Trial Outcomes & Findings for Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants (NCT NCT01090453)

NCT ID: NCT01090453

Last Updated: 2018-08-20

Results Overview

The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 480 participants
• Primary outcome timeframe: At Month 3
• Results posted on: 2018-08-20

Participant Flow

A total of 480 subjects were enrolled in the study.

Participant milestones

Measure	GSK2202083A Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Overall Study STARTED	238	242
Overall Study COMPLETED	225	228
Overall Study NOT COMPLETED	13	14

Reasons for withdrawal

Measure	GSK2202083A Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	7	7
Overall Study Non serious AEs	1	0
Overall Study Protocol Violation	2	0
Overall Study Other	2	4
Overall Study Eligibility Criteria	0	1

Baseline Characteristics

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Baseline characteristics by cohort

Measure	GSK2202083A Group n=238 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=242 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Total n=480 Participants Total of all reporting groups
Age, Continuous	9.10 Weeks STANDARD_DEVIATION 1.15 • n=5 Participants	9.20 Weeks STANDARD_DEVIATION 1.17 • n=7 Participants	9.15 Weeks STANDARD_DEVIATION 1.16 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	111 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Race/Ethnicity, Customized African heritage/African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian-East Asian heritage	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African heritage	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	210 Participants n=5 Participants	216 Participants n=7 Participants	426 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 3

Population: 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 at the post-vaccination time points.

The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Measure	GSK2202083A Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off	204 Participants	188 Participants

PRIMARY outcome

Timeframe: At Month 3

Population: 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 at the post-vaccination time points.

The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.

Outcome measures

Measure	GSK2202083A Group n=214 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=220 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off	210 Participants	219 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.

Outcome measures

Measure	GSK2202083A Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs Anti-PRP ≥ 1.0, Month 3	134 Participants	82 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs Anti-PRP ≥ 0.15, Month 10	145 Participants	123 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs Anti-PRP ≥ 0.15, Month 11	200 Participants	196 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs Anti-PRP ≥ 1.0, Month 10	32 Participants	26 Participants
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs Anti-PRP ≥ 1.0 , Month 11	198 Participants	185 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.

Outcome measures

Measure	GSK2202083A Group n=214 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=220 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs rSBA-MenC ≥ 1:128, Month 3	201 Participants	219 Participants
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs rSBA-MenC ≥ 1:8, Month 10	178 Participants	154 Participants
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs rSBA-MenC ≥ 1:8, Month 11	198 Participants	196 Participants
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs rSBA-MenC ≥ 1:128, Month 10	119 Participants	92 Participants
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs rSBA-MenC ≥ 1:128, Month 11	192 Participants	196 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.

Outcome measures

Measure	GSK2202083A Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Concentrations for Anti-PRP. Anti-PRP at Month 3	1.594 µg/mL Interval 1.306 to 1.946	0.671 µg/mL Interval 0.548 to 0.822
Concentrations for Anti-PRP. Anti-PRP at Month 10	0.340 µg/mL Interval 0.283 to 0.407	0.260 µg/mL Interval 0.217 to 0.311
Concentrations for Anti-PRP. Anti-PRP at Month 11	17.678 µg/mL Interval 15.058 to 20.753	13.737 µg/mL Interval 11.205 to 16.84

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.

Outcome measures

Measure	GSK2202083A Group n=214 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=220 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Titers for rSBA-MenC. rSBA-MenC at Month 3	1119.5 titers Interval 926.4 to 1353.0	3200.5 titers Interval 2737.7 to 3741.6
Titers for rSBA-MenC. rSBA-MenC at Month 10	131.1 titers Interval 105.4 to 163.1	73.7 titers Interval 56.9 to 95.3
Titers for rSBA-MenC. rSBA-MenC at Month 11	2653.8 titers Interval 2225.5 to 3164.6	6028.4 titers Interval 5183.4 to 7011.1

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	GSK2202083A Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-D at Month 3	215 Participants	222 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-D at Month 10	143 Participants	169 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-D at Month 11	200 Participants	196 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-T at Month 3	216 Participants	223 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-T at Month 10	189 Participants	176 Participants
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. Anti-T at Month 11]	200 Participants	196 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.

Outcome measures

Measure	GSK2202083A Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Concentrations for Anti-T and Anti-D. Anti-D at Month 3	0.936 IU/mL Interval 0.825 to 1.062	1.197 IU/mL Interval 1.069 to 1.34
Concentrations for Anti-T and Anti-D. Anti-D at Month 10	0.183 IU/mL Interval 0.159 to 0.211	0.241 IU/mL Interval 0.211 to 0.276
Concentrations for Anti-T and Anti-D. Anti-D at Month 11	4.538 IU/mL Interval 4.127 to 4.99	5.307 IU/mL Interval 4.862 to 5.793
Concentrations for Anti-T and Anti-D. Anti-T at Month 3	2.543 IU/mL Interval 2.332 to 2.774	1.380 IU/mL Interval 1.245 to 1.529
Concentrations for Anti-T and Anti-D. Anti-T at Month 10	0.458 IU/mL Interval 0.407 to 0.515	0.249 IU/mL Interval 0.219 to 0.282
Concentrations for Anti-T and Anti-D. Anti-T at Month 11	7.647 IU/mL Interval 7.063 to 8.279	4.720 IU/mL Interval 4.281 to 5.203

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

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	GSK2202083A Group n=207 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
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 at Month 3	204 Participants	215 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 at Month 10	182 Participants	190 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 at Month 11	194 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 ≥ 100 mIU/mL at Month 3	190 Participants	207 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 at Month 10	118 Participants	146 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 at Month 11	187 Participants	194 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

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	GSK2202083A Group n=207 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=216 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Concentrations for Anti-HBs. Anti-HBs at Month 3	701.6 mIU/mL Interval 578.4 to 851.1	897.8 mIU/mL Interval 764.9 to 1053.9
Concentrations for Anti-HBs. Anti-HBs at Month 10	134.9 mIU/mL Interval 107.6 to 169.2	212.8 mIU/mL Interval 176.7 to 256.2
Concentrations for Anti-HBs. Anti-HBs at Month 11	3934.7 mIU/mL Interval 3121.8 to 4959.3	4850.7 mIU/mL Interval 4059.0 to 5796.9

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.

Outcome measures

Measure	GSK2202083A Group n=196 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=208 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 1 at Month 3	168 Participants	183 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 1 at Month 10	82 Participants	98 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 1 at Month 11	182 Participants	186 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 2 at Month 3	159 Participants	160 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 2 at Month 10	87 Participants	96 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 2 at Month 11	188 Participants	186 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 3 at Month 3	169 Participants	188 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 3 at Month 10	96 Participants	108 Participants
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. Anti-polio 3 at Month 11	188 Participants	185 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.

Outcome measures

Measure	GSK2202083A Group n=196 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=208 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Titers for Anti-polio 1, 2 and 3. Anti-polio 2 at Month 10	10.0 titers Interval 8.4 to 11.9	10.5 titers Interval 8.8 to 12.4
Titers for Anti-polio 1, 2 and 3. Anti-polio 2 at Month 11	379.0 titers Interval 311.0 to 461.9	429.2 titers Interval 357.6 to 515.2
Titers for Anti-polio 1, 2 and 3. Anti-polio 3 at Month 3	70.0 titers Interval 54.0 to 90.7	91.9 titers Interval 71.8 to 117.6
Titers for Anti-polio 1, 2 and 3. Anti-polio 3 at Month 10	13.0 titers Interval 10.7 to 15.9	15.1 titers Interval 12.4 to 18.4
Titers for Anti-polio 1, 2 and 3. Anti-polio 3 at Month 11	506.5 titers Interval 407.9 to 628.9	541.9 titers Interval 443.6 to 661.9
Titers for Anti-polio 1, 2 and 3. Anti-polio 1 at Month 3	37.5 titers Interval 30.1 to 46.8	52.1 titers Interval 42.1 to 64.5
Titers for Anti-polio 1, 2 and 3. Anti-polio 1 at Month 10	9.3 titers Interval 7.8 to 10.9	11.2 titers Interval 9.4 to 13.4
Titers for Anti-polio 1, 2 and 3. Anti-polio 1 at Month 11	268.4 titers Interval 216.5 to 332.7	313.7 titers Interval 258.7 to 380.4
Titers for Anti-polio 1, 2 and 3. Anti-polio 2 at Month 3	28.1 titers Interval 22.6 to 35.0	30.6 titers Interval 24.5 to 38.2

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

Outcome measures

Measure	GSK2202083A Group n=217 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PT at Month 3	217 Participants	223 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PT at Month 10	136 Participants	153 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PT at Month 11	199 Participants	195 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-FHA at Month 3	216 Participants	222 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-FHA at Month 10	196 Participants	195 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-FHA at Month 11	199 Participants	196 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PRN at Month 3	216 Participants	222 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PRN at Month 10	129 Participants	142 Participants
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. Anti-PRN at Month 11	200 Participants	198 Participants

SECONDARY outcome

Timeframe: At Month 3, Month 10 and Month 11.

Population: 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 at the post-vaccination time points.

Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.

Outcome measures

Measure	GSK2202083A Group n=217 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT at Month 3	47.4 EL.U/mL Interval 43.3 to 51.9	49.3 EL.U/mL Interval 45.6 to 53.3
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT at Month 10	8.0 EL.U/mL Interval 7.0 to 9.1	8.3 EL.U/mL Interval 7.4 to 9.3
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT at Month 11	74.9 EL.U/mL Interval 67.2 to 83.5	86.1 EL.U/mL Interval 77.8 to 95.4
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA at Month 3	165.8 EL.U/mL Interval 151.5 to 181.5	172.3 EL.U/mL Interval 157.9 to 188.1
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA at Month 10	37.8 EL.U/mL Interval 33.3 to 43.0	39.7 EL.U/mL Interval 35.3 to 44.6
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA at Month 11	429.6 EL.U/mL Interval 388.4 to 475.0	451.2 EL.U/mL Interval 413.7 to 492.1
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN at Month 3	66.2 EL.U/mL Interval 56.9 to 77.0	74.5 EL.U/mL Interval 64.7 to 85.7
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN at Month 10	9.1 EL.U/mL Interval 7.7 to 10.8	11.0 EL.U/mL Interval 9.3 to 13.1
Concentrations for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN at Month 11	218.0 EL.U/mL Interval 188.5 to 252.2	242.9 EL.U/mL Interval 216.1 to 273.1

SECONDARY outcome

Timeframe: At Month 11.

Population: 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 at the post-vaccination time points.

Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration

Outcome measures

Measure	GSK2202083A Group n=193 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=193 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA	183 Participants	185 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN	191 Participants	190 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-PT	185 Participants	186 Participants

SECONDARY outcome

Timeframe: At Month 3 and Month 11

Population: 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 at the post-vaccination time points.

The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 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	GSK2202083A Group n=87 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=94 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 14 at Month 11 ≥ 0.2	86 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 1 at Month 3 ≥ 0.2	86 Participants	94 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 1 at Month 11 ≥ 0.2	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 3 at Month 3 ≥ 0.2	82 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 23F at Month 3 ≥ 0.2	52 Participants	76 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 3 at Month 11 ≥ 0.2	83 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 4 at Month 3 ≥ 0.2	78 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 4 at Month 11 ≥ 0.2	85 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 5 at Month 3 ≥ 0.2	75 Participants	89 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 5 at Month 11 ≥ 0.2	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6A at Month 3 ≥ 0.2	70 Participants	86 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6A at Month 11 ≥ 0.2	84 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6B at Month 3 ≥ 0.2	20 Participants	27 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6B at Month 11 ≥ 0.2	83 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 7F at Month 3 ≥ 0.2	83 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 7F at Month 11 ≥ 0.2	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 9V at Month 3 ≥ 0.2	77 Participants	89 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 9V at Month 11 ≥ 0.2	85 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 14 at Month 3 ≥ 0.2	85 Participants	92 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 18C at Month 3 ≥ 0.2	79 Participants	89 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 18C at Month 11 ≥ 0.2	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19A at Month 3 ≥ 0.2	74 Participants	91 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19A at Month 11 ≥ 0.2	85 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19F at Month 3 ≥ 0.2	79 Participants	92 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19F at Month 11 ≥ 0.2	84 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 23F at Month 11 ≥ 0.2	84 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 1 at Month 3 ≥ 0.05	87 Participants	94 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 1 at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 3 at Month 3 ≥ 0.05	83 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 3 at Month 11 ≥ 0.05	85 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 4 at Month 3 ≥ 0.05	82 Participants	94 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 4 at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 5 at Month 3 ≥ 0.05	79 Participants	91 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 5 at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6A at Month 3 ≥ 0.05	79 Participants	91 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6A at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6B at Month 3 ≥ 0.05	54 Participants	72 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 6B at Month 11 ≥ 0.05	85 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 7F at Month 3 ≥ 0.05	84 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 7F at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 9V at Month 3 ≥ 0.05	80 Participants	91 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 9V at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 14 at Month 3 ≥ 0.05	85 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 14 at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 18C at Month 3 ≥ 0.05	83 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 23F at Month 11 ≥ 0.05	85 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 18C at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19A at Month 3 ≥ 0.05	83 Participants	93 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19A at Month 11 ≥ 0.05	86 Participants	83 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19F at Month 3 ≥ 0.05	81 Participants	92 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 19F at Month 11 ≥ 0.05	85 Participants	82 Participants
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. Anti-PNE 23F at Month 3 ≥ 0.05	73 Participants	89 Participants

SECONDARY outcome

Timeframe: At Month 3 and Month 11

Population: 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 at the post-vaccination time points.

Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.

Outcome measures

Measure	GSK2202083A Group n=87 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=94 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Concentrations for Anti-PNE Serotypes. Anti-PNE 1 at Month 3 ≥ 0.2	1.66 µg/mL Interval 1.37 to 2.0	1.89 µg/mL Interval 1.59 to 2.25
Concentrations for Anti-PNE Serotypes. Anti-PNE 1 at Month 11 ≥ 0.2	4.99 µg/mL Interval 4.13 to 6.02	4.79 µg/mL Interval 4.12 to 5.56
Concentrations for Anti-PNE Serotypes. Anti-PNE 3 at Month 3 ≥ 0.2	1.16 µg/mL Interval 0.99 to 1.35	1.15 µg/mL Interval 1.02 to 1.3
Concentrations for Anti-PNE Serotypes. Anti-PNE 3 at Month 11 ≥ 0.2	1.74 µg/mL Interval 1.41 to 2.16	1.82 µg/mL Interval 1.54 to 2.15
Concentrations for Anti-PNE Serotypes. Anti-PNE 4 at Month 3 ≥ 0.2	1.40 µg/mL Interval 1.14 to 1.73	1.55 µg/mL Interval 1.32 to 1.82
Concentrations for Anti-PNE Serotypes. Anti-PNE 4 at Month 11 ≥ 0.2	4.19 µg/mL Interval 3.46 to 5.06	4.43 µg/mL Interval 3.77 to 5.21
Concentrations for Anti-PNE Serotypes. Anti-PNE 5 at Month 3 ≥ 0.2	1.83 µg/mL Interval 1.38 to 2.43	2.17 µg/mL Interval 1.76 to 2.68
Concentrations for Anti-PNE Serotypes. Anti-PNE 5 at Month 11 ≥ 0.2	6.68 µg/mL Interval 5.47 to 8.17	6.75 µg/mL Interval 5.67 to 8.02
Concentrations for Anti-PNE Serotypes. Anti-PNE 6A at Month 3 ≥ 0.2	1.06 µg/mL Interval 0.82 to 1.39	1.20 µg/mL Interval 0.98 to 1.48
Concentrations for Anti-PNE Serotypes. Anti-PNE 6A at Month 11 ≥ 0.2	7.34 µg/mL Interval 5.87 to 9.16	7.96 µg/mL Interval 6.95 to 9.11
Concentrations for Anti-PNE Serotypes. Anti-PNE 6B at Month 3 ≥ 0.2	0.09 µg/mL Interval 0.07 to 0.12	0.12 µg/mL Interval 0.09 to 0.15
Concentrations for Anti-PNE Serotypes. Anti-PNE 6B at Month 11 ≥ 0.2	2.23 µg/mL Interval 1.68 to 2.97	2.78 µg/mL Interval 2.23 to 3.46
Concentrations for Anti-PNE Serotypes. Anti-PNE 7F at Month 3 ≥ 0.2	2.72 µg/mL Interval 2.3 to 3.21	2.75 µg/mL Interval 2.44 to 3.1
Concentrations for Anti-PNE Serotypes. Anti-PNE 7F at Month 11 ≥ 0.2	6.67 µg/mL Interval 5.82 to 7.65	6.47 µg/mL Interval 5.68 to 7.38
Concentrations for Anti-PNE Serotypes. Anti-PNE 9V at Month 3 ≥ 0.2	1.36 µg/mL Interval 1.02 to 1.82	1.42 µg/mL Interval 1.17 to 1.74
Concentrations for Anti-PNE Serotypes. Anti-PNE 9V at Month 11 ≥ 0.2	6.12 µg/mL Interval 4.99 to 7.5	6.80 µg/mL Interval 5.78 to 8.0
Concentrations for Anti-PNE Serotypes. Anti-PNE 14 at Month 3 ≥ 0.2	3.03 µg/mL Interval 2.42 to 3.8	2.96 µg/mL Interval 2.33 to 3.76
Concentrations for Anti-PNE Serotypes. Anti-PNE 14 at Month 11 ≥ 0.2	10.41 µg/mL Interval 8.56 to 12.65	7.50 µg/mL Interval 6.03 to 9.34
Concentrations for Anti-PNE Serotypes. Anti-PNE 18C at Month 3 ≥ 0.2	1.81 µg/mL Interval 1.4 to 2.34	2.08 µg/mL Interval 1.72 to 2.51
Concentrations for Anti-PNE Serotypes. Anti-PNE 18C at Month 11 ≥ 0.2	6.20 µg/mL Interval 5.06 to 7.59	5.91 µg/mL Interval 4.97 to 7.02
Concentrations for Anti-PNE Serotypes. Anti-PNE 19A at Month 3 ≥ 0.2	1.05 µg/mL Interval 0.81 to 1.36	1.30 µg/mL Interval 1.1 to 1.54
Concentrations for Anti-PNE Serotypes. Anti-PNE 19A at Month 11 ≥ 0.2	5.73 µg/mL Interval 4.55 to 7.2	5.22 µg/mL Interval 4.26 to 6.41
Concentrations for Anti-PNE Serotypes. Anti-PNE 19F at Month 3 ≥ 0.2	2.82 µg/mL Interval 2.25 to 3.53	3.36 µg/mL Interval 2.83 to 3.98
Concentrations for Anti-PNE Serotypes. Anti-PNE 19F at Month 11 ≥ 0.2	5.47 µg/mL Interval 4.36 to 6.86	5.70 µg/mL Interval 4.81 to 6.75
Concentrations for Anti-PNE Serotypes. Anti-PNE 23F at Month 3 ≥ 0.2	0.40 µg/mL Interval 0.29 to 0.54	0.54 µg/mL Interval 0.43 to 0.68
Concentrations for Anti-PNE Serotypes. Anti-PNE 23F at Month 11 ≥ 0.2	4.38 µg/mL Interval 3.33 to 5.77	4.51 µg/mL Interval 3.57 to 5.69

SECONDARY outcome

Timeframe: At Month 11.

Population: 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 at the post-vaccination time points.

The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.

Outcome measures

Measure	GSK2202083A Group n=197 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=193 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. Anti-PRP ≥2	195 Participants	189 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. Anti-PRP ≥4	191 Participants	186 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. Anti-PRP ≥6	189 Participants	176 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. Anti-PRP ≥8	179 Participants	170 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. Anti-PRP ≥10	173 Participants	166 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. rSBA-MenC ≥2	189 Participants	185 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. rSBA-MenC ≥4	177 Participants	185 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. rSBA-MenC ≥6	160 Participants	182 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. rSBA-MenC ≥8	148 Participants	180 Participants
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. rSBA-MenC ≥10	135 Participants	178 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

Outcome measures

Measure	GSK2202083A Group n=238 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=241 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects Reporting Any Solicited Local Symptoms. Any pain	155 Participants	181 Participants
Number of Subjects Reporting Any Solicited Local Symptoms. Any redness	171 Participants	183 Participants
Number of Subjects Reporting Any Solicited Local Symptoms. Any swelling	147 Participants	163 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.

Solicited local symptoms assessed were drowsiness, irritability/fussiness, 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	GSK2202083A Group n=238 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=241 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects Reporting Any Solicited General Symptoms. Any drowsiness	188 Participants	190 Participants
Number of Subjects Reporting Any Solicited General Symptoms. Any irritability	208 Participants	207 Participants
Number of Subjects Reporting Any Solicited General Symptoms. Any loss of appetite	169 Participants	154 Participants
Number of Subjects Reporting Any Solicited General Symptoms. Any fever	165 Participants	167 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 with at least one vaccine administration documented.

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	GSK2202083A Group n=238 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=242 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	148 Subjects	158 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Month 0 to Month 11)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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	GSK2202083A Group n=238 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	Infanrix Hexa Group n=242 Participants Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).	12 Participants	15 Participants

Adverse Events

Infanrix Hexa Group

Serious events: 15 serious events

Other events: 237 other events

Deaths: 0 deaths

GSK2202083A Group

Serious events: 12 serious events

Other events: 232 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infanrix Hexa Group n=242 participants at risk Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	GSK2202083A Group n=238 participants at risk Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Injury, poisoning and procedural complications Concussion	1.2% 3/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Gastroenteritis	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Accidental drug intake by child	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Apnoea	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Aspiration	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Bronchopneumonia	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Choking	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Cow's milk intolerance	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Croup infectious	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Crying	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Gastroenteritis adenovirus	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Gastroenteritis norovirus	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Head injury	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Limb injury	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Otitis media	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Pharyngitis	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Pneumonia	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Pyelonephritis	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Rash	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Sandifer's syndrome	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Tendon rupture	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Nervous system disorders Tremor	0.00% 0/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.42% 1/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Upper respiratory tract infection	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Urinary tract infection	0.41% 1/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Other adverse events

Measure	Infanrix Hexa Group n=242 participants at risk Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.	GSK2202083A Group n=238 participants at risk Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Infections and infestations Rhinitis	11.2% 27/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	13.0% 31/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Upper respiratory tract infection	6.2% 15/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.4% 20/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 14/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.0% 19/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Diarrhoea	7.0% 17/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.0% 12/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Nasopharyngitis	6.6% 16/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	4.2% 10/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Vomiting	5.8% 14/242 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	3.8% 9/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Pain	75.1% 181/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	65.1% 155/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Redness	75.9% 183/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	71.8% 171/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Swelling	67.6% 163/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	61.8% 147/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Drowsiness	78.8% 190/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	79.0% 188/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Irritability	85.9% 207/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	87.4% 208/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Loss of appetite	63.9% 154/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	71.0% 169/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Temperature	69.3% 167/241 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	69.3% 165/238 • Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11). For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

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