Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine (NCT NCT01309646)
NCT ID: NCT01309646
Last Updated: 2019-11-27
Results Overview
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
At Month 5
Results posted on
2019-11-27
Participant Flow
Initially, a total of 454 subjects were enrolled in the study but 3 subjects had withdrawn from the study. Therefore, a total of 451 subjects were enrolled in the study.
Participant milestones
| Measure |
Infanrix-IPV+Hib Group
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
227
|
|
Overall Study
COMPLETED
|
224
|
227
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Baseline characteristics by cohort
| Measure |
Infanrix-IPV+Hib Group
n=224 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 weeks
STANDARD_DEVIATION 1.10 • n=5 Participants
|
8.8 weeks
STANDARD_DEVIATION 1.09 • n=7 Participants
|
8.8 weeks
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
224 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
213 Participants
|
217 Participants
|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
213 Participants
|
217 Participants
|
PRIMARY outcome
Timeframe: At Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=212 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=216 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-Polio 1
|
212 Participants
|
216 Participants
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-Polio 2
|
204 Participants
|
211 Participants
|
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-polio 3
|
197 Participants
|
197 Participants
|
PRIMARY outcome
Timeframe: At Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
|
213 Participants
|
217 Participants
|
PRIMARY outcome
Timeframe: At Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Anti-PT
|
54.2 EL.U/mL
Interval 50.4 to 58.3
|
56 EL.U/mL
Interval 51.8 to 60.5
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Anti-FHA
|
125 EL.U/mL
Interval 115.4 to 135.4
|
134.2 EL.U/mL
Interval 124.2 to 145.0
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Anti-PRN
|
125.8 EL.U/mL
Interval 116.0 to 136.5
|
133.4 EL.U/mL
Interval 123.0 to 144.6
|
SECONDARY outcome
Timeframe: At Month 0 and Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-PT at Month 5
|
213 Participants
|
217 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-FHA at Month 5
|
213 Participants
|
217 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-PRN at Month 5
|
213 Participants
|
217 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-PT at Month 0
|
27 Participants
|
34 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-FHA at Month 0
|
170 Participants
|
178 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Anti-PRN at Month 0
|
25 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-PT
|
3.0 EL.U/mL
Interval 2.8 to 3.2
|
3.1 EL.U/mL
Interval 2.9 to 3.3
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-FHA
|
10.5 EL.U/mL
Interval 9.3 to 12.0
|
11.7 EL.U/mL
Interval 10.3 to 13.3
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-PRN
|
2.9 EL.U/mL
Interval 2.7 to 3.0
|
3.1 EL.U/mL
Interval 2.8 to 3.3
|
SECONDARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
64 Participants
|
76 Participants
|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
29 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D at Month 0
|
0.058 IU/mL
Interval 0.055 to 0.061
|
0.060 IU/mL
Interval 0.056 to 0.064
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D at Month 5
|
8.096 IU/mL
Interval 7.52 to 8.717
|
8.692 IU/mL
Interval 8.125 to 9.298
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T at Month 0
|
0.081 IU/mL
Interval 0.072 to 0.09
|
0.091 IU/mL
Interval 0.08 to 0.103
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T at Month 5
|
10.259 IU/mL
Interval 9.654 to 10.902
|
12.421 IU/mL
Interval 11.599 to 13.301
|
SECONDARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=211 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=216 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-Polio 1
|
104 Participants
|
89 Participants
|
|
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-Polio 2
|
119 Participants
|
108 Participants
|
|
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Anti-polio 3
|
41 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=212 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=216 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 1 at Month 0
|
9.5 titers
Interval 8.3 to 11.0
|
9.4 titers
Interval 8.0 to 11.0
|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 1 at Month 5
|
328.8 titers
Interval 289.8 to 373.1
|
372.7 titers
Interval 323.8 to 428.9
|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 2 at Month 0
|
10.8 titers
Interval 9.4 to 12.5
|
8.8 titers
Interval 7.7 to 9.9
|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 2 at Month 5
|
340.6 titers
Interval 295.4 to 392.6
|
400.2 titers
Interval 347.6 to 460.7
|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 3 at Month 0
|
5.5 titers
Interval 5.0 to 6.1
|
4.9 titers
Interval 4.5 to 5.3
|
|
Titres for Anti-polio Types 1, 2 and 3.
Anti-polio 3 at Month 5
|
377.7 titers
Interval 322.3 to 442.6
|
465.3 titers
Interval 390.3 to 554.7
|
SECONDARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
|
91 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Concentrations of Anti-PRP Antibodies.
Anti-PRP at Month 0
|
0.165 µg/mL
Interval 0.143 to 0.191
|
0.219 µg/mL
Interval 0.184 to 0.26
|
|
Concentrations of Anti-PRP Antibodies.
Anti-PRP at Month 5
|
8.456 µg/mL
Interval 7.283 to 9.819
|
18.700 µg/mL
Interval 16.353 to 21.384
|
SECONDARY outcome
Timeframe: At Month 5Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=213 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=217 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Anti-PRN
|
213 Participants
|
216 Participants
|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Anti-PT
|
211 Participants
|
215 Participants
|
|
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Anti-FHA
|
207 Participants
|
207 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=224 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Pain
|
143 Participants
|
146 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Redness
|
177 Participants
|
167 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Swelling
|
130 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=224 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms.
Any Drowsiness
|
153 Participants
|
147 Participants
|
|
Number of Subjects With Any Solicited General Symptoms.
Any Irritability/Fussiness
|
181 Participants
|
182 Participants
|
|
Number of Subjects With Any Solicited General Symptoms.
Any Loss of appetite
|
120 Participants
|
103 Participants
|
|
Number of Subjects With Any Solicited General Symptoms.
Temperature ≥ 37.5°C
|
83 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
Infanrix-IPV+Hib Group
n=224 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
|
130 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 to Month 7)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
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-IPV+Hib Group
n=224 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 Participants
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
|
25 Participants
|
21 Participants
|
Adverse Events
Infanrix-IPV+Hib Group
Serious events: 25 serious events
Other events: 218 other events
Deaths: 0 deaths
Infanrix IPV Group
Serious events: 21 serious events
Other events: 220 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix-IPV+Hib Group
n=224 participants at risk
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
Infanrix IPV Group
n=227 participants at risk
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
3.1%
7/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
2.2%
5/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
2.6%
6/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Pneumonia
|
2.2%
5/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
4/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Viral infection
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
1.3%
3/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Bronchitis
|
0.89%
2/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.89%
2/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Croup infectious
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Cystitis
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Gastrointestinal disorders
Enteritis
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Gastrointestinal disorders
Intussusception
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Meningitis
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Pyelonephritis acute
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.45%
1/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.00%
0/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Infections and infestations
Sepsis
|
0.00%
0/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
0.44%
1/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
|
Other adverse events
| Measure |
Infanrix-IPV+Hib Group
n=224 participants at risk
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
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Infanrix IPV Group
n=227 participants at risk
Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
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Infections and infestations
Nasopharyngitis
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16.5%
37/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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12.8%
29/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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Infections and infestations
Upper respiratory tract infection
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15.2%
34/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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12.8%
29/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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Gastrointestinal disorders
Diarrhoea
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12.9%
29/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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4.4%
10/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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Infections and infestations
Bronchitis
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6.2%
14/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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6.2%
14/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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Infections and infestations
Bronchiolitis
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6.2%
14/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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5.7%
13/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Pain
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63.8%
143/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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64.3%
146/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Redness
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79.0%
177/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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73.6%
167/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Swelling
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58.0%
130/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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53.3%
121/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Drowsiness
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68.3%
153/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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64.8%
147/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Irritability/Fussiness
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80.8%
181/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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80.2%
182/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Loss of appetite
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53.6%
120/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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45.4%
103/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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General disorders
Temperature (Tympanic)
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37.1%
83/224 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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35.7%
81/227 • SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.
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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