Trial Outcomes & Findings for Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine (NCT NCT01449812)
NCT ID: NCT01449812
Last Updated: 2018-06-06
Results Overview
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
831 participants
Primary outcome timeframe
Before the booster vaccination (At Day 0)
Results posted on
2018-06-06
Participant Flow
6 subjects did not receive vaccination.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Infanrix+Hib/Poliorix 1 Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
272
|
273
|
280
|
|
Overall Study
COMPLETED
|
270
|
273
|
279
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Infanrix+Hib/Poliorix 1 Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Baseline characteristics by cohort
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Total
n=825 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.5 Months
STANDARD_DEVIATION 0.93 • n=99 Participants
|
19.4 Months
STANDARD_DEVIATION 0.91 • n=107 Participants
|
19.5 Months
STANDARD_DEVIATION 0.97 • n=206 Participants
|
19.47 Months
STANDARD_DEVIATION 0.94 • n=7 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
377 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
448 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian-Chinese heritage
|
272 Participants
n=99 Participants
|
273 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
825 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=279 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D
|
241 Participants
|
250 Participants
|
234 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T
|
269 Participants
|
271 Participants
|
275 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=279 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
0.175 IU/mL
Interval 0.163 to 0.188
|
0.189 IU/mL
Interval 0.176 to 0.202
|
0.154 IU/mL
Interval 0.142 to 0.166
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
0.45 IU/mL
Interval 0.423 to 0.478
|
0.509 IU/mL
Interval 0.481 to 0.54
|
0.38 IU/mL
Interval 0.359 to 0.404
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
|
226 Participants
|
234 Participants
|
241 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
|
2.275 µg/mL
Interval 1.856 to 2.788
|
2.674 µg/mL
Interval 2.193 to 3.26
|
2.413 µg/mL
Interval 2.006 to 2.904
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-polio 1
|
259 Participants
|
267 Participants
|
270 Participants
|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-polio 2
|
248 Participants
|
261 Participants
|
250 Participants
|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-polio 3
|
254 Participants
|
259 Participants
|
257 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 1
|
72.3 Titers
Interval 62.4 to 83.7
|
95.7 Titers
Interval 82.5 to 111.0
|
77.2 Titers
Interval 67.0 to 89.0
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 2
|
57.3 Titers
Interval 47.0 to 70.0
|
63.6 Titers
Interval 53.5 to 75.5
|
42.6 Titers
Interval 35.7 to 50.8
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 3
|
71.3 Titers
Interval 60.1 to 84.7
|
79.9 Titers
Interval 66.4 to 96.2
|
60.6 Titers
Interval 51.2 to 71.8
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PT
|
260 Participants
|
263 Participants
|
260 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-FHA
|
262 Participants
|
267 Participants
|
262 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Anti-PRN
|
260 Participants
|
265 Participants
|
267 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT
|
10.3 EL.U/mL
Interval 9.6 to 11.1
|
12.2 EL.U/mL
Interval 11.3 to 13.1
|
10.4 EL.U/mL
Interval 9.6 to 11.2
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA
|
12.8 EL.U/mL
Interval 11.9 to 13.7
|
14.3 EL.U/mL
Interval 13.4 to 15.2
|
12.4 EL.U/mL
Interval 11.5 to 13.4
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN
|
9.2 EL.U/mL
Interval 8.8 to 9.7
|
9.7 EL.U/mL
Interval 9.2 to 10.1
|
9 EL.U/mL
Interval 8.5 to 9.5
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D
|
235 Participants
|
245 Participants
|
228 Participants
|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Anti-T
|
264 Participants
|
266 Participants
|
268 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D
|
265 Participants
|
268 Participants
|
270 Participants
|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Anti-T
|
266 Participants
|
268 Participants
|
272 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
0.174 IU/mL
Interval 0.162 to 0.187
|
0.189 IU/mL
Interval 0.176 to 0.202
|
0.154 IU/mL
Interval 0.142 to 0.166
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
0.455 IU/mL
Interval 0.429 to 0.483
|
0.511 IU/mL
Interval 0.482 to 0.542
|
0.38 IU/mL
Interval 0.357 to 0.403
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
1.341 IU/mL
Interval 1.239 to 1.451
|
1.504 IU/mL
Interval 1.377 to 1.643
|
1.227 IU/mL
Interval 1.134 to 1.326
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
4.862 IU/mL
Interval 4.614 to 5.124
|
4.927 IU/mL
Interval 4.693 to 5.173
|
4.371 IU/mL
Interval 4.161 to 4.591
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
|
221 Participants
|
229 Participants
|
234 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against PRP
|
264 Participants
|
268 Participants
|
271 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
|
2.308 µg/mL
Interval 1.878 to 2.836
|
2.743 µg/mL
Interval 2.245 to 3.352
|
2.407 µg/mL
Interval 1.993 to 2.908
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
|
35.178 µg/mL
Interval 30.617 to 40.418
|
49.023 µg/mL
Interval 43.649 to 55.058
|
27.682 µg/mL
Interval 24.251 to 31.598
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
Anti-Polio 1
|
253 Participants
|
262 Participants
|
263 Participants
|
|
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
Anti-Polio 2
|
243 Participants
|
256 Participants
|
244 Participants
|
|
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
Anti-Polio 3
|
249 Participants
|
254 Participants
|
250 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=265 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-Polio 1
|
265 Participants
|
268 Participants
|
273 Participants
|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-Polio 2
|
265 Participants
|
268 Participants
|
273 Participants
|
|
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Anti-Polio 3
|
265 Participants
|
268 Participants
|
273 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 1
|
72 Titers
Interval 62.0 to 83.7
|
96.3 Titers
Interval 82.8 to 112.0
|
75.9 Titers
Interval 65.7 to 87.6
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 2
|
56.5 Titers
Interval 46.2 to 69.0
|
64.1 Titers
Interval 53.8 to 76.4
|
41.9 Titers
Interval 35.0 to 50.0
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 3
|
72.6 Titers
Interval 61.1 to 86.3
|
79.4 Titers
Interval 65.8 to 95.8
|
60.3 Titers
Interval 50.8 to 71.6
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=265 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 1
|
3512.2 Titers
Interval 3159.7 to 3904.1
|
3410.9 Titers
Interval 3081.7 to 3775.4
|
3386.8 Titers
Interval 3078.0 to 3726.6
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 2
|
1931.2 Titers
Interval 1721.7 to 2166.2
|
2237.9 Titers
Interval 2001.6 to 2502.1
|
1886.1 Titers
Interval 1679.6 to 2117.9
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 3
|
5237.8 Titers
Interval 4671.8 to 5872.3
|
5438.5 Titers
Interval 4846.8 to 6102.4
|
5141.2 Titers
Interval 4650.1 to 5684.2
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-PT
|
254 Participants
|
258 Participants
|
253 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-FHA
|
256 Participants
|
262 Participants
|
255 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-PRN
|
254 Participants
|
260 Participants
|
260 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-PRN
|
266 Participants
|
268 Participants
|
273 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-PT
|
266 Participants
|
268 Participants
|
273 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Anti-FHA
|
266 Participants
|
268 Participants
|
273 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT
|
10.3 EL.U/mL
Interval 9.5 to 11.1
|
12.2 EL.U/mL
Interval 11.3 to 13.1
|
10.3 EL.U/mL
Interval 9.5 to 11.2
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA
|
12.7 EL.U/mL
Interval 11.8 to 13.6
|
14.3 EL.U/mL
Interval 13.4 to 15.2
|
12.3 EL.U/mL
Interval 11.4 to 13.3
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN
|
9.2 EL.U/mL
Interval 8.7 to 9.6
|
9.7 EL.U/mL
Interval 9.2 to 10.2
|
9 EL.U/mL
Interval 8.5 to 9.5
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Anti-PT
|
138.5 EL.U/mL
Interval 132.0 to 145.3
|
146.2 EL.U/mL
Interval 139.7 to 153.0
|
126.8 EL.U/mL
Interval 120.4 to 133.5
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Anti-FHA
|
124.6 EL.U/mL
Interval 119.2 to 130.2
|
124 EL.U/mL
Interval 119.2 to 129.0
|
120.8 EL.U/mL
Interval 115.3 to 126.6
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Anti-PRN
|
57.3 EL.U/mL
Interval 55.6 to 59.1
|
59.9 EL.U/mL
Interval 58.1 to 61.8
|
57.2 EL.U/mL
Interval 55.3 to 59.1
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=266 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=268 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-PT
|
266 Participants
|
268 Participants
|
272 Participants
|
|
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-FHA
|
266 Participants
|
268 Participants
|
272 Participants
|
|
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Anti-PRN
|
239 Participants
|
230 Participants
|
244 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=270 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=279 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain
|
73 Participants
|
74 Participants
|
76 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness
|
19 Participants
|
15 Participants
|
19 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling
|
16 Participants
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Outcome measures
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=270 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=279 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness
|
38 Participants
|
50 Participants
|
38 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability
|
78 Participants
|
81 Participants
|
72 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of appetite
|
67 Participants
|
73 Participants
|
69 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever
|
102 Participants
|
105 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.
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 |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
16 Participants
|
13 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 up to Month 1)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.
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 |
Infanrix+Hib/Poliorix 1 Group
n=272 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 Participants
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Infanrix+Hib/Poliorix 1 Group
Serious events: 1 serious events
Other events: 157 other events
Deaths: 0 deaths
Infanrix+Hib/Poliorix 2 Group
Serious events: 0 serious events
Other events: 164 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.37%
1/272 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
0.00%
0/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
0.00%
0/280 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Bronchopneumonia
|
0.37%
1/272 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
0.00%
0/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
0.00%
0/280 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
Other adverse events
| Measure |
Infanrix+Hib/Poliorix 1 Group
n=272 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Infanrix+Hib/Poliorix 2 Group
n=273 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
Control Group
n=280 participants at risk
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
|
|---|---|---|---|
|
General disorders
Pain
|
27.0%
73/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
27.1%
74/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
27.2%
76/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Redness
|
7.0%
19/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
5.5%
15/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
5.7%
16/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Swelling
|
5.9%
16/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
3.7%
10/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
5.0%
14/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Drowsiness
|
14.1%
38/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
18.3%
50/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
13.6%
38/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Irritability
|
28.9%
78/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
29.7%
81/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
25.8%
72/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Loss of appetite
|
24.8%
67/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
26.7%
73/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
24.7%
69/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Fever
|
37.8%
102/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
38.5%
105/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
|
32.6%
91/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
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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