Trial Outcomes & Findings for Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) (NCT NCT01248884)
NCT ID: NCT01248884
Last Updated: 2018-08-20
Results Overview
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
721 participants
Primary outcome timeframe
At Month 0
Results posted on
2018-08-20
Participant Flow
A total of 721 subjects were enrolled in the study.
Participant milestones
| Measure |
GSK217744 Group 1
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Overall Study
STARTED
|
240
|
242
|
239
|
|
Overall Study
COMPLETED
|
238
|
239
|
238
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
GSK217744 Group 1
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Baseline characteristics by cohort
| Measure |
GSK217744 Group 1
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=242 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=239 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Total
n=721 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.7 Weeks
STANDARD_DEVIATION 1.36 • n=5 Participants
|
9.8 Weeks
STANDARD_DEVIATION 1.29 • n=7 Participants
|
9.7 Weeks
STANDARD_DEVIATION 1.21 • n=5 Participants
|
9.73 Weeks
STANDARD_DEVIATION 1.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
356 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
365 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African heritage /African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / north African heritage
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European heritage
|
144 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
432 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
92 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=200 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=210 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=211 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
154 Participants
|
165 Participants
|
160 Participants
|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
197 Participants
|
206 Participants
|
209 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=214 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=217 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=219 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D
|
214 Participants
|
217 Participants
|
219 Participants
|
|
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T
|
214 Participants
|
217 Participants
|
219 Participants
|
PRIMARY outcome
Timeframe: At Month 0Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=200 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=210 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=210 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PT
|
3.3 EL.U/mL
Interval 3.0 to 3.6
|
3.4 EL.U/mL
Interval 3.1 to 3.7
|
3.1 EL.U/mL
Interval 2.9 to 3.4
|
|
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PRN
|
5.1 EL.U/mL
Interval 4.5 to 5.9
|
4.9 EL.U/mL
Interval 4.3 to 5.5
|
4.9 EL.U/mL
Interval 4.3 to 5.7
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=215 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=217 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=219 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PT
|
57.7 EL.U/mL
Interval 52.9 to 62.9
|
57.5 EL.U/mL
Interval 53.1 to 62.4
|
73.2 EL.U/mL
Interval 67.7 to 79.2
|
|
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PRN
|
76.6 EL.U/mL
Interval 68.1 to 86.3
|
65.7 EL.U/mL
Interval 58.9 to 73.3
|
106.6 EL.U/mL
Interval 96.6 to 117.8
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=214 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=216 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=218 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
|
197 Participants
|
190 Participants
|
193 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Outcome measures
| Measure |
GSK217744 Group 1
n=202 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=205 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=209 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Anti-HBs ≥ 10 mIU/mL (ELISA)
|
197 Participants
|
203 Participants
|
205 Participants
|
|
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Anti-HBs ≥ 100 mIU/mL (ELISA)
|
184 Participants
|
183 Participants
|
196 Participants
|
|
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Anti-HBs ≥ 10 mIU/mL (CLIA)
|
197 Participants
|
201 Participants
|
203 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK217744 Group 1
n=202 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=205 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=209 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL
|
639.5 mIU/mL
Interval 523.6 to 781.2
|
602.6 mIU/mL
Interval 492.1 to 737.9
|
799.0 mIU/mL
Interval 662.2 to 964.0
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Outcome measures
| Measure |
GSK217744 Group 1
n=214 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=217 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=219 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D at Month 0
|
0.292 IU/mL
Interval 0.247 to 0.347
|
0.281 IU/mL
Interval 0.238 to 0.332
|
0.290 IU/mL
Interval 0.245 to 0.343
|
|
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-D at Month 3
|
1.499 IU/mL
Interval 1.367 to 1.644
|
1.704 IU/mL
Interval 1.564 to 1.856
|
1.839 IU/mL
Interval 1.686 to 2.005
|
|
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T at Month 0
|
0.936 IU/mL
Interval 0.832 to 1.053
|
0.920 IU/mL
Interval 0.822 to 1.029
|
0.907 IU/mL
Interval 0.812 to 1.013
|
|
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Anti-T at Month 3
|
1.761 IU/mL
Interval 1.624 to 1.91
|
1.726 IU/mL
Interval 1.597 to 1.865
|
1.947 IU/mL
Interval 1.818 to 2.085
|
SECONDARY outcome
Timeframe: At Months 0 and 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Outcome measures
| Measure |
GSK217744 Group 1
n=215 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=217 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=219 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PT at Month 0
|
33 Participants
|
38 Participants
|
31 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PT at Month 3
|
215 Participants
|
217 Participants
|
218 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PRN at Month 0
|
84 Participants
|
89 Participants
|
76 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Anti-PRN at Month 3
|
214 Participants
|
215 Participants
|
219 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
GSK217744 Group 1
n=214 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=216 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=218 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
|
0.951 µg/mL
Interval 0.793 to 1.142
|
0.730 µg/mL
Interval 0.606 to 0.88
|
1.082 µg/mL
Interval 0.884 to 1.324
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
GSK217744 Group 1
n=108 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=112 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=114 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 1
|
107 Participants
|
112 Participants
|
111 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 3
|
106 Participants
|
105 Participants
|
107 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 4
|
108 Participants
|
112 Participants
|
114 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 5
|
107 Participants
|
109 Participants
|
109 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 6A
|
108 Participants
|
111 Participants
|
112 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 6B
|
97 Participants
|
104 Participants
|
102 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 7F
|
107 Participants
|
111 Participants
|
114 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 9V
|
107 Participants
|
112 Participants
|
113 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 14
|
108 Participants
|
112 Participants
|
114 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 18C
|
106 Participants
|
112 Participants
|
109 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 19A
|
106 Participants
|
112 Participants
|
114 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 19F
|
107 Participants
|
111 Participants
|
114 Participants
|
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Anti- PNE 23F
|
103 Participants
|
104 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
GSK217744 Group 1
n=108 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=112 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=114 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 1
|
1.61 µg /mL
Interval 1.42 to 1.83
|
1.48 µg /mL
Interval 1.32 to 1.67
|
1.58 µg /mL
Interval 1.38 to 1.81
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 3
|
0.91 µg /mL
Interval 0.8 to 1.03
|
0.91 µg /mL
Interval 0.82 to 1.01
|
0.94 µg /mL
Interval 0.84 to 1.05
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 4
|
1.80 µg /mL
Interval 1.61 to 2.03
|
1.62 µg /mL
Interval 1.47 to 1.8
|
1.69 µg /mL
Interval 1.5 to 1.9
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 5
|
0.79 µg /mL
Interval 0.69 to 0.89
|
0.77 µg /mL
Interval 0.69 to 0.87
|
0.82 µg /mL
Interval 0.72 to 0.93
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 6A
|
1.63 µg /mL
Interval 1.39 to 1.91
|
1.43 µg /mL
Interval 1.23 to 1.66
|
1.52 µg /mL
Interval 1.3 to 1.79
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 6B
|
0.66 µg /mL
Interval 0.53 to 0.82
|
0.64 µg /mL
Interval 0.52 to 0.78
|
0.69 µg /mL
Interval 0.56 to 0.85
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 7F
|
2.18 µg /mL
Interval 1.91 to 2.49
|
2.30 µg /mL
Interval 2.05 to 2.59
|
2.48 µg /mL
Interval 2.2 to 2.79
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 9V
|
1.12 µg /mL
Interval 0.97 to 1.28
|
1.11 µg /mL
Interval 0.99 to 1.25
|
1.16 µg /mL
Interval 1.02 to 1.32
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 14
|
7.47 µg /mL
Interval 6.33 to 8.81
|
7.80 µg /mL
Interval 6.79 to 8.96
|
8.03 µg /mL
Interval 6.81 to 9.48
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 18C
|
1.56 µg /mL
Interval 1.33 to 1.84
|
1.55 µg /mL
Interval 1.39 to 1.74
|
1.56 µg /mL
Interval 1.33 to 1.82
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 19A
|
2.70 µg /mL
Interval 2.35 to 3.09
|
2.75 µg /mL
Interval 2.4 to 3.15
|
2.68 µg /mL
Interval 2.38 to 3.03
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 19F
|
2.55 µg /mL
Interval 2.16 to 3.0
|
2.53 µg /mL
Interval 2.19 to 2.92
|
2.79 µg /mL
Interval 2.44 to 3.18
|
|
Concentrations for Anti-PNE Antibodies.
Anti- PNE 23F
|
0.89 µg /mL
Interval 0.73 to 1.09
|
0.83 µg /mL
Interval 0.69 to 1.01
|
0.91 µg /mL
Interval 0.75 to 1.1
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.
Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
GSK217744 Group 1
n=199 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=210 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=210 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response to PT and PRN.
Anti- PT
|
195 Participants
|
204 Participants
|
207 Participants
|
|
Number of Subjects With a Vaccine Response to PT and PRN.
Anti- PRN
|
181 Participants
|
194 Participants
|
198 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK217744 Group 1
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=238 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any pain
|
190 Participants
|
183 Participants
|
155 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any redness
|
151 Participants
|
140 Participants
|
128 Participants
|
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Any swelling
|
124 Participants
|
122 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.
Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK217744 Group 1
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=238 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any drowsiness
|
188 Participants
|
185 Participants
|
171 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any irritability
|
197 Participants
|
205 Participants
|
191 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any loss of appetite
|
135 Participants
|
127 Participants
|
112 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms.
Any fever
|
180 Participants
|
173 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Outcome measures
| Measure |
GSK217744 Group 1
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=242 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=239 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
|
153 Participants
|
165 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Month 0 to Month 3)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Outcome measures
| Measure |
GSK217744 Group 1
n=240 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=242 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=239 Participants
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
|
9 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
GSK217744 Group 1
Serious events: 9 serious events
Other events: 240 other events
Deaths: 0 deaths
GSK217744 Group 2
Serious events: 5 serious events
Other events: 239 other events
Deaths: 0 deaths
Infanrix Hexa Group
Serious events: 4 serious events
Other events: 235 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK217744 Group 1
n=240 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=242 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=239 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
1.7%
4/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
1.3%
3/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Pneumonia
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.41%
1/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.42%
1/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Amoebiasis
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.41%
1/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.41%
1/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.41%
1/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Congenital, familial and genetic disorders
Scaphocephaly
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Skin infection
|
0.42%
1/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.41%
1/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
0.00%
0/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
Other adverse events
| Measure |
GSK217744 Group 1
n=240 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
GSK217744 Group 2
n=242 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
|
Infanrix Hexa Group
n=239 participants at risk
Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
22.1%
53/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
26.4%
64/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
21.3%
51/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Injection site induration
|
9.2%
22/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
5.8%
14/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
10.5%
25/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
14/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
8.7%
21/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
6.3%
15/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
13/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
5.4%
13/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
8.8%
21/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Infections and infestations
Rhinitis
|
7.5%
18/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
5.8%
14/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
3.3%
8/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Eye disorders
Conjunctivitis
|
3.3%
8/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
2.9%
7/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
5.9%
14/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
7/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
5.8%
14/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
3.3%
8/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Pain
|
79.2%
190/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
76.2%
183/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
65.1%
155/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Redness
|
62.9%
151/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
58.3%
140/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
53.8%
128/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Swelling
|
51.7%
124/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
50.8%
122/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
48.3%
115/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Drowsiness
|
78.3%
188/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
77.1%
185/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
71.8%
171/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Irritability
|
82.1%
197/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
85.4%
205/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
80.3%
191/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Loss of appetite
|
56.2%
135/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
52.9%
127/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
47.1%
112/238 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
|
General disorders
Fever
|
75.0%
180/240 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
71.5%
173/242 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
58.6%
140/239 • Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
|
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