Trial Outcomes & Findings for Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study (NCT NCT00291343)
NCT ID: NCT00291343
Last Updated: 2018-06-06
Results Overview
Antibody cut-offs were higher than or equal to (≥) 1:128
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
296 participants
Primary outcome timeframe
1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
93
|
|
Overall Study
COMPLETED
|
203
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Baseline characteristics by cohort
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 Participants
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.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.2 Months
STANDARD_DEVIATION 0.68 • n=93 Participants
|
24.1 Months
STANDARD_DEVIATION 0.40 • n=4 Participants
|
24.17 Months
STANDARD_DEVIATION 0.61 • n=27 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
160 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Antibody cut-offs were higher than or equal to (≥) 1:128
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=192 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=67 Participants
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.
|
|---|---|---|
|
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
|
66 Subjects
|
|
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
|
53 Subjects
|
SECONDARY outcome
Timeframe: 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.
Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=192 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=67 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenA ≥1:8 (M24-30)
|
164 Subjects
|
56 Subjects
|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenA ≥1:8 (M25-31)
|
116 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenA ≥1:128 (M24-30)
|
157 Subjects
|
55 Subjects
|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenC ≥1:8 (M24-30)
|
166 Subjects
|
22 Subjects
|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenC ≥1:8 (M25-31)
|
192 Subjects
|
61 Subjects
|
|
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
rSBA-MenC ≥1:128 (M24-30)
|
98 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: 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.
Antibody titers were expressed as Geometric Mean Titers (GMTs)
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=192 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=67 Participants
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.
|
|---|---|---|
|
Anti-rSBA-MenA, C Antibody Titers
rSBA-MenA (M25-31)
|
2018.9 Titers
Interval 1778.0 to 2292.3
|
2108.1 Titers
Interval 1733.4 to 2563.9
|
|
Anti-rSBA-MenA, C Antibody Titers
rSBA-MenC (M24-30)
|
120.6 Titers
Interval 99.3 to 146.5
|
15.5 Titers
Interval 9.4 to 25.6
|
|
Anti-rSBA-MenA, C Antibody Titers
rSBA-MenC (M25-31)
|
11024.4 Titers
Interval 9394.5 to 12937.0
|
437.2 Titers
Interval 269.6 to 708.9
|
|
Anti-rSBA-MenA, C Antibody Titers
rSBA-MenA (M24-30)
|
551.9 Titers
Interval 459.6 to 662.6
|
469.1 Titers
Interval 320.3 to 687.0
|
SECONDARY outcome
Timeframe: 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.
Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=192 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=69 Participants
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.
|
|---|---|---|
|
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
|
12 Subjects
|
|
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
|
68 Subjects
|
|
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
|
1 Subjects
|
|
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
|
55 Subjects
|
|
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
|
5 Subjects
|
|
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
|
69 Subjects
|
|
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
|
0 Subjects
|
|
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
|
67 Subjects
|
SECONDARY outcome
Timeframe: 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.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=192 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=69 Participants
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.
|
|---|---|---|
|
Anti-PSA, Anti-PSC Antibody Concentrations
anti-PSC (M25-31)
|
35.13 µg/mL
Interval 31.55 to 39.11
|
20.83 µg/mL
Interval 16.6 to 26.15
|
|
Anti-PSA, Anti-PSC Antibody Concentrations
anti-PSA (M24-30)
|
0.42 µg/mL
Interval 0.36 to 0.49
|
0.20 µg/mL
Interval 0.17 to 0.24
|
|
Anti-PSA, Anti-PSC Antibody Concentrations
anti-PSA (M25-31)
|
32.54 µg/mL
Interval 27.79 to 38.1
|
6.94 µg/mL
Interval 4.96 to 9.71
|
|
Anti-PSA, Anti-PSC Antibody Concentrations
anti-PSC (M24-30)
|
0.72 µg/mL
Interval 0.64 to 0.82
|
0.17 µg/mL
Interval 0.15 to 0.19
|
SECONDARY outcome
Timeframe: Prior to the Mencevax ACWY vaccination at 24-30 Months of agePopulation: 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.
The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=174 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=66 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs
|
164 Subjects
|
59 Subjects
|
SECONDARY outcome
Timeframe: Prior to the Mencevax ACWY vaccination at 24-30 Months of agePopulation: 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.
Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=174 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=66 Participants
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.
|
|---|---|---|
|
Anti-HBs Concentrations
|
251.1 mIU/mL
Interval 185.0 to 340.7
|
279.6 mIU/mL
Interval 162.5 to 481.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=180 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=61 Participants
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.
|
|---|---|---|
|
Number of Subjects With Vaccine Response for rSBA-Men A, C
rSBA-MenA, Total
|
42 Subjects
|
26 Subjects
|
|
Number of Subjects With Vaccine Response for rSBA-Men A, C
rSBA-MenC, Total
|
175 Subjects
|
44 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of agePopulation: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 Participants
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.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain
|
58 Subjects
|
34 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling
|
48 Subjects
|
28 Subjects
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness
|
78 Subjects
|
38 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of agePopulation: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever \[≥ 38 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade.
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 Participants
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.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness
|
23 Subjects
|
7 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability
|
32 Subjects
|
13 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of appetite
|
20 Subjects
|
13 Subjects
|
|
Number of Subjects With Solicited General Symptoms
Any fever (rectal)
|
38 Subjects
|
15 Subjects
|
SECONDARY outcome
Timeframe: From Day 0 at months 15-24 of age to study end at Months 25-31 of agePopulation: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
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.
Outcome measures
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 Participants
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.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
10 Subjects
|
9 Subjects
|
SECONDARY outcome
Timeframe: From 15-24 Months of age up to Months 25-31 of agePopulation: The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.
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/Hib-MenAC +Mencevax ACWY Group
n=203 Participants
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 Participants
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.
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|---|---|---|
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Number of Subjects With Serious Adverse Events (SAEs)
|
6 Subjects
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1 Subjects
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Adverse Events
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
Serious events: 6 serious events
Other events: 125 other events
Deaths: 0 deaths
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 participants at risk
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 participants at risk
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.
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|---|---|---|
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Nervous system disorders
Febrile convulsion
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Diarrhoea infectious
|
0.99%
2/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Amoebiasis
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Infections and infestations
Ascariasis
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Nervous system disorders
Convulsion
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.49%
1/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
0.00%
0/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
1.1%
1/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
Other adverse events
| Measure |
Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group
n=203 participants at risk
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.
|
Tritanrix-HepB/Hiberix+Mencevax ACWY Group
n=93 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
28.6%
58/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
36.6%
34/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
Redness
|
38.4%
78/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
40.9%
38/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
Swelling
|
23.6%
48/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
30.1%
28/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
DROWSINESS
|
11.3%
23/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
7.5%
7/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
IRRITABILITY
|
15.8%
32/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
14.0%
13/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
LOSS OF APPETITE
|
9.9%
20/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
14.0%
13/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
|
General disorders
FEVER
|
18.7%
38/203 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
16.1%
15/93 • SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
|
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