Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00667602
Collaborator
(none)
662
28
3
31
23.6
0.8
Study Details
Study Description
Brief Summary
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
662 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Jul 1, 2009
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MenACWY-CRM197 (2 doses) + Concomitant Vaccines Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months. |
Biological: MenACWY-CRM197 (two doses)
Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
Biological: PCV7
One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
Biological: DTPa-IPV-HepB-Hib
One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
|
| Experimental: MenACWY-CRM197 (1 dose) + Concomitant Vaccines Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age. |
Biological: PCV7
One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
Biological: DTPa-IPV-HepB-Hib
One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
Biological: MenACWY-CRM197 (one dose)
One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
|
| Active Comparator: MenC (1 dose) + Concomitant Vaccines Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age. |
Biological: MenC
One 0.5mL dose of MenC vaccine was administered by intramuscular injection.
Biological: PCV7
One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
Biological: DTPa-IPV-HepB-Hib
One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
|
Outcome Measures
Primary Outcome Measures
- Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C [1 month postvaccination]
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.
Secondary Outcome Measures
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C [1 month postvaccination]
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y [1 month postvaccination.]
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y.
- Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y [1 month postvaccination.]
Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y. Serogroup C is not shown here as it is shown in other outcome measures.
- Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C [1 month postvaccination]
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.
- Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y [1 month postvaccination]
Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.
- Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y [1 month postvaccination]
The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.
- Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) [1 month postvaccination]
The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed. For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration. Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL. Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8. HepB (HBV): primary endpoint ELISA >=10mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.
- Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) [1 month postvaccination]
To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age. Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL.
- Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C [1 month postvaccination and 6-18 months postvaccination.]
Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).
- Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y [1 month postvaccination 6-18 months postvaccination]
Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).
- Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C [1 month postvaccination and 6-18 months postvaccination.]
Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).
- Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y [6-18 months postvaccination.]
Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).
- Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C [1 month postvaccination.]
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.
- Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y [1 month postvaccination.]
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.
- Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C [1 month postvaccination.]
Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.
- Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y [1 month postvaccination.]
Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.
- Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination [From day 1 to day 7 postvaccination]
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups. safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 8 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry
Exclusion Criteria:
-
who previously received any meningococcal vaccine;
-
who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
-
who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
- diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 22 | Bad Kreuznach | Germany | 55543 | |
| 2 | Site 38 | Bad Lobenstein | Germany | 07356 | |
| 3 | Site 24 | Balve | Germany | 58802 | |
| 4 | Site 3 | Berlin | Germany | 12589 | |
| 5 | Site 27 | Berlin | Germany | 12619 | |
| 6 | Site 20 | Berlin | Germany | 12627 | |
| 7 | Site 26 | Berlin | Germany | 12627 | |
| 8 | Site 13 | Berlin | Germany | 13189 | |
| 9 | Site 31 | Berlin | Germany | 13189 | |
| 10 | Site 25 | Berlin | Germany | 13347 | |
| 11 | Site 15 | Bönnigheim | Germany | 74357 | |
| 12 | Site 39 | Eschwege | Germany | 37269 | |
| 13 | Site 32 | Flensburg | Germany | 24937 | |
| 14 | Site 16 | Frankenthal | Germany | 67227 | |
| 15 | Site 33 | Glücksburg | Germany | 24960 | |
| 16 | Site 35 | Hamburg | Germany | 22147 | |
| 17 | Site 2 | Kehl | Germany | 77694 | |
| 18 | Site 28 | Mainz | Germany | 55127 | |
| 19 | Site 44 | Mainz | Germany | 55131 | |
| 20 | Site 43 | München-Ramersdorf | Germany | 81669 | |
| 21 | Site 42 | Neuhaus am Rennweg | Germany | 98724 | |
| 22 | Site 21 | Neumünster | Germany | 24534 | |
| 23 | Site 9 | Neumünster | Germany | 24534 | |
| 24 | Site 10 | Oberstenfeld | Germany | 71720 | |
| 25 | Site 4 | Stuttgart | Germany | 70193 | |
| 26 | Site 19 | Stuttgart | Germany | 70469 | |
| 27 | Site 30 | Weilheim i OB | Germany | 82362 | |
| 28 | Site 6 | Wiesloch | Germany | 69168 |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00667602
Other Study ID Numbers:
- V59P22
- 2007-004754-82
First Posted:
Apr 28, 2008
Last Update Posted:
Nov 7, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | All participants enrolled were included in the trial. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Period Title: Overall Study | |||
| STARTED | 219 | 228 | 215 |
| COMPLETED | 211 | 213 | 197 |
| NOT COMPLETED | 8 | 15 | 18 |
Baseline Characteristics
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines | Total |
|---|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Total of all reporting groups |
| Overall Participants | 219 | 228 | 215 | 662 |
| Age (Days) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Days] |
208.4
(23.7)
|
209.8
(22.2)
|
209.3
(21.9)
|
209.2
(22.6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
105
47.9%
|
106
46.5%
|
94
43.7%
|
305
46.1%
|
| Male |
114
52.1%
|
122
53.5%
|
121
56.3%
|
357
53.9%
|
Outcome Measures
| Title | Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis. |
| Arm/Group Title | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 175 | 153 |
| Number (95% Confidence Interval) [Percentages of subjects] |
83
|
92
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% . | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -8 | |
| Confidence Interval |
(2-Sided) 95% -15 to -1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 175 | 153 |
| Number (95% Confidence Interval) [Percentages of subjects] |
90
|
97
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -7 | |
| Confidence Interval |
(2-Sided) 95% -13 to -2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y |
|---|---|
| Description | Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 167 | 153 |
| titer ≥ 1:8, prevacc, Men A, (N=159,23) |
21
|
0
|
| titer ≥ 1:8, postvacc, Men A (N=166,23) |
93
|
0
|
| titer ≥ 1:8, prevacc, Men C (N=161,152) |
78
|
6
|
| titer ≥ 1:8, postvacc, Men C (N=167,153) |
99
|
92
|
| titer ≥ 1:8, prevacc, Men W, (N=157,23) |
68
|
0
|
| titer ≥ 1:8, postvacc, Men W, (N=165,22) |
98
|
5
|
| titer ≥ 1:8, prevacc, Men Y, (N=156, 23) |
69
|
0
|
| titer ≥ 1:8, postvacc, Men Y, (N=163,22) |
96
|
5
|
| titer ≥ 1:4, prevacc, Men A, (N=159,23) |
26
|
0
|
| titer ≥ 1:4, postvacc, Men A, (N=166,23) |
95
|
0
|
| titer ≥ 1:4, prevacc, Men C, (N=161,152) |
88
|
7
|
| titer ≥ 1:4, postvacc, Men C, (N=167,153) |
99
|
97
|
| titer ≥ 1:4, prevacc, Men W, (N=157,23) |
74
|
0
|
| titer ≥ 1:4, postvacc, Men W, (N=165,22) |
98
|
5
|
| titer ≥ 1:4, prevacc, Men Y, (N=156,23) |
78
|
0
|
| titer ≥ 1:4, postvacc, Men Y, (N=163,22) |
99
|
5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PMenACWY - PMenC > -10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 72 | |
| Confidence Interval |
(2-Sided) 95% 64 to 79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PMenACWY - PMenC > -10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 7 | |
| Confidence Interval |
(2-Sided) 95% 3 to 13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PMenACWY - PMenC > -10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 80 | |
| Confidence Interval |
(2-Sided) 95% 73 to 86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PMenACWY - PMenC > -10%). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -2 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y |
|---|---|
| Description | Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y. Serogroup C is not shown here as it is shown in other outcome measures. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|
| Arm/Group Description | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 175 |
| titer ≥ 1:8, pre-vacc, Men A, (N=171) |
1
|
| titer ≥ 1:8, post-vacc, Men A, (N=172) |
49
|
| titer ≥ 1:8, pre-vacc, Men W, (N=168) |
3
|
| titer ≥ 1:8, post-vacc, Men W, (N=170) |
61
|
| titer ≥ 1:8, pre-vacc, Men Y, (N=160) |
3
|
| titer ≥ 1:8, post-vacc, Men Y, (N=167) |
50
|
| titer ≥ 1:4, pre-vacc, Men A, (N=171) |
1
|
| titer ≥ 1:4, post-vacc, Men A, (N=172) |
58
|
| titer ≥ 1:4, pre-vacc, Men W, (N=168) |
4
|
| titer ≥ 1:4, post-vacc, Men W, (N=170) |
62
|
| titer ≥ 1:4, pre-vacc, Men Y, (N=160) |
3
|
| titer ≥ 1:4, post-vacc, Men Y, (N=167) |
56
|
| Title | Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 175 | 153 |
| Prevaccination (month 12) (N=174, 152) |
2.11
|
2.29
|
| Postvaccination (month 13) (N=175,153) |
22
|
31
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMTMenACWY/GMTMenC > 0.5). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMTMenACWY/GMTMenC > 0.5). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|
| Arm/Group Description | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 172 |
| prevacc, Men A (N=171) |
1.99
|
| postvacc Men A (N=172) |
10
|
| prevacc, Men W (N=168) |
2.12
|
| postvacc Men W (N=170) |
14
|
| prevacc, Men Y (N=160) |
1.92
|
| postvacc Men Y (N=167) |
7.05
|
| Title | Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y |
|---|---|
| Description | The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 167 | 153 |
| prevacc, Men A (N=159,23) |
3.4
|
2
|
| postvacc Men A (N=166,23) |
75
|
2.22
|
| prevacc, Men C (N=161,152) |
23
|
2.29
|
| postvacc, Men C (N=167,153) |
249
|
31
|
| prevacc, Men W (N=157,23) |
14
|
1.71
|
| postvacc, Men W (N=165,22) |
213
|
2
|
| prevacc, Men Y (N=156,23) |
11
|
1.76
|
| postvacc, Men Y (N=163,22) |
156
|
1.93
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 . | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMTMenACWY/GMTMenjugate > 0.5). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 10 | |
| Confidence Interval |
(2-Sided) 95% 8.43 to 13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (GMTMenACWY/GMTMenjugate > 0.5). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 8.1 | |
| Confidence Interval |
(2-Sided) 95% 6.35 to 10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) |
|---|---|
| Description | The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed. For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration. Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL. Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8. HepB (HBV): primary endpoint ELISA >=10mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 168 | 173 | 152 |
| Anti-Diphtheria Toxin ≥ 0.1 IU/mL N= (168,173,152) |
100
|
100
|
100
|
| Anti-Diphtheria Toxin ≥ 1.0 IU/mL N= (168,173,152) |
99
|
98
|
98
|
| Anti-Tetanus Toxin ≥ 0.1 IU/mL N= (168,173,152) |
100
|
100
|
100
|
| Anti-Tetanus Toxin ≥ 1.0 IU/mL N= (168,173,152) |
96
|
96
|
97
|
| FHA ELISA N=(160,169,152) |
97
|
91
|
96
|
| PRN ELISA N=(160,169,152) |
99
|
98
|
99
|
| PT ELISA N=(159,165,151) |
97
|
95
|
97
|
| polio 1 N=(157,161,148) |
100
|
100
|
99
|
| polio 2 N=157,(161,148) |
100
|
99
|
100
|
| polio 3 N=(146,151,143) |
100
|
100
|
100
|
| Hep B N=(157,161,147) |
99
|
99
|
99
|
| Anti-PRP (HIB) ≥ 0.15 μg/mL N=(168,173,151) |
100
|
100
|
100
|
| Anti-PRP (HIB) ≥ 1.0 μg/mL N=(168,173,151) |
100
|
98
|
99
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -2 | |
| Confidence Interval |
(2-Sided) 95% -6 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 9
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -3 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -2 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) |
|---|---|
| Description | To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age. Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL. |
| Time Frame | 1 month postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 163 | 168 | 150 |
| PNC 4 N=(168,150) |
83
|
82
|
87
|
| PNC 6B N=(168,149) |
92
|
91
|
97
|
| PNC 9V N=(168,150) |
90
|
89
|
93
|
| PNC 14 N=(167,150) |
99
|
99
|
99
|
| PNC 18C N=(168,150) |
71
|
76
|
86
|
| PNC 19 F N=(168,150) |
81
|
80
|
90
|
| PNC 23 F N=(168,150) |
88
|
89
|
94
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -13 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -6 | |
| Confidence Interval |
(2-Sided) 95% -12 to -1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -11 to 2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -10 | |
| Confidence Interval |
(2-Sided) 95% -19 to -2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -10 | |
| Confidence Interval |
(2-Sided) 95% -17 to -2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -12 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -12 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -11 to 0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| 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 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -1 | |
| Confidence Interval |
(2-Sided) 95% -4 to 3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -15 | |
| Confidence Interval |
(2-Sided) 95% -24 to -6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -9 | |
| Confidence Interval |
(2-Sided) 95% -17 to -1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -6 | |
| Confidence Interval |
(2-Sided) 95% -13 to 0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C |
|---|---|
| Description | Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia). |
| Time Frame | 1 month postvaccination and 6-18 months postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set (persistence subgroup). |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 17 | 14 | 13 |
| hSBA ≥ 1:8, postvacc, Men C. N=(17,14,13) |
100
|
86
|
92
|
| hSBA ≥ 1:8, perisistence, Men C. N=(17,14,13) |
71
|
64
|
54
|
| hSBA ≥ 1:4, postvacc, Men C. N=(17,14,13) |
100
|
93
|
100
|
| hSBA ≥ 1:4, persistence, Men C. N=(17,14,13) |
76
|
71
|
77
|
| Title | Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y |
|---|---|
| Description | Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia). |
| Time Frame | 1 month postvaccination 6-18 months postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set (persistence subset). |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 17 | 14 |
| hSBA ≥ 1:8, postvacc, Men A (N=17,14) |
88
|
42
|
| hSBA ≥ 1:8, persistence, Men A (N=16,14) |
31
|
7
|
| hSBA ≥ 1:4, post-vacc, Men A (N=17,12) |
100
|
50
|
| hSBA ≥ 1:4, persistence, Men A (N=16,14) |
38
|
14
|
| hSBA ≥ 1:8, postvacc, Men W (N=17,12) |
100
|
67
|
| hSBA ≥ 1:8, persistence, Men W (N=16,14) |
75
|
71
|
| hSBA ≥ 1:4, postvacc, Men W (N=17,13) |
86
|
0
|
| hSBA ≥ 1:4, persistence, Men W (N=16,14) |
88
|
71
|
| hSBA ≥ 1:8, postvacc, Men Y (N=17,12) |
100
|
33
|
| hSBA ≥ 1:8, persistence, Men Y (N=14,14) |
79
|
79
|
| hSBA ≥ 1:4, postvacc, Men Y (N=17,12) |
100
|
50
|
| hSBA ≥ 1:4, persistence, Men Y (N=14,14) |
86
|
93
|
| Title | Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C |
|---|---|
| Description | Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia). |
| Time Frame | 1 month postvaccination and 6-18 months postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set (subjects enrolled in Australia). |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC(1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 17 | 14 | 13 |
| Month 13 |
241
|
36
|
30
|
| 6 - 18 months after month 12 |
15
|
12
|
8.95
|
| Title | Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y |
|---|---|
| Description | Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia). |
| Time Frame | 6-18 months postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set (only for subjects enrolled in Australia). |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 17 | 14 |
| Month 12, Ser A (N= 17, 12) |
47
|
6.69
|
| 6 - 18 months after Month 12, Ser A (N=16,14) |
4.41
|
2.78
|
| Month 12, Ser W (N= 17, 12) |
180
|
13
|
| 6 - 18 months after Month 12, Ser W (N=16,14) |
20
|
20
|
| Month 12, Ser Y (N= 17, 12) |
151
|
5.13
|
| 6 - 18 months after Month 12, Ser Y (N=14,14) |
22
|
16
|
| Title | Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 156 | 157 | 145 |
| rSBA titer ≥ 1:8, prevacc (N=140,140,139) |
72
|
4
|
1
|
| rSBA titer ≥ 1:8, postvacc (N=156,157,145) |
98
|
92
|
97
|
| rSBA titer ≥ 1:128, prevacc (N=140,140,139) |
31
|
1
|
0
|
| rSBA titer ≥ 1:128, postvacc (N=156,157,145) |
92
|
75
|
88
|
| four fold rise (N=132,140,139) |
86
|
91
|
96
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 71 | |
| Confidence Interval |
(2-Sided) 95% 63 to 78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -3 to 6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -2 to 7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -11 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage difference |
| Estimated Value | 31 | |
| Confidence Interval |
(2-Sided) 95% 24 to 39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| 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 to 4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 4 | |
| Confidence Interval |
(2-Sided) 95% -3 to 11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -13 | |
| Confidence Interval |
(2-Sided) 95% -22 to -5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -10 | |
| Confidence Interval |
(2-Sided) 95% -17 to -4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | MenC (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -5 | |
| Confidence Interval |
(2-Sided) 95% -11 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 76 | 83 |
| rSBA titer ≥ 1:128, Men A |
100
|
98
|
| rSBA titer ≥ 1:128, Men W |
96
|
93
|
| rSBA titer ≥ 1:128, Men Y |
89
|
86
|
| rSBA titer ≥ 1:8, Men A |
100
|
98
|
| rSBA titer ≥ 1:8, Men W |
100
|
95
|
| rSBA titer ≥ 1:8, Men Y |
97
|
88
|
| Four Fold Rise of rSBA titer, Men A |
75
|
95
|
| Four Fold Rise of rSBA titer, Men W |
95
|
95
|
| Four Fold Rise of rSBA titer, Men Y |
91
|
87
|
| Title | Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 156 | 157 | 145 |
| GMT, prevacc (N=140,140,139) |
26
|
2.22
|
2.03
|
| GMT, postvacc (N=156,157,145) |
353
|
131
|
266
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM197 (1dose) + Concomitant Vaccines, MenC (1dose) + Concomitant Vaccines |
|---|---|---|
| Comments | For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | (PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.33 | |
| Confidence Interval |
(2-Sided) 95% 0.96 to 1.83 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y |
|---|---|
| Description | Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y. |
| Time Frame | 1 month postvaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP set. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines |
|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 76 | 83 |
| GMT, prevacc, Men A (N=73,82) |
281
|
6.83
|
| GMT, postvacc, Men A |
3136
|
3258
|
| GMT, prevacc, Men W (N=59,75) |
20
|
2.32
|
| GMT, postvacc, Men W |
708
|
1306
|
| GMT, prevacc, Men Y (N=32,49) |
22
|
2.4
|
| GMT, postvacc, Men Y (N=76,81) |
574
|
598
|
| Title | Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination |
|---|---|
| Description | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups. safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups |
| Time Frame | From day 1 to day 7 postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data. |
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines |
|---|---|---|---|
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. |
| Measure Participants | 195 | 192 | 179 |
| Any Local N=(195,192,179) |
130
|
131
|
135
|
| Tenderness (MenACWY-CRM197/MenC)N=(194,192,178) |
57
|
65
|
44
|
| Erythema (MenACWY-CRM197/MenC) N=(194,192,178) |
94
|
62
|
64
|
| Induration (MenACWY-CRM197/MenC) N=(194,192,178) |
53
|
24
|
43
|
| Tenderness (DTPa-IPV-HepB-Hib) N=(189,190,176) |
62
|
83
|
73
|
| Erythema (DTPa-IPV-HepB-Hib)B N=(189,190,176) |
80
|
81
|
96
|
| Induration (DTPa-IPV-HepB-Hib) N=(189,190,176) |
62
|
66
|
81
|
| Tenderness (PCV7) N=(189,190,176) |
58
|
68
|
60
|
| Erythema (PCV7) N=(189,190,176) |
71
|
68
|
77
|
| Induration (PCV7) N=(189,190,176) |
50
|
50
|
59
|
| Any Systemic reactions N=(195,192,179) |
173
|
149
|
150
|
| Change in eating habits N=(189, 191,177) |
62
|
66
|
49
|
| Sleepiness N=(191,191,179) |
93
|
99
|
94
|
| Persistent crying N=(189,191,177) |
77
|
93
|
76
|
| Irritability N=(191,191,179) |
67
|
68
|
73
|
| Vomiting N=(191,191,179) |
10
|
18
|
16
|
| Diarrhoea N=(191,191,179) |
26
|
41
|
42
|
| Rash N=(191,191,179) |
7
|
17
|
7
|
| Fever ≥ 38.5C N=(191,192,179) |
54
|
62
|
50
|
| Others N=(195,192,179) |
64
|
62
|
62
|
| Analgesic-Antipyretic medication N=(191,192,179) |
58
|
62
|
62
|
Adverse Events
| Time Frame | Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Data collected from one site were not included in the data analysis for outcome measures and the AE section. | |||||
| Arm/Group Title | MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines | |||
| Arm/Group Description | Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. | |||
All Cause Mortality |
||||||
| MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/195 (6.7%) | 19/192 (9.9%) | 12/179 (6.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Lymphadenitis | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Gastrointestinal disorders | ||||||
| Amphthous stomatitis | 1/195 (0.5%) | 0/192 (0%) | 0/179 (0%) | |||
| Diarrhoea | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Intussusception | 1/195 (0.5%) | 0/192 (0%) | 0/179 (0%) | |||
| Stomatitis | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Vomiting | 0/195 (0%) | 2/192 (1%) | 0/179 (0%) | |||
| General disorders | ||||||
| Hyperpyrexia | 1/195 (0.5%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Immune system disorders | ||||||
| Food Allergy | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Infections and infestations | ||||||
| Appendicitis | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Bronchitis | 2/195 (1%) | 3/192 (1.6%) | 0/179 (0%) | |||
| Croup infectious | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Febrile infection | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Gastroenteritis | 3/195 (1.5%) | 4/192 (2.1%) | 4/179 (2.2%) | |||
| Influenza | 1/195 (0.5%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Malaria | 1/195 (0.5%) | 0/192 (0%) | 0/179 (0%) | |||
| Otitis media | 0/195 (0%) | 1/192 (0.5%) | 3/179 (1.7%) | |||
| Pneumonia | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Pneumonia respiratory syncytial viral | 1/195 (0.5%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Sepsis | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Tonsillitis | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Upper respiratory tract infection | 1/195 (0.5%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Viral infection | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Injury, poisoning and procedural complications | ||||||
| Accidental exposure | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Concussion | 1/195 (0.5%) | 2/192 (1%) | 0/179 (0%) | |||
| Contusion | 1/195 (0.5%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Thermal burn | 0/195 (0%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 2/195 (1%) | 0/192 (0%) | 1/179 (0.6%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neuroblastoma | 0/195 (0%) | 1/192 (0.5%) | 0/179 (0%) | |||
| Nervous system disorders | ||||||
| Febrile convulsion | 0/195 (0%) | 1/192 (0.5%) | 1/179 (0.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 2/195 (1%) | 0/192 (0%) | 0/179 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| MenACWY-CRM197 (2dose) + Concomitant Vaccines | MenACWY-CRM197 (1dose) + Concomitant Vaccines | MenC (1dose) + Concomitant Vaccines | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 192/195 (98.5%) | 184/192 (95.8%) | 170/179 (95%) | |||
| Eye disorders | ||||||
| Conjunctivitis | 36/195 (18.5%) | 15/192 (7.8%) | 18/179 (10.1%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 54/195 (27.7%) | 44/192 (22.9%) | 44/179 (24.6%) | |||
| Enteritis | 13/195 (6.7%) | 4/192 (2.1%) | 5/179 (2.8%) | |||
| Teething | 21/195 (10.8%) | 6/192 (3.1%) | 7/179 (3.9%) | |||
| Vomiting | 38/195 (19.5%) | 24/192 (12.5%) | 19/179 (10.6%) | |||
| General disorders | ||||||
| Injection site erythema | 110/195 (56.4%) | 102/192 (53.1%) | 110/179 (61.5%) | |||
| Injection site induration | 86/195 (44.1%) | 82/192 (42.7%) | 104/179 (58.1%) | |||
| Injection site pain | 90/195 (46.2%) | 97/192 (50.5%) | 84/179 (46.9%) | |||
| Irritability | 85/195 (43.6%) | 68/192 (35.4%) | 73/179 (40.8%) | |||
| Pyrexia | 127/195 (65.1%) | 111/192 (57.8%) | 102/179 (57%) | |||
| Infections and infestations | ||||||
| Bronchitis | 47/195 (24.1%) | 29/192 (15.1%) | 29/179 (16.2%) | |||
| Gastroenteritis | 22/195 (11.3%) | 14/192 (7.3%) | 12/179 (6.7%) | |||
| Nasopharyngitis | 19/195 (9.7%) | 14/192 (7.3%) | 14/179 (7.8%) | |||
| Otitis media | 33/195 (16.9%) | 22/192 (11.5%) | 21/179 (11.7%) | |||
| Rhinitis | 24/195 (12.3%) | 7/192 (3.6%) | 8/179 (4.5%) | |||
| Upper respiratory tract infection | 67/195 (34.4%) | 31/192 (16.1%) | 29/179 (16.2%) | |||
| Viral infection | 38/195 (19.5%) | 26/192 (13.5%) | 26/179 (14.5%) | |||
| Nervous system disorders | ||||||
| Crying | 100/195 (51.3%) | 93/192 (48.4%) | 76/179 (42.5%) | |||
| Somnolence | 126/195 (64.6%) | 99/192 (51.6%) | 94/179 (52.5%) | |||
| Psychiatric disorders | ||||||
| Eating disorder | 87/195 (44.6%) | 66/192 (34.4%) | 49/179 (27.4%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 25/195 (12.8%) | 11/192 (5.7%) | 10/179 (5.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis Diaper | 24/195 (12.3%) | 20/192 (10.4%) | 9/179 (5%) | |||
| Rash | 28/195 (14.4%) | 24/192 (12.5%) | 7/179 (3.9%) | |||
Limitations/Caveats
GCP compliance issues were identified at one site, data collected for this site were not used in this data posting.
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:
NCT00667602
Other Study ID Numbers:
- V59P22
- 2007-004754-82
First Posted:
Apr 28, 2008
Last Update Posted:
Nov 7, 2013
Last Verified:
Sep 1, 2013