Irritability - Severe |
2
|
0
|
2
|
3
|
14
|
9
|
3
|
0
|
13
|
5
|
| Persistent Crying - Any |
42
|
41
|
83
|
34
|
178
|
107
|
42
|
22
|
294
|
187
|
| Persistent Crying - Severe |
0
|
0
|
0
|
0
|
5
|
4
|
4
|
1
|
14
|
10
|
| Rash - Any |
3
|
5
|
8
|
4
|
24
|
13
|
13
|
2
|
97
|
46
|
| Rash - Severe |
3
|
1
|
4
|
1
|
6
|
4
|
5
|
1
|
52
|
29
|
| Sleepiness - Any |
69
|
56
|
125
|
47
|
238
|
131
|
62
|
26
|
485
|
237
|
| Sleepiness - Severe |
0
|
0
|
0
|
1
|
3
|
2
|
4
|
1
|
13
|
7
|
| Vomiting - Any |
8
|
9
|
17
|
7
|
49
|
27
|
20
|
10
|
136
|
75
|
| Vomiting - Severe |
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
0
|
| Analgesic / Antipyretic medication used |
94
|
91
|
185
|
96
|
385
|
201
|
131
|
61
|
857
|
430
|
| Title | Geometric Mean hSBA Titers - US Subjects |
|---|---|
| Description | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 86 | 74 |
| A Pre-vaccination (84, 74) |
2.51
|
2.14
|
| A Post-vaccination (84, 74) |
77
|
17
|
| C Pre-vaccination (86, 73) |
7.72
|
2.26
|
| C Post-vaccination (86, 73) |
227
|
35
|
| W Pre-vaccination (85, 73) |
14
|
2.21
|
| W Post-vaccination (85, 73) |
416
|
11
|
| Y Pre-vaccination (84, 68) |
11
|
2.14
|
| Y Post-vaccination (84, 68) |
395
|
10
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.53 | |
| Confidence Interval |
(2-Sided) 95% 3.04 to 6.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | A (Post-vaccination GMT; group ratio US1A:US2) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 6.39 | |
| Confidence Interval |
(2-Sided) 95% 4.16 to 9.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | C (Post-vaccination GMT; group ratio US1A:US2) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 37 | |
| Confidence Interval |
(2-Sided) 95% 24 to 58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | W (Post-vaccination GMT; group ratio US1A:US2) | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0. Ratio of GMTs | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 38 | |
| Confidence Interval |
(2-Sided) 95% 24 to 60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Y (Post-vaccination GMT; group ratio US1A:US2) | |
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4 (Infant Vaccines Only) | LA1 (MenACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3 (MenACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6 (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups. |
| Measure Participants | 138 | 145 | 283 | 143 | 627 | 311 | 297 | 131 | 290 | 147 | 1357 | 679 |
| Erythema (mm) - Any |
16
|
18
|
34
|
28
|
92
|
67
|
69
|
27
|
64
|
38
|
485
|
273
|
| Erythema (mm) - Severe |
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
1
|
| Induration (mm) - Any |
15
|
15
|
30
|
29
|
59
|
53
|
54
|
25
|
64
|
32
|
125
|
73
|
| Induration (mm) - Severe |
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
| Tenderness - Any |
37
|
45
|
82
|
45
|
189
|
92
|
92
|
40
|
78
|
50
|
504
|
306
|
| Tenderness - Severe |
0
|
0
|
0
|
1
|
1
|
7
|
6
|
2
|
2
|
1
|
21
|
14
|
| Body Temp. ( >= 38° C ) |
4
|
9
|
13
|
14
|
33
|
20
|
13
|
10
|
26
|
14
|
164
|
101
|
| Change in Eating Habits - Any |
19
|
22
|
41
|
18
|
94
|
39
|
25
|
11
|
23
|
9
|
126
|
66
|
| Change in Eating Habits - Severe |
0
|
0
|
0
|
1
|
3
|
2
|
1
|
1
|
1
|
0
|
5
|
3
|
| Diarrhea - Any |
13
|
9
|
22
|
9
|
41
|
26
|
17
|
8
|
12
|
11
|
97
|
58
|
| Diarrhea - Severe |
0
|
0
|
0
|
0
|
2
|
1
|
1
|
1
|
0
|
0
|
2
|
3
|
| Irritability - Any |
58
|
73
|
131
|
70
|
285
|
157
|
57
|
29
|
62
|
28
|
311
|
164
|
| Irritability - Severe |
1
|
1
|
2
|
0
|
4
|
6
|
0
|
1
|
2
|
0
|
5
|
2
|
| Persistent Crying - Any |
28
|
26
|
54
|
24
|
135
|
74
|
28
|
15
|
27
|
12
|
181
|
118
|
| Persistent Crying - Severe |
0
|
0
|
0
|
0
|
4
|
4
|
2
|
2
|
0
|
0
|
11
|
2
|
| Rash - Any |
2
|
9
|
11
|
4
|
14
|
8
|
8
|
1
|
6
|
1
|
62
|
29
|
| Rash - Severe |
1
|
4
|
5
|
3
|
2
|
1
|
5
|
0
|
3
|
1
|
29
|
10
|
| Sleepiness - Any |
37
|
41
|
78
|
39
|
179
|
91
|
38
|
15
|
45
|
17
|
317
|
164
|
| Sleepiness - Severe |
0
|
0
|
0
|
0
|
6
|
1
|
1
|
0
|
1
|
0
|
6
|
3
|
| Vomiting - Any |
6
|
6
|
12
|
9
|
31
|
20
|
16
|
9
|
11
|
12
|
104
|
52
|
| Vomiting - Severe |
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
0
|
1
|
1
|
| Analgesic / Antipyretic medication used |
75
|
82
|
157
|
96
|
349
|
178
|
93
|
38
|
90
|
51
|
592
|
342
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age |
|---|---|
| Description | Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. |
| Time Frame | 7 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US1A + US3 (MenACWY-CRM + Infant Vaccines) | US2 + US4A (Infant Vaccines Only) | US3 (MenACWY-CRM + Infant Vaccines) | US4B + US4C (Infant Vaccines Only) | LA1A (MenACWY-CRM + Infant Vaccines) | LA1B (MenACWY-CRM + Infant Vaccines) | LA2 + LA4 + LA6A (Infant Vaccines Only) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6B + LA6C (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | Groups Infant Vaccines only (US4B and US4C) pooled. Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C). | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. | Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | Groups Infant Vaccines only LA6B and LA6C pooled. Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C). |
| Measure Participants | 122 | 124 | 704 | 137 | 582 | 261 | 145 | 143 | 564 | 1275 | 349 |
| Erythema (mm) - Any |
11
|
16
|
81
|
18
|
70
|
49
|
36
|
33
|
166
|
309
|
67
|
| Erythema (mm) - Severe |
0
|
0
|
2
|
1
|
2
|
1
|
0
|
1
|
2
|
0
|
0
|
| Induration (mm) - Any |
10
|
13
|
44
|
12
|
34
|
39
|
32
|
28
|
72
|
84
|
43
|
| Induration (mm) - Severe |
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
| Tenderness - Any |
28
|
31
|
177
|
38
|
149
|
75
|
35
|
32
|
184
|
392
|
100
|
| Tenderness - Severe |
0
|
0
|
2
|
0
|
2
|
1
|
6
|
2
|
2
|
8
|
3
|
| Body Temp. ( >= 38° C ) |
14
|
10
|
49
|
12
|
35
|
20
|
16
|
12
|
84
|
188
|
40
|
| Change in Eating Habits - Any |
21
|
17
|
101
|
20
|
80
|
29
|
10
|
11
|
56
|
138
|
46
|
| Change in Eating Habits - Severe |
1
|
2
|
7
|
1
|
6
|
1
|
1
|
0
|
4
|
5
|
0
|
| Diarrhea - Any |
5
|
14
|
61
|
16
|
56
|
14
|
9
|
10
|
51
|
123
|
37
|
| Diarrhea - Severe |
0
|
0
|
4
|
1
|
4
|
1
|
0
|
0
|
5
|
7
|
1
|
| Irritability - Any |
53
|
53
|
271
|
62
|
218
|
103
|
29
|
23
|
130
|
289
|
74
|
| Irritability - Severe |
2
|
2
|
8
|
4
|
6
|
1
|
1
|
2
|
5
|
3
|
0
|
| Persistent Crying - Any |
21
|
21
|
120
|
24
|
99
|
55
|
7
|
12
|
52
|
134
|
28
|
| Persistent Crying - Severe |
0
|
0
|
6
|
1
|
6
|
1
|
0
|
1
|
0
|
2
|
0
|
| Rash - Any |
8
|
4
|
31
|
5
|
23
|
12
|
3
|
1
|
20
|
65
|
17
|
| Rash - Severe |
1
|
1
|
3
|
3
|
2
|
3
|
2
|
0
|
8
|
36
|
10
|
| Sleepiness - Any |
38
|
29
|
149
|
22
|
111
|
50
|
18
|
15
|
81
|
211
|
53
|
| Sleepiness - Severe |
0
|
1
|
3
|
1
|
3
|
3
|
0
|
0
|
1
|
3
|
2
|
| Vomiting - Any |
6
|
4
|
27
|
8
|
21
|
11
|
3
|
5
|
35
|
82
|
12
|
| Vomiting - Severe |
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
3
|
4
|
0
|
| Analgesic / Antipyretic medication used |
60
|
56
|
320
|
78
|
260
|
120
|
48
|
43
|
204
|
406
|
87
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series |
|---|---|
| Description | Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. |
| Time Frame | 7 days post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. |
| Arm/Group Title | US1B (MenACWY-CRM + Infant Vaccines) | US1A + US3 (MenACWY-CRM + Infant Vaccines) | US2 + US4A (Infant Vaccines Only) | US4B (Infant Vaccines Only) | US4C (Infant Vaccines Only) | LA1A (MenACWY-CRM + Infant Vaccines) | LA1B (MenACWY-CRM + Infant Vaccines) | LA2 + LA4 + LA6A (Infant Vaccines Only) | LA3A (MenACWY-CRM + Infant Vaccines) | LA3B (MenACWY-CRM + Infant Vaccines) | LA5 (MenACWY-CRM + Infant Vaccines) | LA6B (Infant Vaccines Only) | LA6C (Infant Vaccines Only) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age. | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. | Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age |
| Measure Participants | 120 | 704 | 136 | 59 | 179 | 145 | 143 | 564 | 142 | 137 | 1275 | 160 | 175 |
| Erythema (mm) - Any |
7
|
81
|
18
|
9
|
28
|
36
|
17
|
166
|
36
|
19
|
309
|
24
|
52
|
| Erythema (mm) - Severe |
0
|
2
|
1
|
0
|
1
|
0
|
1
|
2
|
1
|
1
|
0
|
0
|
7
|
| Induration (mm) - Any |
1
|
44
|
12
|
3
|
14
|
32
|
9
|
72
|
33
|
16
|
84
|
5
|
35
|
| Induration (mm) - Severe |
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
5
|
| Tenderness - Any |
16
|
177
|
38
|
10
|
38
|
35
|
21
|
184
|
36
|
18
|
392
|
34
|
45
|
| Tenderness - Severe |
0
|
2
|
0
|
1
|
1
|
6
|
1
|
2
|
2
|
2
|
8
|
0
|
5
|
| Body Temp. ( >= 38° C ) |
5
|
49
|
12
|
0
|
5
|
16
|
5
|
84
|
4
|
2
|
188
|
7
|
8
|
| Change in Eating Habits - Any |
9
|
101
|
20
|
5
|
14
|
10
|
4
|
56
|
6
|
6
|
138
|
9
|
17
|
| Change in Eating Habits - Severe |
0
|
7
|
1
|
0
|
1
|
1
|
1
|
4
|
1
|
0
|
5
|
0
|
0
|
| Diarrhea - Any |
8
|
61
|
16
|
5
|
13
|
9
|
4
|
51
|
8
|
2
|
123
|
6
|
12
|
| Diarrhea - Severe |
0
|
4
|
1
|
2
|
1
|
0
|
0
|
5
|
0
|
1
|
7
|
0
|
0
|
| Irritability - Any |
39
|
271
|
62
|
17
|
52
|
29
|
10
|
130
|
13
|
9
|
289
|
25
|
28
|
| Irritability - Severe |
1
|
8
|
4
|
1
|
1
|
1
|
0
|
5
|
0
|
0
|
3
|
1
|
0
|
| Persistent Crying - Any |
16
|
120
|
24
|
10
|
17
|
7
|
5
|
52
|
4
|
5
|
134
|
9
|
15
|
| Persistent Crying - Severe |
0
|
6
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
| Rash - Any |
1
|
31
|
5
|
2
|
5
|
3
|
1
|
20
|
2
|
1
|
65
|
2
|
2
|
| Rash - Severe |
0
|
3
|
3
|
0
|
2
|
2
|
1
|
8
|
2
|
0
|
36
|
0
|
1
|
| Sleepiness - Any |
25
|
149
|
22
|
6
|
21
|
18
|
3
|
81
|
6
|
7
|
211
|
14
|
20
|
| Sleepiness - Severe |
1
|
3
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
3
|
1
|
1
|
| Vomiting - Any |
2
|
27
|
8
|
2
|
6
|
3
|
0
|
35
|
1
|
3
|
82
|
4
|
3
|
| Vomiting - Severe |
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
4
|
0
|
0
|
| Analgesic / Antipyretic medication used |
37
|
320
|
77
|
16
|
45
|
48
|
15
|
204
|
20
|
8
|
406
|
14
|
34
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series |
|---|---|
| Description | Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age. |
| Time Frame | 7 days post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis. |
| Arm/Group Title | US2 + US4A (Infant Vaccines Only) | US4B (Infant Vaccines Only) | LA2 + LA4 + LA6A (Infant Vaccines Only) | LA6B (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age. | Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age. |
| Measure Participants | 120 | 55 | 539 | 153 |
| Erythema (mm) - Any |
14
|
6
|
143
|
28
|
| Erythema (mm) - Severe |
0
|
1
|
2
|
0
|
| Induration (mm) - Any |
10
|
2
|
51
|
2
|
| Induration (mm) - Severe |
0
|
1
|
1
|
0
|
| Tenderness - Any |
19
|
16
|
128
|
33
|
| Tenderness - Severe |
0
|
0
|
5
|
1
|
| Body Temp. ( >= 38° C ) |
5
|
1
|
30
|
15
|
| Change in Eating Habits - Any |
7
|
2
|
18
|
11
|
| Change in Eating Habits - Severe |
0
|
0
|
0
|
1
|
| Diarrhea - Any |
4
|
3
|
28
|
9
|
| Diarrhea - Severe |
1
|
0
|
1
|
0
|
| Irritability - Any |
31
|
22
|
71
|
32
|
| Irritability - Severe |
0
|
0
|
2
|
1
|
| Persistent Crying - Any |
9
|
10
|
37
|
6
|
| Persistent Crying - Severe |
0
|
0
|
3
|
2
|
| Rash - Any |
4
|
1
|
9
|
3
|
| Rash - Severe |
0
|
0
|
4
|
3
|
| Sleepiness - Any |
12
|
8
|
36
|
12
|
| Sleepiness - Severe |
0
|
0
|
1
|
2
|
| Vomiting - Any |
5
|
2
|
12
|
7
|
| Vomiting - Severe |
0
|
0
|
0
|
0
|
| Analgesic / Antipyretic medication used |
40
|
14
|
85
|
21
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. |
| Time Frame | 7 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. |
| Arm/Group Title | US1 + US3 (Men ACWY-CRM + Infant Vaccines) | US2 + US4 (Infant Vaccines Only) | LA3 + LA5 (Men ACWY-CRM + Infant Vaccines) | LA4 + LA6 (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B). | Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received: either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C). | Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled. LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were: Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A) Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B). Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5). | Groups Infant Vaccines only (LA4 and LA6) pooled. LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either: One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4). Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C). |
| Measure Participants | 989 | 503 | 1724 | 859 |
| Erythema (mm) - Any |
93
|
77
|
628
|
338
|
| Erythema (mm) - Severe |
0
|
6
|
2
|
5
|
| Induration (mm) - Any |
85
|
69
|
321
|
179
|
| Induration (mm) - Severe |
0
|
1
|
2
|
0
|
| Tenderness - Any |
464
|
230
|
1086
|
596
|
| Tenderness - Severe |
32
|
25
|
114
|
94
|
| Body Temp. ( >= 38° C ) |
51
|
28
|
229
|
102
|
| Change in Eating Habits - Any |
259
|
130
|
294
|
143
|
| Change in Eating Habits - Severe |
10
|
3
|
6
|
5
|
| Diarrhea - Any |
154
|
63
|
266
|
118
|
| Diarrhea - Severe |
5
|
2
|
3
|
2
|
| Irritability - Any |
608
|
307
|
607
|
299
|
| Irritability - Severe |
32
|
16
|
26
|
4
|
| Persistent Crying - Any |
369
|
174
|
566
|
301
|
| Persistent Crying - Severe |
14
|
13
|
40
|
29
|
| Rash - Any |
31
|
16
|
110
|
59
|
| Rash - Severe |
11
|
6
|
58
|
27
|
| Sleepiness - Any |
541
|
249
|
820
|
433
|
| Sleepiness - Severe |
19
|
3
|
27
|
18
|
| Vomiting - Any |
100
|
50
|
244
|
117
|
| Vomiting - Severe |
0
|
1
|
3
|
2
|
| Analgesic / Antipyretic medication used |
672
|
333
|
1155
|
590
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. |
| Time Frame | 7 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis. |
| Arm/Group Title | US1+US3 (Men ACWY-CRM + Infant Vaccines) | US2+US4 (Infant Vaccines Only) | LA3+LA5 (Men ACWY-CRM + Infant Vaccines) | LA4+LA6 (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B). | Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C). | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were: Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A) Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B). Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5). | Groups Infant Vaccines only (LA4 and LA6) pooled. LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either: One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4). Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C). |
| Measure Participants | 936 | 476 | 1672 | 824 |
| Erythema (mm) - Any |
108
|
95
|
675
|
356
|
| Erythema (mm) - Severe |
0
|
2
|
0
|
0
|
| Induration (mm) - Any |
77
|
75
|
267
|
162
|
| Induration (mm) - Severe |
1
|
3
|
0
|
0
|
| Tenderness - Any |
348
|
193
|
841
|
460
|
| Tenderness - Severe |
14
|
13
|
62
|
50
|
| Body Temp. ( >= 38° C ) |
72
|
43
|
246
|
135
|
| Change in Eating Habits - Any |
168
|
84
|
188
|
102
|
| Change in Eating Habits - Severe |
3
|
0
|
9
|
5
|
| Diarrhea - Any |
79
|
46
|
177
|
104
|
| Diarrhea - Severe |
2
|
3
|
5
|
1
|
| Irritability - Any |
505
|
265
|
496
|
250
|
| Irritability - Severe |
16
|
12
|
16
|
5
|
| Persistent Crying - Any |
261
|
141
|
336
|
209
|
| Persistent Crying - Severe |
5
|
4
|
18
|
11
|
| Rash - Any |
32
|
17
|
110
|
48
|
| Rash - Severe |
10
|
5
|
57
|
30
|
| Sleepiness - Any |
363
|
178
|
547
|
263
|
| Sleepiness - Severe |
3
|
3
|
17
|
8
|
| Vomiting - Any |
66
|
34
|
156
|
85
|
| Vomiting - Severe |
0
|
1
|
4
|
0
|
| Analgesic / Antipyretic medication used |
570
|
297
|
988
|
491
|
| Title | Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series |
|---|---|
| Description | Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. |
| Time Frame | 7 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis. |
| Arm/Group Title | US1+US3 (Men ACWY-CRM + Infant Vaccines) | US2+US4 (Infant Vaccines Only) | LA3+LA5 (Men ACWY-CRM + Infant Vaccines) | LA4+LA6 (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B). | Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C). | Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were: Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A) Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B). Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5). | Groups Infant Vaccines only (LA4 and LA6) pooled. LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either: One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4). Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C). |
| Measure Participants | 910 | 454 | 1646 | 826 |
| Erythema (mm) - Any |
126
|
95
|
549
|
311
|
| Erythema (mm) - Severe |
0
|
2
|
2
|
1
|
| Induration (mm) - Any |
89
|
82
|
189
|
105
|
| Induration (mm) - Severe |
0
|
3
|
1
|
0
|
| Tenderness - Any |
271
|
137
|
582
|
356
|
| Tenderness - Severe |
1
|
8
|
23
|
15
|
| Body Temp. ( >= 38° C ) |
46
|
34
|
190
|
115
|
| Change in Eating Habits - Any |
135
|
57
|
149
|
75
|
| Change in Eating Habits - Severe |
3
|
3
|
6
|
3
|
| Diarrhea - Any |
63
|
35
|
109
|
69
|
| Diarrhea - Severe |
2
|
1
|
2
|
3
|
| Irritability - Any |
416
|
227
|
373
|
192
|
| Irritability - Severe |
6
|
6
|
7
|
2
|
| Persistent Crying - Any |
189
|
98
|
208
|
130
|
| Persistent Crying - Severe |
4
|
4
|
11
|
2
|
| Rash - Any |
25
|
12
|
68
|
30
|
| Rash - Severe |
7
|
4
|
32
|
11
|
| Sleepiness - Any |
257
|
130
|
362
|
181
|
| Sleepiness - Severe |
6
|
1
|
7
|
3
|
| Vomiting - Any |
43
|
29
|
115
|
64
|
| Vomiting - Severe |
0
|
1
|
2
|
1
|
| Analgesic / Antipyretic medication used |
506
|
274
|
682
|
393
|
| Title | Geometric Mean hSBA Titers Post-infant Series - US Subjects |
|---|---|
| Description | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 212 | 90 |
| A (Pre-vaccination GMT; N= 177, 65) |
2.11
|
2.1
|
| A (Post-vaccination GMT; N= 212, 80) |
13
|
2.03
|
| C (Pre-vaccination GMT; N= 168, 64) |
2.48
|
2.17
|
| C (Post-vaccination GMT; N= 204, 84) |
108
|
2.12
|
| W (Pre-vaccination GMT; N= 165, 66) |
3.07
|
2.71
|
| W (Post-vaccination GMT; N=197, 90) |
100
|
2.08
|
| Y (Pre-vaccination GMT; N=150, 62 ) |
2.53
|
2.13
|
| Y (Post-vaccination GMT; N=182, 84) |
73
|
2.03
|
| Title | Geometric Mean hSBA Titers Post-infant Series - LA Subjects |
|---|---|
| Description | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population |
| Arm/Group Title | LA1 (MenACWY-CRM + Infant Vaccines) | LA3 (MenACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. |
| Measure Participants | 277 | 272 |
| A (Pre-vaccination GMT; N= 272, 271) |
2.09
|
2.03
|
| A (Post-vaccination GMT; N= 277, 268) |
31
|
43
|
| C (Pre-vaccination GMT; N= 273,272) |
2.32
|
2.34
|
| C (Post-vaccination GMT; N= 277, 272) |
155
|
150
|
| W (Pre-vaccination GMT; N= 263, 261) |
2.9
|
2.54
|
| W (Post-vaccination GMT; N=271,264) |
259
|
182
|
| Y (Pre-vaccination GMT; N=258, 260) |
2.35
|
2.26
|
| Y (Post-vaccination GMT; N=272,263) |
159
|
125
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup A (Post-vaccination GMT; group ratio LA1:LA3) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMT |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 95% 0.55 to 0.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup C (Post-vaccination GMT; group ratio LA1:LA3) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup W (Post-vaccination GMT; group ratio LA1:LA3) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.42 | |
| Confidence Interval |
(2-Sided) 95% 1.18 to 1.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 1.02 to 1.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With hSBA Titer >=1:8 - US Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Population |
| Arm/Group Title | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 212 | 90 |
| A (Pre-vaccination GMT; N= 177, 65) |
2
|
3
|
| A (Post-vaccination GMT; N= 212, 80) |
67
|
1
|
| C (Pre-vaccination GMT; N= 168, 64) |
7
|
5
|
| C (Post-vaccination GMT; N= 204, 84) |
97
|
1
|
| W (Pre-vaccination GMT; N= 165, 66) |
17
|
11
|
| W (Post-vaccination GMT; N=197, 90) |
96
|
2
|
| Y (Pre-vaccination GMT; N=150, 62 ) |
5
|
3
|
| Y (Post-vaccination GMT; N=182, 84) |
96
|
0
|
| Title | Percentage of Subjects With hSBA Titer >=1:4 - US Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Population |
| Arm/Group Title | US1 (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 212 | 90 |
| A (Pre-vaccination GMT; N= 177, 65) |
2
|
3
|
| A (Post-vaccination GMT; N= 212, 80) |
71
|
1
|
| C (Pre-vaccination GMT; N= 168, 64) |
10
|
5
|
| C (Post-vaccination GMT; N= 204, 84) |
99
|
2
|
| W (Pre-vaccination GMT; N= 165, 66) |
22
|
15
|
| W (Post-vaccination GMT; N=197, 90) |
99
|
2
|
| Y (Pre-vaccination GMT; N=150, 62 ) |
17
|
5
|
| Y (Post-vaccination GMT; N=182, 84) |
98
|
1
|
| Title | Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population |
| Arm/Group Title | LA1 (MenACWY-CRM + Infant Vaccines) | LA3 (MenACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. |
| Measure Participants | 277 | 272 |
| A (Pre-vaccination hSBA titer ≥1:8; N= 272, 271) |
1
|
0
|
| A (Post-vaccination hSBA titer ≥1:8; N= 277, 268) |
74
|
89
|
| C (Pre-vaccination hSBA titer ≥1:8; N= 273,272) |
4
|
4
|
| C (Post-vaccination hSBA titer ≥1:8; N= 277, 272) |
94
|
97
|
| W (Pre-vaccination hSBA titer ≥1:8; N= 263, 261) |
16
|
10
|
| W (Post-vaccination hSBA titer ≥1:8; N=271,264) |
99
|
98
|
| Y (Pre-vaccination hSBA titer ≥1:8; N=258, 260) |
5
|
3
|
| Y (Post-vaccination hSBA titer ≥1:8; N=272,263) |
97
|
98
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup A (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage (hSBA titers >=8) difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -21.2 to -8.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup C (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage (hSBA titers >=8) difference |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -7 to 0.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup W (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage (hSBA titers >=8) difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -1.3 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Serogroup Y (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage (hSBA titers >=8) difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population |
| Arm/Group Title | LA1 (MenACWY-CRM + Infant Vaccines) | LA3 (MenACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. |
| Measure Participants | 277 | 272 |
| A (Pre-vaccination hSBA titer ≥1:4; N= 272, 271) |
2
|
1
|
| A (Post-vaccination hSBA titer ≥1:4; N= 277, 268) |
78
|
91
|
| C (Pre-vaccination hSBA titer ≥1:4; N= 273,272) |
10
|
10
|
| C (Post-vaccination hSBA titer ≥1:4; N= 277, 272) |
96
|
98
|
| W (Pre-vaccination hSBA titer ≥1:4; N= 263, 261) |
17
|
13
|
| W (Post-vaccination hSBA titer ≥1:4; N=271,264) |
100
|
99
|
| Y (Pre-vaccination hSBA titer ≥1:4; N=258, 260) |
11
|
8
|
| Y (Post-vaccination hSBA titer ≥1:4; N=272,263) |
98
|
99
|
| Title | Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | US1 (Men ACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. |
| Measure Participants | 214 | 102 |
| Diphtheria (214, 102) |
2.52
|
2.88
|
| Tetanus (214, 102) |
2.5
|
2.31
|
| PT (174, 83) |
54
|
54
|
| FHA (174, 83) |
118
|
114
|
| Pertactin (174, 83) |
114
|
110
|
| Polio Type 1 (176, 98) |
422
|
441
|
| Polio Type 2 (175, 98) |
348
|
290
|
| Polio Type 3 (176, 98) |
733
|
635
|
| Hepatitis B (N=148, N=98) |
1863
|
2112
|
| Hib (N=213, N=101) |
4.64
|
3.56
|
| PnC 4 (N=181, N=102) |
1.67
|
2
|
| PnC 6B (N=181, N=102) |
1.94
|
2.55
|
| PnC 9V (N=181, N=102) |
1.83
|
2.15
|
| PnC 14 (N=181, N=102) |
6.97
|
6.79
|
| PnC 18C (N=181, N=102) |
1.96
|
2.54
|
| PnC 19F (N=181, N=102) |
2.24
|
2.73
|
| PnC 23F (N=181, N=102) |
1.71
|
2.15
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Tetanus (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.08 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 1.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (Post-vaccination GMT; group ratio US1:US2 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 1 (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 2 (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.2 | |
| Confidence Interval |
(2-Sided) 95% 0.93 to 1.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 3 (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hepatitis B (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.88 | |
| Confidence Interval |
() 95% 0.65 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | HIb (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.31 | |
| Confidence Interval |
(2-Sided) 95% 0.97 to 1.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.76 | |
| Confidence Interval |
(2-Sided) 95% 0.56 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.85 | |
| Confidence Interval |
() 95% 0.7 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Post-vaccination GMT; group ratio US1:US2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | US1 (Men ACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. |
| Measure Participants | 214 | 102 |
| Diphtheria (≥ 0.1 IU/mL) (214, 102) |
100
|
100
|
| Tetanus (≥ 0.1 IU/mL) (214, 102) |
100
|
100
|
| PT(≥ 4-fold rise) (174, 83) |
87
|
86
|
| FHA (≥ 4-fold rise) (174, 83) |
85
|
80
|
| Pertactin (≥ 4-fold rise) (174, 83) |
76
|
78
|
| Polio Type 1 (≥1:8) (176, 98) |
99
|
100
|
| Polio Type 2 (≥1:8) (176, 98) |
100
|
100
|
| Polio Type 3 (≥1:8)(175, 98) |
99
|
100
|
| Hepatitis B (≥10 mIU/mL) (N=148, N=98) |
99
|
100
|
| Hib (≥ 0.15 μg/mL) (N=213, N=101) |
99
|
100
|
| Hib (≥1.0 μg/mL) (N=213, N=101) |
89
|
84
|
| PnC 4 (≥ 0.35 μg/mL) (N=181, N=102) |
98
|
100
|
| PnC 6B (≥ 0.35 μg/mL) (N=181, N=102) |
88
|
96
|
| PnC 9V (≥ 0.35 μg/mL) (N=181, N=102) |
98
|
98
|
| PnC 14 (≥ 0.35 μg/mL) (N=181, N=102) |
100
|
99
|
| PnC 18C (≥ 0.35 μg/mL) (N=181, N=102) |
97
|
100
|
| PnC 19F (≥ 0.35 μg/mL) (N=181, N=102) |
99
|
100
|
| PnC 23F (≥ 0.35 μg/mL) (N=181, N=102) |
92
|
94
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -3 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Tetanus (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -7 to 12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 6 | |
| Confidence Interval |
(2-Sided) 95% -4 to 17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -12 to 10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 5 | |
| Confidence Interval |
(2-Sided) 95% -3 to 14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -5 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B(Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | (Seroconversion percentage difference (P |
| Estimated Value | -8 | |
| Confidence Interval |
(2-Sided) 95% -14 to -1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -4 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Diphtheria (Seroconversion percentage di |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -1 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -6 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | (Seroconversion percentage difference (P |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Seroconversion percentage difference (PUS1 - PUS2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -8 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA1 (Men ACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3 (Men ACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 287 | 123 | 283 | 137 |
| Diphtheria (N=287, N=123, N=283, N=137) |
1.8
|
1.54
|
1.45
|
1.77
|
| Tetanus (N=287, N=123, N=283, N=137) |
2.41
|
2.19
|
2.51
|
2.65
|
| PT (N=285, N=123, N=281, N=135) |
47
|
45
|
45
|
49
|
| FHA (N=286, N=123, N=281, N=135) |
102
|
97
|
99
|
112
|
| Pertactin (N=286, N=123, N=281, N=135) |
123
|
124
|
119
|
149
|
| Polio Type 1 (N=265, N=112, N=252, N=120) |
535
|
598
|
533
|
684
|
| Polio Type 2 (N=265, N=112, N=252, N=120) |
353
|
366
|
318
|
385
|
| Polio Type 3 (N=265, N=112, N=252, N=120) |
710
|
747
|
656
|
813
|
| Hepatitis B (N=243, N=104, N=237, N=118) |
2273
|
2045
|
1900
|
1993
|
| Hib (N=287, N=123, N=283, N=137) |
7.64
|
6.01
|
7.19
|
6.74
|
| PnC 4 (N=268, N=116, N=256, N=126) |
2.07
|
2.24
|
1.91
|
2.39
|
| PnC 6B (N=264, N=116, N=255, N=124) |
2.15
|
2.21
|
2.09
|
2.4
|
| PnC 9V (N=268, N=116, N=256, N=126) |
1.89
|
2.21
|
1.81
|
2.19
|
| PnC 14 (N=268, N=116, N=256, N=126) |
7.29
|
8.06
|
7.69
|
9.18
|
| PnC 18C (N=268, N=116, N=256, N=126) |
1.86
|
2.09
|
1.7
|
2.26
|
| PnC 19F (N=268, N=116, N=254, N=126) |
2.34
|
2.6
|
2.3
|
2.53
|
| PnC 23F (N=267, N=115, N=256, N=125) |
1.88
|
2.46
|
2.12
|
2.42
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.16 | |
| Confidence Interval |
(2-Sided) 95% 0.96 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Tetanus (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.96 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% 0.89 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.95 | |
| Confidence Interval |
() 95% 0.69 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.11 | |
| Confidence Interval |
(2-Sided) 95% 0.88 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | HIb (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 1.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95% 0.71 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.72 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Post-vaccination GMC; group ratio LA1:LA2) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Diphtheria (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Tetanus (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PT (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.93 | |
| Confidence Interval |
() 95% 0.78 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | FHA (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Pertactin (Post-vaccination GMC; group ratio LA3:LA4 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.59 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | HIb (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.07 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 4 (Post-vaccination GMT; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 0.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 6B (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 9V (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 14 (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.84 | |
| Confidence Interval |
() 95% 0.67 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 18C (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.75 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 0.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 19F (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 23F (Post-vaccination GMC; group ratio LA3:LA4) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. |
| Time Frame | 7 months of age (one month post-infant series) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA1 (Men ACWY-CRM + Infant Vaccines) | LA2 (Infant Vaccines Only) | LA3 (Men ACWY-CRM + Infant Vaccines) | LA4 (Infant Vaccines Only) |
|---|---|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 287 | 123 | 283 | 137 |
| Diphtheria(≥ 0.1 IU/mL) (N=287,N=123,N=283,N=137) |
99
|
98
|
99
|
99
|
| Tetanus (≥ 0.1 IU/mL) (N=287,N=123,N=283,N=137) |
100
|
100
|
100
|
100
|
| PT(≥ 4-fold rise) (N=285,N=123, N=281,N=135) |
85
|
86
|
85
|
82
|
| FHA (≥ 4-fold rise) (N=286,N=123, N=281,N=135) |
84
|
86
|
82
|
81
|
| Pertactin(≥ 4-fold rise)(N=286,N=123,N=281,N=135) |
81
|
87
|
86
|
88
|
| Polio Type 1 (≥1:8) (N=265,N=112,N=252,N=120) |
98
|
100
|
99
|
98
|
| Polio Type 2 (≥1:8) (N=265,N=112,N=252,N=120) |
97
|
99
|
98
|
98
|
| Polio Type 3 (≥1:8) (N=265,N=112,N=252,N=120) |
97
|
97
|
96
|
97
|
| Hepatitis B(≥10 mIU/mL)(N=243,N=104,N=237,N=118) |
100
|
100
|
100
|
100
|
| Hib (≥0.15 μg/mL) (N=287,N=123,N=283,N=137) |
99
|
98
|
97
|
99
|
| Hib (≥1.0 μg/mL) (N=287,N=123,N=283,N=137) |
95
|
93
|
93
|
96
|
| PnC 4 (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126) |
99
|
99
|
97
|
98
|
| PnC 6B (≥ 0.35 μg/mL) (N=264,N=116,N=255,N=124) |
91
|
86
|
91
|
90
|
| PnC 9V (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126) |
97
|
98
|
97
|
96
|
| PnC 14 (≥ 0.35 μg/mL) (N=268,N=116,N=256,N=126) |
99
|
97
|
98
|
98
|
| PnC 18C(≥ 0.35 μg/mL) (N=268,N=116,N=256, N=126) |
97
|
98
|
95
|
98
|
| PnC 19F (≥ 0.35 μg/mL)(N=268,N=116,N=254,N=126) |
97
|
98
|
98
|
96
|
| PnC 23F (≥ 0.35 μg/mL)(N=267,N=115,N=256, N=125) |
93
|
97
|
95
|
94
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2.2 to 4.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines) |
|---|---|---|
| Comments | Tetanus (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -1.9 to 2.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -7.7 to 7.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA(Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -9.2 to 5.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -6 | |
| Confidence Interval |
() 95% -12.9 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 1.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -4.6 to 2.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -3.2 to 5.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -1.5 to 3.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
() 95% -2.8 to 7.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4(Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 3.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B(Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 4 | |
| Confidence Interval |
(2-Sided) 95% -2.2 to 12.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3.9 to 3.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 6.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 2.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 2.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Seroconversion percentage difference (PLA1 - PLA2)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -4 | |
| Confidence Interval |
(2-Sided) 95% -8 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Diphtheria (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2.3 to 3.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Tetanus (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
() 95% -1.3 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PT (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 10.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | FHA(Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -7.1 to 8.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Pertactin (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -8 to 5.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 4.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -3 to 4.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4.4 to 4.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2.3 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -5.3 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
() 95% -6.6 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 4 (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4.2 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 6B (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -4 to 9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 9V (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -2.8 to 6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 14 (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3.7 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 18C (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -7.2 to 0.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 19F (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -0.8 to 7.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | US1 (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only) |
|---|---|---|
| Comments | PnC 23F (Seroconversion percentage difference (PLA3 - PLA4)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Seroconversion Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
() 95% -3.7 to 7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject |
|---|---|
| Description | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population Per protocol was defined as subjects who: received all the relevant doses of vaccine correctly provided evaluable serum samples at the relevant time points had no major protocol deviation as defined prior to database lock |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A (84, 74) |
12
|
3
|
| C (86, 73) |
53
|
8
|
| W (85, 73) |
80
|
4
|
| Y (84, 68) |
74
|
1
|
| Title | Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject |
|---|---|
| Description | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population Per protocol was defined as subjects who: received all the relevant doses of vaccine correctly provided evaluable serum samples at the relevant time points had no major protocol deviation as defined prior to database lock |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A (84, 74) |
10
|
1
|
| C (86, 73) |
50
|
7
|
| W (85, 73) |
71
|
4
|
| Y (84, 68) |
61
|
1
|
| Title | Persistence Antibodies Geometric Mean Titers - US Subject |
|---|---|
| Description | Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age. |
| Time Frame | 12 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A (84, 74) |
2.51
|
2.14
|
| C (86, 73) |
7.72
|
2.26
|
| W (85, 73) |
14
|
2.21
|
| Y (84, 68) |
11
|
2.14
|
| Title | Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject |
|---|---|
| Description | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 or 16 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1 (Men ACWY-CRM + Infant Vaccines) (12m) | LA2 (Infant Vaccines Only) (12m) | LA3 (Men ACWY-CRM + Infant Vaccines) (16m) | LA4 (Infant Vaccines Only) (12m) |
|---|---|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 206 | 78 | 229 | 102 |
| A (205, 78, 229, 101) |
29
|
1
|
18
|
1
|
| C (206, 78, 229, 102) |
62
|
4
|
32
|
2
|
| W (198, 70, 218, 98) |
95
|
4
|
72
|
5
|
| Y (195, 71, 212, 95) |
82
|
3
|
65
|
2
|
| Title | Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject |
|---|---|
| Description | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 or 16 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1 (Men ACWY-CRM + Infant Vaccines) (12m) | LA2 (Infant Vaccines Only) (12m) | LA3 (Men ACWY-CRM + Infant Vaccines) (16m) | LA4 (Infant Vaccines Only) (12m) |
|---|---|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 206 | 78 | 229 | 102 |
| A (205, 78, 229, 101) |
25
|
0
|
15
|
0
|
| C (206, 78, 229, 102) |
57
|
4
|
26
|
1
|
| W (198, 70, 218, 98) |
85
|
4
|
63
|
5
|
| Y (195, 71, 212, 95) |
72
|
3
|
52
|
0
|
| Title | Persistence Antibodies Geometric Mean Titers - LA Subjects |
|---|---|
| Description | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age. |
| Time Frame | 12 or 16 Months of Age (one month pre-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1 (Men ACWY-CRM + Infant Vaccines) (12m) | LA2 (Infant Vaccines Only) (12m) | LA3 (Men ACWY-CRM + Infant Vaccines) (16m) | LA4 (Infant Vaccines Only) (12m) |
|---|---|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 206 | 78 | 229 | 102 |
| A (205, 78, 229, 101) |
4.26
|
2.02
|
2.96
|
2.02
|
| C (206, 78, 229, 102) |
12
|
2.18
|
4.14
|
2.05
|
| W (198, 70, 218, 98) |
31
|
2.34
|
14
|
2.33
|
| Y (195, 71, 212, 95) |
18
|
2.2
|
9.45
|
2.04
|
| Title | Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A Pre-vaccination (84, 74) |
12
|
3
|
| A Post-vaccination (84, 74) |
94
|
78
|
| C Pre-vaccination (86, 73) |
53
|
8
|
| C Post-vaccination (86, 73) |
99
|
95
|
| W Pre-vaccination (85, 73) |
80
|
4
|
| W Post-vaccination (85, 73) |
100
|
73
|
| Y Pre-vaccination (84, 68) |
74
|
1
|
| Y Post-vaccination (84, 68) |
100
|
62
|
| Title | Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A Pre-vaccination (84, 74) |
10
|
1
|
| A Post-vaccination (84, 74) |
94
|
72
|
| C Pre-vaccination (86, 73) |
50
|
7
|
| C Post-vaccination (86, 73) |
98
|
90
|
| W Pre-vaccination (85, 73) |
71
|
4
|
| W Post-vaccination (85, 73) |
100
|
58
|
| Y Pre-vaccination (84, 68) |
61
|
1
|
| Y Post-vaccination (84, 68) |
100
|
56
|
| Title | Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 86 | 74 |
| A Pre-vaccination (84, 74) |
5
|
1
|
| A Post-vaccination (84, 74) |
90
|
55
|
| C Pre-vaccination (86, 73) |
35
|
0
|
| C Post-vaccination (86, 73) |
95
|
78
|
| W Pre-vaccination (85, 73) |
48
|
3
|
| W Post-vaccination (85, 73) |
100
|
38
|
| Y Pre-vaccination (84, 68) |
45
|
1
|
| Y Post-vaccination (84, 68) |
100
|
41
|
| Title | Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | US1A (MenACWY- CRM + Infant Vaccines ) | US2 (Infant Vaccine Only) |
|---|---|---|
| Arm/Group Description | US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines. | received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY. |
| Measure Participants | 84 | 74 |
| A Pre-vaccination (84, 74) |
2.51
|
2.14
|
| A Post-vaccination (84, 74) |
77
|
17
|
| C Pre-vaccination (86, 73) |
7.72
|
2.26
|
| C Post-vaccination (86, 73) |
227
|
35
|
| W Pre-vaccination (85, 73) |
14
|
2.21
|
| W Post-vaccination (85, 73) |
416
|
11
|
| Y Pre-vaccination (84, 68) |
11
|
2.14
|
| Y Post-vaccination (84, 68) |
395
|
10
|
| Title | Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 or 17 Months of Age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA3A (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. |
| Measure Participants | 103 | 122 |
| A Pre-vaccination (103, 120) |
28
|
18
|
| A Post-vaccination (103,120) |
94
|
95
|
| C Pre-vaccination (102,122) |
61
|
30
|
| C Post-vaccination (102,122) |
98
|
98
|
| W Pre-vaccination (98,112) |
97
|
71
|
| W Post-vaccination (98,112) |
100
|
100
|
| Y Pre-vaccination (98,109) |
78
|
61
|
| Y Post-vaccination (98,109) |
99
|
99
|
| Title | Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 or 17 Months of Age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA3A (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. |
| Measure Participants | 103 | 122 |
| A Pre-vaccination (103, 120) |
23
|
13
|
| A Post-vaccination (103,120) |
94
|
95
|
| C Pre-vaccination (102,122) |
57
|
22
|
| C Post-vaccination (102,122) |
97
|
98
|
| W Pre-vaccination (98,112) |
84
|
62
|
| W Post-vaccination (98,112) |
99
|
100
|
| Y Pre-vaccination (98,109) |
67
|
47
|
| Y Post-vaccination (98,109) |
99
|
99
|
| Title | Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 or 17 Months of Age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA3A (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. |
| Measure Participants | 103 | 122 |
| A Pre-vaccination (103, 120) |
16
|
9
|
| A Post-vaccination (103, 120) |
93
|
94
|
| C Pre-vaccination (102, 122) |
47
|
18
|
| C Post-vaccination (102, 122) |
95
|
96
|
| W Pre-vaccination (98,112) |
64
|
50
|
| W Post-vaccination (98, 112) |
99
|
100
|
| Y Pre-vaccination (98,109) |
53
|
32
|
| Y Post-vaccination (98, 109) |
99
|
98
|
| Title | Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. |
| Time Frame | 13 or 17 Months of Age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA3A (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. |
| Measure Participants | 103 | 122 |
| A Pre-vaccination (103, 120) |
3.83
|
2.95
|
| A Post-vaccination (103, 120) |
112
|
146
|
| C Pre-vaccination (102, 122) |
11
|
3.83
|
| C Post-vaccination (102, 122) |
279
|
283
|
| W Pre-vaccination (98, 112) |
28
|
13
|
| W Post-vaccination (98, 112) |
762
|
727
|
| Y Pre-vaccination (98, 109) |
16
|
8.1
|
| Y Post-vaccination (98, 109) |
550
|
590
|
| Title | Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. |
| Measure Participants | 87 | 99 |
| PnC 4 (N=86, N=99) |
2.9
|
3.24
|
| PnC 6B (N=86, N=99) |
6.82
|
8.58
|
| PnC 9V (N=86, N=99) |
2.8
|
3.13
|
| PnC 14 (N=86, N=99) |
12
|
15
|
| PnC 18C (N=87, N=98) |
2.76
|
2.71
|
| PnC 19F(N=86, N=99) |
3.63
|
3.48
|
| PnC 23F (N=87, N=99) |
5.31
|
5.63
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.04 | |
| Confidence Interval |
() 95% 0.81 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Post-vaccination GMC; group ratio US1A:US1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects |
|---|---|
| Description | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | US1A (MenACWY-CRM + Infant Vaccines) | US1B (MenACWY-CRM + Infant Vaccines) | US2 (Infant Vaccines Only) |
|---|---|---|---|
| Arm/Group Description | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age. | US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age. | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. |
| Measure Participants | 87 | 99 | 81 |
| PnC 4 (N=86, N=99, N=81) |
91
|
90
|
84
|
| PnC 6B (N=86, N=99, N=80) |
100
|
96
|
99
|
| PnC 9V (N=86, N=99, N=80) |
87
|
91
|
86
|
| PnC 14 (N=86, N=99, N=81) |
99
|
100
|
100
|
| PnC 18C (N=87, N=98, N=81) |
86
|
92
|
94
|
| PnC 19F(N=86, N=99, N=80) |
97
|
93
|
99
|
| PnC 23F (N=87, N=99, N=80) |
93
|
95
|
99
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (percentage difference (US1A - US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -8 to 10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (percentage difference (US1A - US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 4 | |
| Confidence Interval |
(2-Sided) 95% 0 to 10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (percentage difference (US1A - US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -4 | |
| Confidence Interval |
(2-Sided) 95% -13 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (percentage difference (US1A - US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -6 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (percentage difference (US1A:US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -6 | |
| Confidence Interval |
(2-Sided) 95% -15 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (percentage difference (US1A:US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 4 | |
| Confidence Interval |
(2-Sided) 95% -4 to 11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 239F (percentage difference (US1A:US1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -10 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA1B (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. |
| Measure Participants | 97 | 97 |
| PnC 4 (N=97, N=97) |
3.16
|
4.02
|
| PnC 6B (N=96, N=97) |
4.52
|
5.61
|
| PnC 9V (N=97, N=97) |
2.79
|
3.77
|
| PnC 14(N=97, N=97) |
8.91
|
14
|
| PnC 18C (N=97, N=97) |
2.15
|
2.77
|
| PnC 19F (N=97, N=97) |
3.26
|
4.26
|
| PnC 23F (N=97, N=97) |
4.38
|
5.92
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 1.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.65 | |
| Confidence Interval |
(2-Sided) 95% 0.51 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.56 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F |
| Time Frame | 13 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA1A (Men ACWY-CRM + Infant Vaccines) | LA1B (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. | LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age. |
| Measure Participants | 97 | 97 |
| PnC 4 (N=97, N=97) |
93
|
95
|
| PnC 6B (N=96, N=97) |
86
|
89
|
| PnC 9V (N=97, N=97) |
92
|
95
|
| PnC 14 (N=97, N=97) |
99
|
100
|
| PnC 18C (N=97, N=97) |
80
|
95
|
| PnC 19F (N=97, N=97) |
90
|
93
|
| PnC 23F (N=97, N=97) |
95
|
95
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 4 (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -9.6 to 5.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 6B (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -11.9 to 7.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 9V (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -10.9 to 4.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 14 (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -5.6 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 18C (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -14 | |
| Confidence Interval |
(2-Sided) 95% -24.1 to -5.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 19F (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -11.6 to 5.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PnC 23F (percentage difference (LA1A - LA1B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -7 to 7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens |
| Time Frame | 17 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA3A (Men ACWY-CRM + Infant Vaccines) | LA3B (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY. |
| Measure Participants | 118 | 101 |
| Diphtheria (N=118, N=101) |
5.4
|
5.16
|
| Tetanus (N=118, N=101) |
6.17
|
6.58
|
| PT (N=113, N=99) |
68
|
62
|
| FHA (N=113, N=99) |
245
|
215
|
| Pertactin (N=113, N=99) |
238
|
197
|
| Hib (N=117, N=101) |
35
|
41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (Post-vaccination GMC; group ratio LA3A:LA3B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.11 | |
| Confidence Interval |
(2-Sided) 95% 0.88 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA (Post-vaccination GMC; group ratio LA3A:LA3B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.14 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 1.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.21 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (Post-vaccination GMC; group ratio LA3A:LA3B) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 1.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens |
| Time Frame | 17 months of age (one month post-toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | LA3A (Men ACWY-CRM + Infant Vaccines) | LA3B (Men ACWY-CRM + Infant Vaccines) |
|---|---|---|
| Arm/Group Description | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib. | LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY. |
| Measure Participants | 118 | 101 |
| Diphtheria (≥1.0 IU/mL) (N=118, N=101) |
98
|
98
|
| Tetanus (≥1.0 IU/mL) (N=118, N=101) |
98
|
98
|
| PT (≥4 fold rise) (N=113, N=99) |
89
|
84
|
| FHA (≥4-fold rise) (N=113, N=99) |
87
|
88
|
| Pertactin (≥4-fold rise) (N=113, N=99) |
89
|
88
|
| Hib (≥0.15 μg/mL) (N=117, N=101) |
100
|
100
|
| Hib (≥1.0 μg/mL) (N=117, N=101) |
100
|
99
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Diphtheria (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
() 95% -4.2 to 5.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Tetanus (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -4.2 to 5.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | PT (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 6 | |
| Confidence Interval |
() 95% -3.6 to 15.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | FHA (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -10.2 to 8.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Pertactin (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -7.2 to 10.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -3.1 to 3.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | US1A (MenACWY- CRM + Infant Vaccines), US2 (Infant Vaccine Only) |
|---|---|---|
| Comments | Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B)) | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -2.2 to 5.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA2 (Infant Vaccines Only) | LA4 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 78 | 102 |
| A Pre-vaccination (78, 101) |
0
|
0
|
| A Post-vaccination ((78, 101) |
74
|
97
|
| C Pre-vaccination (78, 102) |
4
|
1
|
| C Post-vaccination (78, 102) |
91
|
100
|
| W Pre-vaccination (70, 98) |
4
|
5
|
| W Post-vaccination (70, 98) |
79
|
100
|
| Y Pre-vaccination (71, 95) |
3
|
0
|
| Y Post-vaccination (71, 95) |
72
|
100
|
| Title | Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects |
|---|---|
| Description | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. |
| Time Frame | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on per protocol population |
| Arm/Group Title | LA2 (Infant Vaccines Only) | LA4 (Infant Vaccines Only) |
|---|---|---|
| Arm/Group Description | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age. | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age. |
| Measure Participants | 78 | 108 |
| A Pre-vaccination (78, 101) |
2.02
|
2.02
|
| A Post-vaccination (78, 101) |
25
|
128
|
| C Pre-vaccination (78, 102) |
2.18
|
2.05
|
| C Post-vaccination (78, 102) |
45
|
501
|
| W Pre-vaccination (70, 98) |
2.34
|
2.33
|
| W Post-vaccination (70, 98) |
22
|
394
|
| Y Pre-vaccination (71, 95) |
2.2
|
2.04
|
| Y Post-vaccination (71, 95) |
15
|
329
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | US1+US3 | US2+US4A+US4B | US4C | LA1+LA3+LA5 | LA2+4+6AB | LA6C | ||||||
| Arm/Group Description | Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B). | Groups Infant Vaccines only (US2, US4A, and US4B) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received: One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A). Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) | US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age. | Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B). LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received: Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A) DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B). Concomitantly the fourth dose of MenACWY (LA5). | Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B). | LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age | ||||||
All Cause Mortality |
||||||||||||
| US1+US3 | US2+US4A+US4B | US4C | LA1+LA3+LA5 | LA2+4+6AB | LA6C | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| US1+US3 | US2+US4A+US4B | US4C | LA1+LA3+LA5 | LA2+4+6AB | LA6C | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 58/995 (5.8%) | 18/301 (6%) | 14/203 (6.9%) | 173/2026 (8.5%) | 84/824 (10.2%) | 12/183 (6.6%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| IRON DEFICIENCY ANAEMIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 1/183 (0.5%) | ||||||
| LYMPHADENITIS | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| CYANOSIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| PULMONARY VALVE STENOSIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Congenital, familial and genetic disorders | ||||||||||||
| ATRIAL SEPTAL DEFECT | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FALLOT'S TETRALOGY | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HYPOSPADIAS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| OPTIC NERVE HYPOPLASIA | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PYLORIC STENOSIS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| HAEMATOTYMPANUM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Eye disorders | ||||||||||||
| BLEPHARITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| DIARRHOEA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 8/2026 (0.4%) | 4/824 (0.5%) | 0/183 (0%) | ||||||
| DIARRHOEA HAEMORRHAGIC | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| GASTRITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| GASTROOESOPHAGEAL REFLUX DISEASE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| HAEMATOCHEZIA | 1/995 (0.1%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| INGUINAL HERNIA | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| INTESTINAL OBSTRUCTION | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| INTUSSUSCEPTION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| NAUSEA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PERITONITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| STOMATITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| VOMITING | 1/995 (0.1%) | 1/301 (0.3%) | 0/203 (0%) | 4/2026 (0.2%) | 3/824 (0.4%) | 1/183 (0.5%) | ||||||
| General disorders | ||||||||||||
| OEDEMA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PYREXIA | 3/995 (0.3%) | 0/301 (0%) | 0/203 (0%) | 5/2026 (0.2%) | 5/824 (0.6%) | 1/183 (0.5%) | ||||||
| Immune system disorders | ||||||||||||
| DRUG HYPERSENSITIVITY | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FOOD ALLERGY | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HYPOGAMMAGLOBULINAEMIA | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Infections and infestations | ||||||||||||
| ABSCESS LIMB | 1/995 (0.1%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| ABSCESS NECK | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| ABSCESS ORAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| ACARODERMATITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| ACUTE SINUSITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| ARTHRITIS BACTERIAL | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BACTERAEMIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BACTERIAL DIARRHOEA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 3/2026 (0.1%) | 6/824 (0.7%) | 0/183 (0%) | ||||||
| BOTULISM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BRONCHIOLITIS | 10/995 (1%) | 3/301 (1%) | 2/203 (1%) | 32/2026 (1.6%) | 16/824 (1.9%) | 6/183 (3.3%) | ||||||
| BRONCHITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 6/2026 (0.3%) | 1/824 (0.1%) | 2/183 (1.1%) | ||||||
| BRONCHITIS VIRAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BRONCHOPNEUMONIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| CELLULITIS | 3/995 (0.3%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 1/183 (0.5%) | ||||||
| CROUP INFECTIOUS | 1/995 (0.1%) | 0/301 (0%) | 1/203 (0.5%) | 3/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| DENGUE FEVER | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| ENTERITIS INFECTIOUS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| EXANTHEMA SUBITUM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FEBRILE INFECTION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| GASTROENTERITIS | 2/995 (0.2%) | 0/301 (0%) | 2/203 (1%) | 14/2026 (0.7%) | 4/824 (0.5%) | 0/183 (0%) | ||||||
| GASTROENTERITIS VIRAL | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| IMPETIGO | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| INFECTIOUS MONONUCLEOSIS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| INFLUENZA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| LOWER RESPIRATORY TRACT INFECTION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| LUNG INFECTION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| OSTEOMYELITIS | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| OTITIS MEDIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 4/824 (0.5%) | 0/183 (0%) | ||||||
| OTITIS MEDIA ACUTE | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PERIORBITAL CELLULITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| PERTUSSIS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| PHARYNGITIS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PNEUMONIA | 4/995 (0.4%) | 2/301 (0.7%) | 1/203 (0.5%) | 37/2026 (1.8%) | 9/824 (1.1%) | 2/183 (1.1%) | ||||||
| PNEUMONIA BACTERIAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 5/2026 (0.2%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| PNEUMONIA PRIMARY ATYPICAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PNEUMONIA VIRAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS | 4/995 (0.4%) | 4/301 (1.3%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 1/183 (0.5%) | ||||||
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | 3/995 (0.3%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| RESPIRATORY TRACT INFECTION | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| RESPIRATORY TRACT INFECTION VIRAL | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| SEPSIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| SINUSITIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| STAPHYLOCOCCAL ABSCESS | 2/995 (0.2%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| STAPHYLOCOCCAL INFECTION | 2/995 (0.2%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| STAPHYLOCOCCAL SKIN INFECTION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| SUBCUTANEOUS ABSCESS | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 4/2026 (0.2%) | 0/824 (0%) | 0/183 (0%) | ||||||
| UPPER RESPIRATORY TRACT INFECTION | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| URINARY TRACT INFECTION | 1/995 (0.1%) | 1/301 (0.3%) | 0/203 (0%) | 9/2026 (0.4%) | 8/824 (1%) | 0/183 (0%) | ||||||
| VARICELLA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| VIRAL DIARRHOEA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| VIRAL INFECTION | 1/995 (0.1%) | 0/301 (0%) | 1/203 (0.5%) | 1/2026 (0%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| VIRAL PHARYNGITIS | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| VULVAL ABSCESS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| ACCIDENTAL DRUG INTAKE BY CHILD | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| ACCIDENTAL EXPOSURE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BURNS SECOND DEGREE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FOREIGN BODY | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HEAD INJURY | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| LIMB TRAUMATIC AMPUTATION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| RIB FRACTURE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| ROAD TRAFFIC ACCIDENT | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| SKULL FRACTURE | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| THERMAL BURN | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| TRAUMATIC BRAIN INJURY | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| UPPER LIMB FRACTURE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| COW'S MILK INTOLERANCE | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| DEHYDRATION | 5/995 (0.5%) | 1/301 (0.3%) | 2/203 (1%) | 1/2026 (0%) | 1/824 (0.1%) | 2/183 (1.1%) | ||||||
| DIABETES MELLITUS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| DIABETIC KETOACIDOSIS | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HYPOGLYCAEMIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HYPONATRAEMIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| SYNOSTOSIS | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| ACUTE MYELOID LEUKAEMIA | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BRAIN NEOPLASM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| COMPLEX PARTIAL SEIZURES | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| CONVULSION | 2/995 (0.2%) | 1/301 (0.3%) | 0/203 (0%) | 5/2026 (0.2%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FEBRILE CONVULSION | 1/995 (0.1%) | 0/301 (0%) | 1/203 (0.5%) | 13/2026 (0.6%) | 4/824 (0.5%) | 1/183 (0.5%) | ||||||
| GRAND MAL CONVULSION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| PSYCHOMOTOR SKILLS IMPAIRED | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| SUBARACHNOID HAEMORRHAGE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| TONIC CONVULSION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| NEPHROTIC SYNDROME | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| APNOEA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| ASTHMA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 6/2026 (0.3%) | 3/824 (0.4%) | 0/183 (0%) | ||||||
| BRONCHIAL HYPERREACTIVITY | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| BRONCHOSPASM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 5/2026 (0.2%) | 2/824 (0.2%) | 1/183 (0.5%) | ||||||
| CHOKING | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| FOREIGN BODY ASPIRATION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| HYPOXIA | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| LARYNGOSPASM | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| PULMONARY HYPERTENSION | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| RESPIRATORY DISORDER | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 2/2026 (0.1%) | 0/824 (0%) | 0/183 (0%) | ||||||
| SLEEP APNOEA SYNDROME | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| STATUS ASTHMATICUS | 0/995 (0%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| TACHYPNOEA | 0/995 (0%) | 1/301 (0.3%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| WHEEZING | 2/995 (0.2%) | 0/301 (0%) | 1/203 (0.5%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| RASH | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| URTICARIA | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| Surgical and medical procedures | ||||||||||||
| INTESTINAL OPERATION | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 1/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| Vascular disorders | ||||||||||||
| KAWASAKI'S DISEASE | 1/995 (0.1%) | 0/301 (0%) | 0/203 (0%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| US1+US3 | US2+US4A+US4B | US4C | LA1+LA3+LA5 | LA2+4+6AB | LA6C | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 957/995 (96.2%) | 279/301 (92.7%) | 202/203 (99.5%) | 1946/2026 (96.1%) | 795/824 (96.5%) | 178/183 (97.3%) | ||||||
| Eye disorders | ||||||||||||
| CONJUNCTIVITIS | 93/995 (9.3%) | 30/301 (10%) | 29/203 (14.3%) | 68/2026 (3.4%) | 28/824 (3.4%) | 9/183 (4.9%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| DIARRHOEA | 289/995 (29%) | 91/301 (30.2%) | 78/203 (38.4%) | 597/2026 (29.5%) | 287/824 (34.8%) | 57/183 (31.1%) | ||||||
| FLATULENCE | 23/995 (2.3%) | 8/301 (2.7%) | 12/203 (5.9%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| GASTROOESOPHAGEAL REFLUX DISEASE | 49/995 (4.9%) | 11/301 (3.7%) | 12/203 (5.9%) | 53/2026 (2.6%) | 29/824 (3.5%) | 1/183 (0.5%) | ||||||
| TEETHING | 83/995 (8.3%) | 28/301 (9.3%) | 30/203 (14.8%) | 11/2026 (0.5%) | 2/824 (0.2%) | 0/183 (0%) | ||||||
| VOMITING | 217/995 (21.8%) | 69/301 (22.9%) | 61/203 (30%) | 486/2026 (24%) | 228/824 (27.7%) | 39/183 (21.3%) | ||||||
| General disorders | ||||||||||||
| INJECTION SITE ERYTHEMA | 280/995 (28.1%) | 108/301 (35.9%) | 100/203 (49.3%) | 1245/2026 (61.5%) | 548/824 (66.5%) | 117/183 (63.9%) | ||||||
| INJECTION SITE INDURATION | 204/995 (20.5%) | 101/301 (33.6%) | 78/203 (38.4%) | 745/2026 (36.8%) | 333/824 (40.4%) | 90/183 (49.2%) | ||||||
| INJECTION SITE PAIN | 651/995 (65.4%) | 196/301 (65.1%) | 147/203 (72.4%) | 1592/2026 (78.6%) | 698/824 (84.7%) | 164/183 (89.6%) | ||||||
| IRRITABILITY | 800/995 (80.4%) | 240/301 (79.7%) | 171/203 (84.2%) | 1120/2026 (55.3%) | 474/824 (57.5%) | 110/183 (60.1%) | ||||||
| MALAISE | 0/995 (0%) | 0/301 (0%) | 0/203 (0%) | 136/2026 (6.7%) | 73/824 (8.9%) | 5/183 (2.7%) | ||||||
| PYREXIA | 296/995 (29.7%) | 94/301 (31.2%) | 74/203 (36.5%) | 748/2026 (36.9%) | 341/824 (41.4%) | 74/183 (40.4%) | ||||||
| Infections and infestations | ||||||||||||
| BRONCHIOLITIS | 108/995 (10.9%) | 34/301 (11.3%) | 25/203 (12.3%) | 180/2026 (8.9%) | 52/824 (6.3%) | 36/183 (19.7%) | ||||||
| BRONCHITIS | 10/995 (1%) | 6/301 (2%) | 5/203 (2.5%) | 219/2026 (10.8%) | 95/824 (11.5%) | 17/183 (9.3%) | ||||||
| CROUP INFECTIOUS | 44/995 (4.4%) | 12/301 (4%) | 15/203 (7.4%) | 2/2026 (0.1%) | 1/824 (0.1%) | 0/183 (0%) | ||||||
| GASTROENTERITIS | 49/995 (4.9%) | 18/301 (6%) | 6/203 (3%) | 48/2026 (2.4%) | 35/824 (4.2%) | 3/183 (1.6%) | ||||||
| NASOPHARYNGITIS | 41/995 (4.1%) | 9/301 (3%) | 11/203 (5.4%) | 375/2026 (18.5%) | 192/824 (23.3%) | 27/183 (14.8%) | ||||||
| OTITIS MEDIA | 258/995 (25.9%) | 76/301 (25.2%) | 62/203 (30.5%) | 26/2026 (1.3%) | 17/824 (2.1%) | 2/183 (1.1%) | ||||||
| OTITIS MEDIA ACUTE | 42/995 (4.2%) | 15/301 (5%) | 13/203 (6.4%) | 37/2026 (1.8%) | 15/824 (1.8%) | 7/183 (3.8%) | ||||||
| RESPIRATORY TRACT INFECTION | 2/995 (0.2%) | 0/301 (0%) | 0/203 (0%) | 163/2026 (8%) | 71/824 (8.6%) | 5/183 (2.7%) | ||||||
| UPPER RESPIRATORY TRACT INFECTION | 340/995 (34.2%) | 108/301 (35.9%) | 74/203 (36.5%) | 16/2026 (0.8%) | 4/824 (0.5%) | 0/183 (0%) | ||||||
| VIRAL INFECTION | 82/995 (8.2%) | 22/301 (7.3%) | 20/203 (9.9%) | 44/2026 (2.2%) | 28/824 (3.4%) | 1/183 (0.5%) | ||||||
| Nervous system disorders | ||||||||||||
| CRYING | 558/995 (56.1%) | 154/301 (51.2%) | 124/203 (61.1%) | 927/2026 (45.8%) | 419/824 (50.8%) | 98/183 (53.6%) | ||||||
| SOMNOLENCE | 676/995 (67.9%) | 184/301 (61.1%) | 141/203 (69.5%) | 1198/2026 (59.1%) | 513/824 (62.3%) | 110/183 (60.1%) | ||||||
| Psychiatric disorders | ||||||||||||
| EATING DISORDERS | 425/995 (42.7%) | 122/301 (40.5%) | 93/203 (45.8%) | 607/2026 (30%) | 263/824 (31.9%) | 69/183 (37.7%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| BRONCHOSPASM | 15/995 (1.5%) | 0/301 (0%) | 3/203 (1.5%) | 38/2026 (1.9%) | 7/824 (0.8%) | 15/183 (8.2%) | ||||||
| COUGH | 64/995 (6.4%) | 20/301 (6.6%) | 15/203 (7.4%) | 41/2026 (2%) | 24/824 (2.9%) | 4/183 (2.2%) | ||||||
| NASAL CONGESTION | 60/995 (6%) | 15/301 (5%) | 18/203 (8.9%) | 6/2026 (0.3%) | 1/824 (0.1%) | 1/183 (0.5%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| DERMATITIS ATOPIC | 29/995 (2.9%) | 9/301 (3%) | 13/203 (6.4%) | 26/2026 (1.3%) | 16/824 (1.9%) | 1/183 (0.5%) | ||||||
| DERMATITIS DIAPER | 62/995 (6.2%) | 21/301 (7%) | 13/203 (6.4%) | 8/2026 (0.4%) | 4/824 (0.5%) | 0/183 (0%) | ||||||
| ECZEMA | 105/995 (10.6%) | 32/301 (10.6%) | 21/203 (10.3%) | 0/2026 (0%) | 0/824 (0%) | 0/183 (0%) | ||||||
| RASH | 154/995 (15.5%) | 33/301 (11%) | 39/203 (19.2%) | 323/2026 (15.9%) | 136/824 (16.5%) | 32/183 (17.5%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00474526
Other Study ID Numbers:
- V59P14
First Posted:
May 17, 2007
Last Update Posted:
Mar 24, 2014
Last Verified:
Feb 1, 2014