Infections, Meningococcal
Conditions
Keywords
hepatitis B, meningococcal vaccine, pertussis, Prophylaxis diphtheria, meningococcal serogroups A and C diseases, tetanus, Haemophilus influenzae type b
Brief summary
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY full dose stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY small dose stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC. Blood samples will be drawn from subjects as follows: * prior to and one month after the full dose of the Mencevax™ ACWY vaccine. * prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
Interventions
BIOLOGICALTritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
BIOLOGICALHiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
BIOLOGICALMencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 15 and 24 months of age at the time of vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV). * Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478). * History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. * Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures including febrile seizures in infancy. * Acute disease at the time of enrolment. * Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). | Antibody cut-offs were higher than or equal to (≥) 1:128 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-rSBA-MenA, C Antibody Titers | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. | Antibody titers were expressed as Geometric Mean Titers (GMTs) |
| Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. | Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL). |
| Anti-PSA, Anti-PSC Antibody Concentrations | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs | Prior to the Mencevax ACWY vaccination at 24-30 Months of age | The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL). |
| Anti-HBs Concentrations | Prior to the Mencevax ACWY vaccination at 24-30 Months of age | Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. | Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128 |
| Number of Subjects With Solicited Local Symptoms | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age | Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade. |
| Number of Subjects With Solicited General Symptoms | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever \[≥ 38 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | From Day 0 at months 15-24 of age to study end at Months 25-31 of age | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From 15-24 Months of age up to Months 25-31 of age | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Vaccine Response for rSBA-Men A, C | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). | Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer \< 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA \> 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. | 203 |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. | 93 |
| Total | 296 |
Baseline characteristics
| Characteristic | Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Total |
|---|---|---|---|
| Age, Continuous | 24.2 Months STANDARD_DEVIATION 0.68 | 24.1 Months STANDARD_DEVIATION 0.4 | 24.17 Months STANDARD_DEVIATION 0.61 |
| Sex: Female, Male Female | 94 Participants | 42 Participants | 136 Participants |
| Sex: Female, Male Male | 109 Participants | 51 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 125 / 203 | 59 / 93 |
| serious Total, serious adverse events | 6 / 203 | 1 / 93 |
Outcome results
Primary
Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies
Antibody cut-offs were higher than or equal to (≥) 1:128
Time frame: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).
Population: The analyses were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | rSBA-MenA ≥1:128 | 116 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | rSBA-MenC ≥1:128 | 192 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | rSBA-MenA ≥1:128 | 66 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | rSBA-MenC ≥1:128 | 53 Subjects |
Secondary
Anti-HBs Concentrations
Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Prior to the Mencevax ACWY vaccination at 24-30 Months of age
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-HBs Concentrations | 251.1 mIU/mL |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-HBs Concentrations | 279.6 mIU/mL |
Secondary
Anti-PSA, Anti-PSC Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Time frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSC (M25-31) | 35.13 µg/mL |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSC (M24-30) | 0.72 µg/mL |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSA (M24-30) | 0.42 µg/mL |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSA (M25-31) | 32.54 µg/mL |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSC (M25-31) | 20.83 µg/mL |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSA (M25-31) | 6.94 µg/mL |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSC (M24-30) | 0.17 µg/mL |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-PSA, Anti-PSC Antibody Concentrations | anti-PSA (M24-30) | 0.20 µg/mL |
Secondary
Anti-rSBA-MenA, C Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs)
Time frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenA (M24-30) | 551.9 Titers |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenA (M25-31) | 2018.9 Titers |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenC (M24-30) | 120.6 Titers |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenC (M25-31) | 11024.4 Titers |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenC (M25-31) | 437.2 Titers |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenA (M24-30) | 469.1 Titers |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenC (M24-30) | 15.5 Titers |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Anti-rSBA-MenA, C Antibody Titers | rSBA-MenA (M25-31) | 2108.1 Titers |
Secondary
Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs
The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).
Time frame: Prior to the Mencevax ACWY vaccination at 24-30 Months of age
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs | 164 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs | 59 Subjects |
Secondary
Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values
Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).
Time frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 0.3 µg/mL (M24-30) | 105 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 0.3 µg/mL (M25-31) | 192 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 2 µg/mL (M24-30) | 19 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 2 µg/mL (M25-31) | 188 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 0.3 µg/mL (M24-30) | 165 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 0.3 µg/mL (M25-31) | 192 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 2 µg/mL (M24-30) | 23 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 2 µg/mL (M25-31) | 192 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 2 µg/mL (M25-31) | 67 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 0.3 µg/mL (M24-30) | 12 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 0.3 µg/mL (M24-30) | 5 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 0.3 µg/mL (M25-31) | 68 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 2 µg/mL (M24-30) | 0 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 2 µg/mL (M24-30) | 1 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSC ≥ 0.3 µg/mL (M25-31) | 69 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | anti-PSA ≥ 2 µg/mL (M25-31) | 55 Subjects |
Secondary
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128
Time frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:128 (M24-30) | 157 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:8 (M24-30) | 164 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:8 (M25-31) | 116 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:8 (M24-30) | 166 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:8 (M25-31) | 192 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:128 (M24-30) | 98 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:8 (M25-31) | 61 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:8 (M24-30) | 22 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:8 (M24-30) | 56 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenC ≥1:128 (M24-30) | 16 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:8 (M25-31) | 66 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | rSBA-MenA ≥1:128 (M24-30) | 55 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From 15-24 Months of age up to Months 25-31 of age
Population: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever \[≥ 38 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade.
Time frame: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age
Population: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 23 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 32 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 20 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any fever (rectal) | 38 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any fever (rectal) | 15 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 7 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 13 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 13 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.
Time frame: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age
Population: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 58 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 78 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 48 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 34 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 38 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 28 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Time frame: From Day 0 at months 15-24 of age to study end at Months 25-31 of age
Population: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 10 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 9 Subjects |
Secondary
Number of Subjects With Vaccine Response for rSBA-Men A, C
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer \< 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA \> 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.
Time frame: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).
Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Vaccine Response for rSBA-Men A, C | rSBA-MenA, Total | 42 Subjects |
| Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Number of Subjects With Vaccine Response for rSBA-Men A, C | rSBA-MenC, Total | 175 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Vaccine Response for rSBA-Men A, C | rSBA-MenA, Total | 26 Subjects |
| Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Number of Subjects With Vaccine Response for rSBA-Men A, C | rSBA-MenC, Total | 44 Subjects |