Trial Outcomes & Findings for Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects (NCT NCT00317109)
NCT ID: NCT00317109
Last Updated: 2018-06-06
Results Overview
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Tritanrix-HepB/Hiberix Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
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|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
|
Overall Study
COMPLETED
|
81
|
84
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Tritanrix-HepB/Hiberix Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Migated/moved from study area
|
1
|
0
|
Baseline Characteristics
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Baseline characteristics by cohort
| Measure |
Tritanrix-HepB/Hiberix Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Total
n=168 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
Months at TRITANRIX™-HEPB/HIBERIX™ booster
|
16.5 Months
STANDARD_DEVIATION 1.02 • n=93 Participants
|
16.5 Months
STANDARD_DEVIATION 1.02 • n=4 Participants
|
16.5 Months
STANDARD_DEVIATION 1.02 • n=27 Participants
|
|
Age, Continuous
Months at MENCEVAX™ booster
|
24.5 Months
STANDARD_DEVIATION 0.92 • n=93 Participants
|
24.6 Months
STANDARD_DEVIATION 1.04 • n=4 Participants
|
24.55 Months
STANDARD_DEVIATION 0.98 • n=27 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
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|---|---|---|
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Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
rSBA-MenA [N=65,60]
|
65 Subjects
|
59 Subjects
|
|
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
rSBA-MenC [N=59,66]
|
30 Subjects
|
66 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=67 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenA ≥1:8 (M24-30) [N=58,53]
|
55 Subjects
|
50 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenA ≥1:8 (M25-31) [N=65,60]
|
65 Subjects
|
60 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenA ≥1:128 (M24-30) [N=58,53]
|
54 Subjects
|
48 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenC ≥1:8 (M24-30) [N=67,61]
|
10 Subjects
|
42 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenC ≥1:8 (M25-31) [N=59,66]
|
53 Subjects
|
66 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenC ≥1:128 (M24-30) [N=67,61]
|
4 Subjects
|
27 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenW-135 ≥1:8 (M24-30) [N=67,63]
|
18 Subjects
|
20 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenW-135 ≥1:8 (M25-31) [N=64,66]
|
49 Subjects
|
44 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenW-135 ≥1:128 (M24-30) [N=67,63]
|
13 Subjects
|
11 Subjects
|
|
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
rSBA-MenW-135 ≥1:128 (M25-31) [N=64,66]
|
45 Subjects
|
37 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody titers were expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=67 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenA (M25-31) [N=65,60]
|
1871.7 Titers
Interval 1515.2 to 2311.9
|
1562.0 Titers
Interval 1252.9 to 1947.2
|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenC (M24-30) [N=67,61]
|
6.7 Titers
Interval 4.9 to 9.1
|
50.7 Titers
Interval 30.7 to 83.5
|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenC (M25-31) [N=59,66]
|
141.3 Titers
Interval 89.2 to 223.9
|
5251.6 Titers
Interval 3662.5 to 7530.2
|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenW-135 (M24-30) [N=67,63]
|
11.1 Titers
Interval 7.2 to 17.1
|
13.7 Titers
Interval 8.3 to 22.5
|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenA (M24-30) [N=58,53]
|
503.8 Titers
Interval 346.6 to 732.1
|
509.9 Titers
Interval 326.9 to 795.3
|
|
Anti-rSBA-MenA, C, W-135 Antibody Titers
rSBA-MenW-135 (M25-31) [N=64,66]
|
159.4 Titers
Interval 91.5 to 277.6
|
92.8 Titers
Interval 50.6 to 170.0
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSA ≥ 0.3 µg/mL (M24-30) [N=63,61]
|
8 Subjects
|
10 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSA ≥ 0.3 µg/mL (M25-31) [N=65,65]
|
62 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSA ≥ 2 µg/mL (M24-30) [N=63,61]
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSA ≥ 2 µg/mL (M25-31) [N=65,65]
|
48 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSC ≥ 0.3 µg/mL (M24-30) [N=61,64]
|
6 Subjects
|
33 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSC ≥ 0.3 µg/mL (M25-31) [N=65,66]
|
65 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSC ≥ 2 µg/mL (M24-30) [N=61,64]
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
anti-PSC ≥ 2 µg/mL (M25-31) [N=65,66]
|
64 Subjects
|
65 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=65 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Anti-PSA and Anti-PSC Antibody Concentrations
anti-PSA (M25-31) [N=65,65]
|
6.61 µg/mL
Interval 4.27 to 10.22
|
22.39 µg/mL
Interval 16.11 to 31.1
|
|
Anti-PSA and Anti-PSC Antibody Concentrations
anti-PSC (M24-30) [N=61,64]
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.35 µg/mL
Interval 0.27 to 0.44
|
|
Anti-PSA and Anti-PSC Antibody Concentrations
anti-PSC (M25-31) [N=65,66]
|
15.70 µg/mL
Interval 12.54 to 19.65
|
35.10 µg/mL
Interval 27.4 to 44.96
|
|
Anti-PSA and Anti-PSC Antibody Concentrations
anti-PSA (M24-30) [N=63,61]
|
0.18 µg/mL
Interval 0.16 to 0.2
|
0.19 µg/mL
Interval 0.16 to 0.21
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations were ≥ 0.3 µg/mL.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=64 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
anti-PSW (M24-30) [N=61,62]
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
anti-PSW (M25-31) [N=64,66]
|
64 Subjects
|
64 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=64 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Anti-PSW Antibody Concentrations
anti-PSW (M24-30) [N=61,62]
|
0.15 µg/mL
Interval 0.15 to 0.15
|
0.16 µg/mL
Interval 0.14 to 0.18
|
|
Anti-PSW Antibody Concentrations
anti-PSW (M25-31) [N=64,66]
|
4.89 µg/mL
Interval 3.68 to 6.5
|
5.19 µg/mL
Interval 3.63 to 7.4
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccinePopulation: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
|
63 Subjects
|
65 Subjects
|
SECONDARY outcome
Timeframe: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccinePopulation: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=66 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Anti-HBs Antibody Concentrations
|
722.0 mIU/mL
Interval 456.2 to 1142.8
|
713.1 mIU/mL
Interval 438.2 to 1160.5
|
SECONDARY outcome
Timeframe: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)Population: The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre \< 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=64 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=62 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
rSBA-MenA, Total [N=56,47]
|
26 Subjects
|
21 Subjects
|
|
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
rSBA-MenC, Total [N=59,60]
|
41 Subjects
|
56 Subjects
|
|
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
rSBA-MenW-135, Total [N=64,62]
|
41 Subjects
|
32 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccinePopulation: The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Fever
|
33 Subjects
|
29 Subjects
|
SECONDARY outcome
Timeframe: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccinePopulation: The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=80 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=82 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symtoms
Any Pain
|
21 Subjects
|
25 Subjects
|
|
Number of Subjects With Solicited Local Symtoms
Any Redness
|
20 Subjects
|
16 Subjects
|
|
Number of Subjects With Solicited Local Symtoms
Any Swelling
|
13 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccinePopulation: The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=80 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=83 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness
|
14 Subjects
|
12 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Fever
|
8 Subjects
|
5 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability
|
15 Subjects
|
12 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of appetite
|
13 Subjects
|
18 Subjects
|
SECONDARY outcome
Timeframe: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccinePopulation: The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=82 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
10 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: From Months 15-18 and up to Months 25-31 post vaccinationPopulation: The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Tritanrix-HepB/Hiberix Group
n=82 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 Participants
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Subjects
|
1 Subjects
|
Adverse Events
Tritanrix-HepB/Hiberix Group
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Tritanrix-HepB/Hiberix-Mencevax AC Group
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tritanrix-HepB/Hiberix Group
n=84 participants at risk；n=82 participants at risk
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 participants at risk
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
1.2%
1/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
0.00%
0/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
0.00%
0/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
1/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
0.00%
0/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
Infections and infestations
Tonsillitis
|
1.2%
1/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
0.00%
0/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
1.2%
1/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
Other adverse events
| Measure |
Tritanrix-HepB/Hiberix Group
n=84 participants at risk；n=82 participants at risk
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
Tritanrix-HepB/Hiberix-Mencevax AC Group
n=84 participants at risk
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix-Mencevax AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix-HepB/Hiberix vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
5/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
4.8%
4/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Pain
|
25.0%
21/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
30.5%
25/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Redness
|
23.8%
20/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
19.5%
16/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Swelling
|
15.5%
13/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
13.4%
11/82 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Drowsiness
|
16.7%
14/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
14.5%
12/83 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Fever/(Rectally) (°C)
|
9.5%
8/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
6.0%
5/83 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Irritability
|
17.9%
15/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
14.5%
12/83 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
|
General disorders
Loss of appetite
|
15.5%
13/84 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
21.7%
18/83 • Fever during the 4-day (Days 0-3) post Tritanrix-HepB/Hiberix vaccination; Solicited local/general during the 4-day (Days 0-3) and AEs during the 31-day (Days 0-30) after Mencevax ACW vaccination; SAEs from Months 15-18 and up to Months 25-31.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER