3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00129116
Collaborator
(none)
388
26
5
9.5
14.9
1.6
Study Details
Study Description
Brief Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
Study Design
Study Type:
Interventional
Actual Enrollment
:
388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
Study Start Date
:
Mar 1, 2003
Actual Primary Completion Date
:
Dec 1, 2003
Actual Study Completion Date
:
Dec 16, 2003
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Menhibrix F1/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Names:
|
| Experimental: Menhibrix F2/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Names:
|
| Experimental: Menhibrix F3/Infanrix-penta Group Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Names:
|
| Experimental: Menitorix/Infanrix-penta Group Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Biological: Hib-MenC-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Names:
|
| Active Comparator: Menjugate/Infanrix-hexa Group Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Biological: Menjugate ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix hexa ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [One month after dose 3 (at study Month 3 - primary phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [One month after dose 3 (at study Month 3 - primary phase)]
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [One month after dose 3 (at study Month 3 - primary phase)]
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [One month after the booster vaccination (at study Month 1 - booster phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [One month after the booster vaccination (at study Month 1 - booster phase)]
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [One month after the booster vaccination (at study Month 1 - booster phase)]
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Secondary Outcome Measures
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)]
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)]
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [Prior to the booster vaccination (at study Month 0 - booster phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [Prior to the booster vaccination (at study Month 0 - booster phase)]
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [Prior to the booster vaccination (at study Month 0 - booster phase)]
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
- rSBA-MenC Antibody Titres [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Titres are expressed as geometric mean titres (GMTs)
- rSBA-MenY Antibody Titres [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Titres are expressed as geometric mean titres (GMTs)
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
- Anti-PRP Antibody Concentrations [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
- Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
- Anti-PSC Antibody Concentrations [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Anti-PSY Antibody Concentrations [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Anti-tetanus Antibody Concentrations [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
- Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
- Number of Seroprotected Subjects for Anti-tetanus Antibodies [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
- Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) [Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)]
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
- Anti-PRP Antibody Concentrations [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
- rSBA-MenC Antibody Titres [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Titres are expressed as geometric mean titres (GMTs)
- rSBA-MenY Antibody Titres [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Titres are expressed as geometric mean titres (GMTs)
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
- Anti-PSC Antibody Concentrations [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Anti-PSY Antibody Concentrations [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
- Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
- Anti-T Antibody Concentrations [Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
- Anti-diphtheria Antibody Concentrations [One month after the third dose (at study Month 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
- Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations [One month after the third dose (at study Month 3 - primary phase)]
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
- Anti-poliovirus Types 1, 2, 3 Antibody Titres [One month after the third dose (at study Month 3 - primary phase)]
Titres are expressed as geometric mean titres (GMTs)
- Number of Seroprotected Subjects for Anti-diphtheria Antibodies [One month after the third dose (at study Month 3 - primary phase)]
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
- Number of Seroprotected Subjects for Anti-hepatitis B Antibodies [One month after the third dose (at study Month 3 - primary phase)]
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies [One month after the third dose (at study Month 3 - primary phase)]
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
- Number of Subjects With Vaccine Response to PT, FHA and PRN [One month after the third dose (at study Month 3 - primary phase)]
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
- Number of Subjects With Solicited Local Symptoms [During the 8-day (Day 0-7) follow-up period (during the primary phase)]
Solicited local symptoms assessed were pain, redness and swelling.
- Number of Subjects With Solicited General Symptoms [During the 8-day (Day 0-7) follow-up period (during the primary phase)]
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
- Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31-day (Day 0-30) follow-up period (during the primary phase)]
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [Over the full course of the primary phase (up to study Month 3 - primary phase)]
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
- Number of Subjects With Solicited Local Symptoms [During the 8-day (Day 0-7) follow-up period (during the booster phase)]
Solicited local symptoms assessed were pain, redness and swelling.
- Number of Subjects With Solicited General Symptoms [During the 8-day (Day 0-7) follow-up period (during the booster phase)]
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
- Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31-day (Day 0-30) follow-up period (during the booster phase)]
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [Over the full course of the booster phase (up to study Month 1 - booster phase)]
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Weeks
to 12 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Exclusion Criteria:
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Asse | Belgium | 1730 | |
| 2 | GSK Investigational Site | Drongen | Belgium | 9031 | |
| 3 | GSK Investigational Site | Gent | Belgium | 9000 | |
| 4 | GSK Investigational Site | Maldegem | Belgium | 9990 | |
| 5 | GSK Investigational Site | Merelbeke | Belgium | 9820 | |
| 6 | GSK Investigational Site | Oudenaarde | Belgium | 9700 | |
| 7 | GSK Investigational Site | Sint-Amandsberg | Belgium | 9040 | |
| 8 | GSK Investigational Site | Cham | Bayern | Germany | 93413 |
| 9 | GSK Investigational Site | Kaufering | Bayern | Germany | 86916 |
| 10 | GSK Investigational Site | Muenchen | Bayern | Germany | 80939 |
| 11 | GSK Investigational Site | Muenchen | Bayern | Germany | 81675 |
| 12 | GSK Investigational Site | Noerdlingen | Bayern | Germany | 86720 |
| 13 | GSK Investigational Site | Olching | Bayern | Germany | 82140 |
| 14 | GSK Investigational Site | Niedernhausen | Hessen | Germany | 65527 |
| 15 | GSK Investigational Site | Detmold | Nordrhein-Westfalen | Germany | 32756 |
| 16 | GSK Investigational Site | Kirchlengern | Nordrhein-Westfalen | Germany | 32278 |
| 17 | GSK Investigational Site | Loehne | Nordrhein-Westfalen | Germany | 32584 |
| 18 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04178 |
| 19 | GSK Investigational Site | Bredstedt | Schleswig-Holstein | Germany | 25821 |
| 20 | GSK Investigational Site | Flensburg | Schleswig-Holstein | Germany | 24937 |
| 21 | GSK Investigational Site | Flensburg | Schleswig-Holstein | Germany | 24943 |
| 22 | GSK Investigational Site | Berlin | Germany | 10315 | |
| 23 | GSK Investigational Site | Berlin | Germany | 12627 | |
| 24 | GSK Investigational Site | Berlin | Germany | 13355 | |
| 25 | GSK Investigational Site | Berlin | Germany | 14197 | |
| 26 | GSK Investigational Site | Hamburg | Germany | 22307 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. Review.
- Habermehl P, Leroux-Roels G, Sänger R, Mächler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00129116
Other Study ID Numbers:
- 792014/003
- 100381
First Posted:
Aug 11, 2005
Last Update Posted:
Aug 27, 2018
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The study is divided in two phases: Primary phase: 3-dose primary vaccination at 2, 3 and 4 months of age = study Months 0, 1, 2. Data were collected up to 1 month after the 3rd dose (study Month 3) Booster phase: booster dose at 12-18 months of age = study Month 0. Data were collected up to 1 month after the booster dose (study Month 1) |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Period Title: Primary Phase | |||||
| STARTED | 78 | 77 | 78 | 78 | 77 |
| COMPLETED | 76 | 73 | 77 | 77 | 76 |
| NOT COMPLETED | 2 | 4 | 1 | 1 | 1 |
| Period Title: Primary Phase | |||||
| STARTED | 47 | 42 | 44 | 44 | 44 |
| COMPLETED | 45 | 42 | 44 | 44 | 43 |
| NOT COMPLETED | 2 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Total of all reporting groups |
| Overall Participants | 78 | 77 | 78 | 78 | 77 | 388 |
| Age (Weeks) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Weeks] |
8.5
(1.69)
|
8.8
(1.72)
|
8.7
(1.55)
|
8.3
(1.63)
|
9.0
(1.65)
|
8.7
(1.65)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
31
39.7%
|
37
48.1%
|
44
56.4%
|
33
42.3%
|
40
51.9%
|
185
47.7%
|
| Male |
47
60.3%
|
40
51.9%
|
34
43.6%
|
45
57.7%
|
37
48.1%
|
203
52.3%
|
Outcome Measures
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| Time Frame | One month after dose 3 (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 67 | 67 | 70 | 74 | 71 |
| Number [Subjects] |
66
|
66
|
69
|
73
|
57
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | One month after dose 3 (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 70 | 67 | 71 | 74 | 71 |
| Number [Subjects] |
70
|
67
|
71
|
74
|
71
|
| Title | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | One month after dose 3 (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 66 | 71 | 74 | 71 |
| Number [Subjects] |
67
|
64
|
70
|
16
|
14
|
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| Time Frame | One month after the booster vaccination (at study Month 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 39 | 39 | 39 | 40 | 39 |
| Number [Subjects] |
39
|
39
|
39
|
40
|
39
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | One month after the booster vaccination (at study Month 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 40 | 39 | 42 | 41 | 39 |
| Number [Subjects] |
40
|
39
|
42
|
41
|
39
|
| Title | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | One month after the booster vaccination (at study Month 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 40 | 39 | 42 | 40 | 39 |
| Number [Subjects] |
40
|
39
|
42
|
13
|
14
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 64 | 70 | 73 | 71 |
| Number [Subjects] |
4
|
6
|
4
|
6
|
3
|
| Title | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 70 | 63 | 71 | 73 | 71 |
| Number [Subjects] |
11
|
10
|
16
|
10
|
17
|
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| Time Frame | Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 63 | 71 | 73 | 71 |
| Number [Subjects] |
13
|
8
|
8
|
9
|
3
|
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL) |
| Time Frame | Prior to the booster vaccination (at study Month 0 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 36 |
| Number [Subjects] |
26
|
28
|
27
|
32
|
11
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenC antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | Prior to the booster vaccination (at study Month 0 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 42 | 39 | 41 | 41 | 38 |
| Number [Subjects] |
38
|
38
|
38
|
39
|
36
|
| Title | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
|---|---|
| Description | rSBA-MenY antibody titre cut-off value assessed was ≥1:8 |
| Time Frame | Prior to the booster vaccination (at study Month 0 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 37 |
| Number [Subjects] |
35
|
31
|
36
|
11
|
15
|
| Title | rSBA-MenC Antibody Titres |
|---|---|
| Description | Titres are expressed as geometric mean titres (GMTs) |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 70 | 67 | 71 | 74 | 71 |
| rSBA-MenC [Month 0] (N=69,64,70,73,71) |
4.7
|
4.8
|
4.6
|
4.7
|
4.5
|
| rSBA-MenC [Month 3] (N=70,67,71,74,71) |
1005.8
|
1029.8
|
906.9
|
871.0
|
3557.6
|
| Title | rSBA-MenY Antibody Titres |
|---|---|
| Description | Titres are expressed as geometric mean titres (GMTs) |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 70 | 66 | 71 | 74 | 71 |
| rSBA-MenY [Month 0] (N=70,63,71,73,71) |
5.9
|
5.9
|
7.4
|
5.9
|
7.7
|
| rSBA-MenY [Month 3] (N=69,66,71,74,71) |
470.7
|
437.1
|
635.3
|
9.3
|
7.5
|
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL) |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-PRP >= 0.15 µg/mL [Mth 0] (N=69,63,71,73,71) |
51
|
42
|
50
|
50
|
50
|
| Anti-PRP >= 0.15 µg/mL [Mth 3] (N=67,67,70,74,71) |
67
|
67
|
70
|
74
|
71
|
| Title | Anti-PRP Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-PRP [Month 0] (N=69,63,71,73,71) |
0.289
|
0.243
|
0.255
|
0.243
|
0.217
|
| Anti-PRP [Month 3] (N=67,67,70,74,71) |
9.014
|
9.485
|
8.075
|
10.435
|
2.595
|
| Title | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
|---|---|
| Description | Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 66 | 71 | 74 | 71 |
| Anti-PSC [Month 0] (N=69,63,71,74,71) |
7
|
12
|
7
|
7
|
10
|
| Anti-PSC [Month 3] (N=69,66,70,74,71) |
69
|
66
|
70
|
74
|
71
|
| Title | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
|---|---|
| Description | Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 66 | 71 | 74 | 71 |
| Anti-PSY [Month 0] (N=69,64,71,73,71) |
7
|
6
|
12
|
15
|
12
|
| Anti-PSY [Month 3] (N=69,66,70,74,71) |
69
|
66
|
70
|
6
|
4
|
| Title | Anti-PSC Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 66 | 71 | 74 | 71 |
| Anti-PSC [Month 0] (N=69,63,71,74,71) |
0.18
|
0.20
|
0.18
|
0.18
|
0.18
|
| Anti-PSC [Month 3] (N=69,66,70,74,71) |
21.70
|
27.26
|
19.02
|
21.08
|
38.49
|
| Title | Anti-PSY Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 66 | 71 | 74 | 71 |
| Anti-PSY [Month 0] (N=69,64,71,73,71) |
0.19
|
0.18
|
0.20
|
0.22
|
0.20
|
| Anti-PSY [Month 3] (N=69,66,70,74,71) |
26.86
|
37.02
|
23.57
|
0.19
|
0.17
|
| Title | Anti-tetanus Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL). |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-tetanus [Month 0] (N=69,63,71,73,71) |
0.433
|
0.485
|
0.523
|
0.436
|
0.379
|
| Anti-tetanus [Month 3] (N=68,67,70,74,71) |
3.057
|
3.254
|
2.972
|
3.151
|
1.656
|
| Title | Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre. |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-PT [Month 0] (N=67,62,68,70,69) |
3.4
|
3.1
|
3.7
|
3.3
|
3.1
|
| Anti-PT [Month 3] (N=67,63,69,74,69) |
53.9
|
52.9
|
50.8
|
55.4
|
41.3
|
| Anti-FHA [Month 0] (N=69,63,69,72,70) |
6.5
|
6.0
|
7.3
|
9.9
|
7.0
|
| Anti-FHA [Month 3] (N=67,63,69,74,71) |
83.7
|
91.5
|
89.3
|
92.4
|
74.0
|
| Anti-PRN [Month 0] (N=68,62,71,72,70) |
6.3
|
4.5
|
5.5
|
6.4
|
6.5
|
| Anti-PRN [Month 3] (N=68,67,70,74,71) |
94.2
|
97.1
|
96.2
|
99.1
|
80.2
|
| Title | Number of Seroprotected Subjects for Anti-tetanus Antibodies |
|---|---|
| Description | Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL) |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-tetanus [Month 0] (N=69,63,71,73,71) |
58
|
57
|
60
|
63
|
61
|
| Anti-tetanus [Month 3] (N=68,67,70,74,71) |
68
|
67
|
70
|
74
|
71
|
| Title | Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) |
|---|---|
| Description | Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre. |
| Time Frame | Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 69 | 67 | 71 | 74 | 71 |
| Anti-PT [Month 0] (N=67,62,68,70,69) |
15
|
11
|
18
|
12
|
9
|
| Anti-PT [Month 3] (N=67,63,69,74,69) |
67
|
63
|
69
|
74
|
69
|
| Anti-FHA [Month 0] (N=69,63,69,72,70) |
42
|
37
|
42
|
55
|
45
|
| Anti-FHA [Month 3] (N=67,63,69,74,71) |
67
|
63
|
69
|
74
|
71
|
| Anti-PRN [Month 0] (N=68,62,71,72,70) |
36
|
25
|
37
|
37
|
37
|
| Anti-PRN [Month 3] (N=68,67,70,74,71) |
68
|
67
|
70
|
74
|
71
|
| Title | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). |
|---|---|
| Description | Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL) |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| Anti-PRP >= 0.15 µg/mL Month 0 (N=41,39,42,42,36) |
39
|
38
|
42
|
42
|
36
|
| Anti-PRP >= 0.15 µg/mL Month 1 (N=39,39,39,40,39) |
39
|
39
|
39
|
40
|
39
|
| Title | Anti-PRP Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| Anti-PRP [Month 0] (N=41,39,42,42,36) |
1.306
|
1.591
|
1.414
|
1.764
|
0.607
|
| Anti-PRP [Month 1] (N=39,39,39,40,39) |
36.280
|
32.930
|
34.107
|
47.742
|
24.345
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 |
|---|---|
| Description | rSBA-MenC antibody titre cut-off value assessed was ≥1:128 |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 42 | 39 | 42 | 41 | 39 |
| rSBA-Menc [Month 0] (N=42,39,41,41,38) |
25
|
24
|
22
|
27
|
26
|
| rSBA-Menc [Month 1] (N=40,39,42,41,39) |
40
|
36
|
42
|
40
|
39
|
| Title | Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 |
|---|---|
| Description | rSBA-MenY antibody titre cut-off value assessed was ≥1:128 |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| rSBA-MenY [Month 0] (N=41,39,42,42,37) |
24
|
18
|
23
|
6
|
7
|
| rSBA-MenY [Month 1] (N=40,39,42,40,39) |
40
|
39
|
42
|
6
|
10
|
| Title | rSBA-MenC Antibody Titres |
|---|---|
| Description | Titres are expressed as geometric mean titres (GMTs) |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 42 | 39 | 42 | 41 | 39 |
| rSBA-MenC [Month 0] (N=42,39,41,41,38) |
128.0
|
144.2
|
125.8
|
150.6
|
195.5
|
| rSBA-MenC [Month 1] (N=40,39,42,41,39) |
4762.6
|
2897.7
|
2626.4
|
3226.2
|
11819.3
|
| Title | rSBA-MenY Antibody Titres |
|---|---|
| Description | Titres are expressed as geometric mean titres (GMTs) |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| rSBA-MenY [Month 0] (N=41,39,42,42,37) |
97.2
|
64.0
|
100.9
|
11.0
|
16.1
|
| rSBA-MenY [Month 1] (N=40,39,42,40,39) |
1708.1
|
1313.8
|
1566.0
|
11.7
|
16.5
|
| Title | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
|---|---|
| Description | Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 38 | 38 | 40 | 40 | 39 |
| Anti-PSC [Month 0] (N=38,38,40,40,38) |
38
|
38
|
40
|
40
|
38
|
| Anti-PSC [Month 1] (N=33,33,39,37,39) |
33
|
33
|
39
|
37
|
39
|
| Title | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) |
|---|---|
| Description | Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 38 | 38 | 40 | 40 | 39 |
| Anti-PSC [Month 0] (N=38,38,40,40,38) |
24
|
30
|
28
|
26
|
27
|
| Anti-PSC [Month 1] (N=33,33,39,37,39) |
33
|
33
|
39
|
37
|
39
|
| Title | Anti-PSC Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 38 | 38 | 40 | 40 | 39 |
| Anti-PSC [Month 0] (N=38,38,40,40,38) |
2.57
|
3.23
|
2.53
|
3.08
|
3.17
|
| Anti-PSC [Month 1] (N=33,33,39,37,39) |
32.04
|
28.00
|
19.75
|
27.71
|
64.41
|
| Title | Anti-PSY Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL. |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 42 | 39 | 42 | 42 | 38 |
| Anti-PSY [Month 0] (N=39,39,42,42,38) |
3.72
|
5.25
|
3.96
|
0.16
|
NA
|
| Anti-PSY [Month 1] (N=42,39,41,40,38) |
26.15
|
35.90
|
32.18
|
0.17
|
NA
|
| Title | Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). |
|---|---|
| Description | Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| Anti-tetanus [Month 0] (N=41,39,42,42,38) |
41
|
39
|
42
|
42
|
37
|
| Anti-tetanus [Month 1] (N=39,39,39,40,39) |
39
|
39
|
39
|
40
|
39
|
| Title | Anti-T Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL). |
| Time Frame | Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 41 | 39 | 42 | 42 | 39 |
| Anti-tetanus [Month 0] (N=41,39,42,42,38) |
0.836
|
0.986
|
0.894
|
0.839
|
0.322
|
| Anti-tetanus [Month 1] (N=39,39,39,40,39) |
12.609
|
10.175
|
9.893
|
11.674
|
5.474
|
| Title | Anti-diphtheria Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL. |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 68 | 64 | 69 | 74 | 69 |
| Geometric Mean (95% Confidence Interval) [IU/mL] |
1.016
|
0.927
|
0.980
|
1.012
|
1.904
|
| Title | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
|---|---|
| Description | Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL). |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 62 | 61 | 67 | 72 | 65 |
| Geometric Mean (95% Confidence Interval) [mIU/mL] |
377.9
|
397.0
|
408.9
|
520.5
|
287.3
|
| Title | Anti-poliovirus Types 1, 2, 3 Antibody Titres |
|---|---|
| Description | Titres are expressed as geometric mean titres (GMTs) |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 57 | 55 | 58 | 61 | 56 |
| Anti-poliovirus type 1 (N=57,55,56,61,56) |
275.5
|
242.0
|
216.8
|
305.2
|
282.6
|
| Anti-poliovirus type 2 (N=55,55,58,61,56) |
155.8
|
149.9
|
133.7
|
123.1
|
171.3
|
| Anti-poliovirus type 3 (N=57,55,58,61,56) |
649.0
|
577.2
|
451.7
|
603.6
|
505.7
|
| Title | Number of Seroprotected Subjects for Anti-diphtheria Antibodies |
|---|---|
| Description | Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 68 | 64 | 69 | 74 | 69 |
| Number [Subjects] |
66
|
64
|
69
|
74
|
69
|
| Title | Number of Seroprotected Subjects for Anti-hepatitis B Antibodies |
|---|---|
| Description | Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 62 | 61 | 67 | 72 | 65 |
| Number [Subjects] |
60
|
60
|
66
|
70
|
61
|
| Title | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies |
|---|---|
| Description | Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8 |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 57 | 55 | 58 | 61 | 56 |
| Anti-poliovirus type 1 (N=57,55,56,61,56) |
57
|
55
|
56
|
61
|
55
|
| Anti-poliovirus type 2 (N=55,55,58,61,56) |
55
|
55
|
58
|
59
|
56
|
| Anti-poliovirus type 3 (N=57,55,58,61,56) |
57
|
55
|
58
|
61
|
56
|
| Title | Number of Subjects With Vaccine Response to PT, FHA and PRN |
|---|---|
| Description | Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies. |
| Time Frame | One month after the third dose (at study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 66 | 62 | 70 | 72 | 70 |
| Anti-PT (N=64,58,66,70,68) |
63
|
58
|
64
|
66
|
68
|
| Anti-FHA (N=66,59,67,72,70) |
65
|
58
|
65
|
68
|
70
|
| Anti-PRN (N=66,62,70,72,70) |
61
|
59
|
68
|
63
|
65
|
| Title | Number of Subjects With Solicited Local Symptoms |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. |
| Time Frame | During the 8-day (Day 0-7) follow-up period (during the primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 78 | 77 | 78 | 78 | 77 |
| Pain |
21
|
20
|
22
|
19
|
19
|
| Redness |
35
|
38
|
50
|
32
|
46
|
| Swelling |
31
|
35
|
30
|
27
|
35
|
| Title | Number of Subjects With Solicited General Symptoms |
|---|---|
| Description | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)). |
| Time Frame | During the 8-day (Day 0-7) follow-up period (during the primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 78 | 77 | 78 | 78 | 77 |
| Drowsiness |
39
|
53
|
43
|
37
|
46
|
| Irritability |
44
|
42
|
51
|
47
|
44
|
| Loss of appetite |
24
|
34
|
29
|
33
|
30
|
| Fever (rectal) >= 38.0°C |
25
|
28
|
26
|
28
|
28
|
| Title | Number of Subjects With Unsolicited Adverse Events (AEs) |
|---|---|
| Description | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Time Frame | During the 31-day (Day 0-30) follow-up period (during the primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 78 | 77 | 78 | 78 | 77 |
| Number [Subjects] |
39
|
33
|
35
|
31
|
26
|
| Title | Number of Subjects Reporting Serious Adverse Events (SAEs) |
|---|---|
| Description | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Time Frame | Over the full course of the primary phase (up to study Month 3 - primary phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 78 | 77 | 78 | 78 | 77 |
| Number [Subjects] |
0
|
1
|
2
|
1
|
3
|
| Title | Number of Subjects With Solicited Local Symptoms |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. |
| Time Frame | During the 8-day (Day 0-7) follow-up period (during the booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster Total Vaccinated Cohort included all subjects who received the booster dose. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 47 | 42 | 44 | 44 | 44 |
| Pain |
5
|
10
|
8
|
8
|
9
|
| Redness |
20
|
18
|
22
|
16
|
16
|
| Swelling |
15
|
12
|
12
|
9
|
10
|
| Title | Number of Subjects With Solicited General Symptoms |
|---|---|
| Description | Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)). |
| Time Frame | During the 8-day (Day 0-7) follow-up period (during the booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster Total Vaccinated Cohort included all subjects who received the booster dose. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 47 | 42 | 44 | 44 | 44 |
| Drowsiness |
14
|
18
|
18
|
17
|
18
|
| Irritability |
16
|
18
|
19
|
14
|
17
|
| Loss of appetite |
11
|
16
|
12
|
10
|
14
|
| Fever (rectal) >= 38.0°C |
13
|
10
|
16
|
18
|
16
|
| Title | Number of Subjects With Unsolicited Adverse Events (AEs) |
|---|---|
| Description | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Time Frame | During the 31-day (Day 0-30) follow-up period (during the booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster Total Vaccinated Cohort included all subjects who received the booster dose. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 47 | 42 | 44 | 44 | 44 |
| Number [Subjects] |
7
|
12
|
13
|
12
|
11
|
| Title | Number of Subjects Reporting Serious Adverse Events (SAEs) |
|---|---|
| Description | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Time Frame | Over the full course of the booster phase (up to study Month 1 - booster phase) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Booster Total Vaccinated Cohort included all subjects who received the booster dose. |
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Measure Participants | 47 | 42 | 44 | 44 | 44 |
| Number [Subjects] |
1
|
1
|
0
|
1
|
0
|
Adverse Events
| Time Frame | SAEs: Over the full course of the primary and booster phases (up to Month 3 - primary phase and up to Month 1 - booster phase). Unsolicited AEs: During the 31-day (Days 0-30) follow-up period. Solicited AEs: During the 8-day (Days 0-7) follow-up period | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | |||||
| Arm/Group Description | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. | |||||
All Cause Mortality |
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| Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/78 (1.3%) | 1/77 (1.3%) | 2/78 (2.6%) | 1/78 (1.3%) | 3/77 (3.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 0/78 (0%) | 0/77 (0%) | 1/78 (1.3%) | 0/78 (0%) | 0/77 (0%) | |||||
| Vomiting | 0/78 (0%) | 0/77 (0%) | 1/78 (1.3%) | 0/78 (0%) | 0/77 (0%) | |||||
| Infections and infestations | ||||||||||
| Bronchitis | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 0/78 (0%) | 1/77 (1.3%) | |||||
| Gastroenteritis | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 0/78 (0%) | 1/77 (1.3%) | |||||
| Laryngotracheo bronchitis | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 0/78 (0%) | 1/77 (1.3%) | |||||
| Upper respiratory tract infection | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 1/78 (1.3%) | 0/77 (0%) | |||||
| Urinary tract infection | 0/78 (0%) | 1/77 (1.3%) | 0/78 (0%) | 0/78 (0%) | 0/77 (0%) | |||||
| Gastroenteritis | 1/47 (2.1%) | 0/42 (0%) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) | |||||
| Otitis media | 0/47 (0%) | 0/42 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/44 (0%) | |||||
| Upper respiratory tract infection | 0/47 (0%) | 1/42 (2.4%) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 0/78 (0%) | 1/77 (1.3%) | |||||
| Nervous system disorders | ||||||||||
| Febrile convulsion | 0/47 (0%) | 1/42 (2.4%) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Apnoea | 0/78 (0%) | 0/77 (0%) | 0/78 (0%) | 0/78 (0%) | 1/77 (1.3%) | |||||
Other (Not Including Serious) Adverse Events |
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| Menhibrix F1/Infanrix-penta Group | Menhibrix F2/Infanrix-penta Group | Menhibrix F3/Infanrix-penta Group | Menitorix/Infanrix-penta Group | Menjugate/Infanrix-hexa Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 70/78 (89.7%) | 71/77 (92.2%) | 73/78 (93.6%) | 71/78 (91%) | 70/77 (90.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 3/78 (3.8%) | 1/77 (1.3%) | 2/78 (2.6%) | 4/78 (5.1%) | 2/77 (2.6%) | |||||
| Constipation | 2/78 (2.6%) | 0/77 (0%) | 2/78 (2.6%) | 1/78 (1.3%) | 4/77 (5.2%) | |||||
| General disorders | ||||||||||
| Pain | 21/78 (26.9%) | 20/77 (26%) | 22/78 (28.2%) | 19/78 (24.4%) | 19/77 (24.7%) | |||||
| Redness | 35/78 (44.9%) | 38/77 (49.4%) | 50/78 (64.1%) | 32/78 (41%) | 46/77 (59.7%) | |||||
| Swelling | 31/78 (39.7%) | 35/77 (45.5%) | 30/78 (38.5%) | 27/78 (34.6%) | 35/77 (45.5%) | |||||
| Drowsiness | 39/78 (50%) | 53/77 (68.8%) | 43/78 (55.1%) | 37/78 (47.4%) | 46/77 (59.7%) | |||||
| Irritability | 44/78 (56.4%) | 42/77 (54.5%) | 51/78 (65.4%) | 47/78 (60.3%) | 44/77 (57.1%) | |||||
| Loss of appetite | 24/78 (30.8%) | 34/77 (44.2%) | 29/78 (37.2%) | 33/78 (42.3%) | 30/77 (39%) | |||||
| Fever | 25/78 (32.1%) | 28/77 (36.4%) | 26/78 (33.3%) | 28/78 (35.9%) | 28/77 (36.4%) | |||||
| Pyrexia | 1/78 (1.3%) | 0/77 (0%) | 4/78 (5.1%) | 3/78 (3.8%) | 2/77 (2.6%) | |||||
| Pain | 5/47 (10.6%) | 10/42 (23.8%) | 8/44 (18.2%) | 8/44 (18.2%) | 9/44 (20.5%) | |||||
| Redness | 20/47 (42.6%) | 18/42 (42.9%) | 22/44 (50%) | 16/44 (36.4%) | 16/44 (36.4%) | |||||
| Swelling | 15/47 (31.9%) | 12/42 (28.6%) | 12/44 (27.3%) | 9/44 (20.5%) | 10/44 (22.7%) | |||||
| Drowsiness | 14/47 (29.8%) | 18/42 (42.9%) | 18/44 (40.9%) | 17/44 (38.6%) | 18/44 (40.9%) | |||||
| Irritability | 16/47 (34%) | 18/42 (42.9%) | 19/44 (43.2%) | 14/44 (31.8%) | 17/44 (38.6%) | |||||
| Loss of appetite | 11/47 (23.4%) | 16/42 (38.1%) | 12/44 (27.3%) | 10/44 (22.7%) | 14/44 (31.8%) | |||||
| Fever | 13/47 (27.7%) | 10/42 (23.8%) | 16/44 (36.4%) | 18/44 (40.9%) | 16/44 (36.4%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 11/78 (14.1%) | 6/77 (7.8%) | 4/78 (5.1%) | 8/78 (10.3%) | 6/77 (7.8%) | |||||
| Bronchitis | 6/78 (7.7%) | 4/77 (5.2%) | 2/78 (2.6%) | 3/78 (3.8%) | 3/77 (3.9%) | |||||
| Candidiasis | 6/78 (7.7%) | 3/77 (3.9%) | 4/78 (5.1%) | 2/78 (2.6%) | 3/77 (3.9%) | |||||
| Upper respiratory tract infection | 5/47 (10.6%) | 6/42 (14.3%) | 4/44 (9.1%) | 2/44 (4.5%) | 4/44 (9.1%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Rhinitis | 3/78 (3.8%) | 4/77 (5.2%) | 3/78 (3.8%) | 4/78 (5.1%) | 4/77 (5.2%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Eczema | 3/78 (3.8%) | 1/77 (1.3%) | 5/78 (6.4%) | 1/78 (1.3%) | 4/77 (5.2%) | |||||
| Dermatitis | 0/78 (0%) | 4/77 (5.2%) | 0/78 (0%) | 1/78 (1.3%) | 2/77 (2.6%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00129116
Other Study ID Numbers:
- 792014/003
- 100381
First Posted:
Aug 11, 2005
Last Update Posted:
Aug 27, 2018
Last Verified:
Oct 1, 2016