Trial Outcomes & Findings for Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) (NCT NCT01453998)

Results Overview

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

657 participants

Primary outcome timeframe

1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Results posted on

2020-07-17

Participant Flow

A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa vaccine.

Participant milestones

Participant milestones
Measure	GSK217744 Group 1 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Before Protocol Amendment 2 STARTED	85	88	99
Before Protocol Amendment 2 COMPLETED	85	88	99
Before Protocol Amendment 2 NOT COMPLETED	0	0	0
After Protocol Amendment 2. STARTED	131	130	124
After Protocol Amendment 2. COMPLETED	130	130	124
After Protocol Amendment 2. NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK217744 Group 1 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
After Protocol Amendment 2. Withdrawal by Subject	1	0	0

Baseline Characteristics

Data available for subjects enrolled before protocol amendment 2.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK217744 Group 1 n=216 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=218 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=223 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Total n=657 Participants Total of all reporting groups
Age, Continuous	14.1 Months STANDARD_DEVIATION 0.6 • n=131 Participants • Data available for subjects enrolled after protocol amendment 2.	13.9 Months STANDARD_DEVIATION 0.6 • n=130 Participants • Data available for subjects enrolled after protocol amendment 2.	14.0 Months STANDARD_DEVIATION 0.6 • n=124 Participants • Data available for subjects enrolled after protocol amendment 2.	14.00 Months STANDARD_DEVIATION 0.61 • n=385 Participants • Data available for subjects enrolled after protocol amendment 2.
Sex: Female, Male Female	61 Participants n=131 Participants • Data available for subjects enrolled before protocol amendment 2.	76 Participants n=130 Participants • Data available for subjects enrolled before protocol amendment 2.	53 Participants n=124 Participants • Data available for subjects enrolled before protocol amendment 2.	190 Participants n=385 Participants • Data available for subjects enrolled before protocol amendment 2.
Sex: Female, Male Male	70 Participants n=131 Participants • Data available for subjects enrolled before protocol amendment 2.	54 Participants n=130 Participants • Data available for subjects enrolled before protocol amendment 2.	71 Participants n=124 Participants • Data available for subjects enrolled before protocol amendment 2.	195 Participants n=385 Participants • Data available for subjects enrolled before protocol amendment 2.
Race/Ethnicity, Customized White - Arabic / north African heritage	0 Participants n=131 Participants • Data available for subjects enrolled after protocol amendment 2.	0 Participants n=130 Participants • Data available for subjects enrolled after protocol amendment 2.	3 Participants n=124 Participants • Data available for subjects enrolled after protocol amendment 2.	3 Participants n=385 Participants • Data available for subjects enrolled after protocol amendment 2.
Race/Ethnicity, Customized White - Caucasian / European heritage	79 Participants n=85 Participants • Data available for subjects enrolled before protocol amendment 2.	83 Participants n=88 Participants • Data available for subjects enrolled before protocol amendment 2.	91 Participants n=99 Participants • Data available for subjects enrolled before protocol amendment 2.	253 Participants n=272 Participants • Data available for subjects enrolled before protocol amendment 2.
Race/Ethnicity, Customized Other: Mixed	81 Participants n=131 Participants • Data available for subjects enrolled after protocol amendment 2.	84 Participants n=130 Participants • Data available for subjects enrolled after protocol amendment 2.	81 Participants n=124 Participants • Data available for subjects enrolled after protocol amendment 2.	246 Participants n=385 Participants • Data available for subjects enrolled after protocol amendment 2.
Race/Ethnicity, Customized African heritage / African American	1 Participants n=131 Participants • Data available for subjects enrolled after protocol amendment 2.	0 Participants n=130 Participants • Data available for subjects enrolled after protocol amendment 2.	1 Participants n=124 Participants • Data available for subjects enrolled after protocol amendment 2.	2 Participants n=385 Participants • Data available for subjects enrolled after protocol amendment 2.
Race/Ethnicity, Customized White - caucasian / European heritage	49 Participants n=131 Participants • Data available for subjects enrolled after protocol amendment 2.	46 Participants n=130 Participants • Data available for subjects enrolled after protocol amendment 2.	39 Participants n=124 Participants • Data available for subjects enrolled after protocol amendment 2.	134 Participants n=385 Participants • Data available for subjects enrolled after protocol amendment 2.

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D, POST	81 Participants	82 Participants	90 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T, POST	81 Participants	82 Participants	90 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=118 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies Anti-D, POST	123 Participants	122 Participants	118 Participants
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies Anti-T, POST	123 Participants	122 Participants	118 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=84 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens	78 Participants	78 Participants	84 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects Against Anti-HBs Antigens	121 Participants	113 Participants	114 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=77 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=72 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 1, POST	76 Participants	72 Participants	85 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 2, POST	62 Participants	60 Participants	76 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 3, POST	64 Participants	63 Participants	71 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=113 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=107 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=103 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 1, POST	111 Participants	107 Participants	102 Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 2, POST	96 Participants	96 Participants	87 Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 3, POST	113 Participants	103 Participants	98 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)	81 Participants	82 Participants	90 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=118 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-PRP	122 Participants	122 Participants	117 Participants

PRIMARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PT, POST	76.1 EL.U/mL Interval 66.1 to 87.6	74.3 EL.U/mL Interval 62.6 to 88.1	96.0 EL.U/mL Interval 83.5 to 110.3
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-FHA, POST	393.7 EL.U/mL Interval 346.4 to 447.6	372.4 EL.U/mL Interval 332.7 to 416.7	423.0 EL.U/mL Interval 368.1 to 485.9
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PRN, POST	213.0 EL.U/mL Interval 178.1 to 254.7	180.0 EL.U/mL Interval 154.2 to 210.1	372.9 EL.U/mL Interval 309.3 to 449.5

PRIMARY outcome

Timeframe: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-PT, POST	92.4 EL.U/mL Interval 80.6 to 106.0	93.6 EL.U/mL Interval 83.1 to 105.5	132.6 EL.U/mL Interval 114.9 to 153.0
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, POST	467.3 EL.U/mL Interval 417.3 to 523.3	446.2 EL.U/mL Interval 402.3 to 494.9	582.9 EL.U/mL Interval 517.1 to 657.1
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, POST	253.2 EL.U/mL Interval 216.9 to 295.6	181.0 EL.U/mL Interval 154.8 to 211.7	401.1 EL.U/mL Interval 342.2 to 470.0

SECONDARY outcome

Timeframe: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D, POST	5.652 IU/mL Interval 4.985 to 6.408	5.494 IU/mL Interval 4.891 to 6.171	6.772 IU/mL Interval 5.897 to 7.777
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T, POST	5.015 IU/mL Interval 4.341 to 5.794	5.034 IU/mL Interval 4.366 to 5.803	5.571 IU/mL Interval 4.869 to 6.374
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D, PRE	0.357 IU/mL Interval 0.305 to 0.419	0.445 IU/mL Interval 0.381 to 0.52	0.401 IU/mL Interval 0.343 to 0.468
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T, PRE	0.358 IU/mL Interval 0.301 to 0.427	0.362 IU/mL Interval 0.306 to 0.428	0.394 IU/mL Interval 0.337 to 0.459

SECONDARY outcome

Timeframe: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=118 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-D and Anti-T Antibodies Anti-D, POST	6.327 IU/mL Interval 5.698 to 7.025	5.452 IU/mL Interval 4.956 to 5.998	7.192 IU/mL Interval 6.419 to 8.059
Concentrations for Anti-D and Anti-T Antibodies Anti-T, POST	5.986 IU/mL Interval 5.204 to 6.885	5.316 IU/mL Interval 4.716 to 5.992	5.993 IU/mL Interval 5.222 to 6.878
Concentrations for Anti-D and Anti-T Antibodies Anti-D, PRE	0.247 IU/mL Interval 0.213 to 0.287	0.278 IU/mL Interval 0.244 to 0.317	0.304 IU/mL Interval 0.258 to 0.36
Concentrations for Anti-D and Anti-T Antibodies Anti-T, PRE	0.364 IU/mL Interval 0.313 to 0.422	0.332 IU/mL Interval 0.289 to 0.38	0.331 IU/mL Interval 0.285 to 0.383

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D, PRE	78 Participants	80 Participants	84 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T, PRE	76 Participants	78 Participants	85 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies Anti-D, PRE	107 Participants	114 Participants	104 Participants
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies Anti-T, PRE	116 Participants	114 Participants	111 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=89 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PT, PRE	10.5 EL.U/mL. Interval 8.8 to 12.6	9.5 EL.U/mL. Interval 7.9 to 11.4	12.7 EL.U/mL. Interval 10.8 to 15.0
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-FHA, PRE	41.7 EL.U/mL. Interval 35.4 to 49.2	36.9 EL.U/mL. Interval 31.5 to 43.3	47.1 EL.U/mL. Interval 40.3 to 55.1
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PRN, PRE	12.8 EL.U/mL. Interval 10.4 to 15.7	10.8 EL.U/mL. Interval 8.9 to 13.1	18.2 EL.U/mL. Interval 15.0 to 22.1

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-PT, PRE	8.3 EL.U/mL Interval 7.2 to 9.7	7.9 EL.U/mL Interval 6.8 to 9.1	9.9 EL.U/mL Interval 8.5 to 11.5
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, PRE	37.6 EL.U/mL Interval 32.5 to 43.4	34.0 EL.U/mL Interval 28.7 to 40.4	45.7 EL.U/mL Interval 38.8 to 53.9
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, PRE	11.6 EL.U/mL Interval 9.7 to 13.9	9.7 EL.U/mL Interval 8.1 to 11.7	15.6 EL.U/mL Interval 13.0 to 18.7

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PT, POST	79 Participants	81 Participants	89 Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-FHA, POST	81 Participants	82 Participants	90 Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PRN, POST	81 Participants	81 Participants	89 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-PT, POST	118 Participants	121 Participants	116 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-FHA, POST	123 Participants	122 Participants	117 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-PRN, POST	122 Participants	122 Participants	117 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=84 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations	2233.3 mIU/mL Interval 1479.7 to 3370.8	2026.3 mIU/mL Interval 1389.4 to 2955.2	2685.7 mIU/mL Interval 1868.8 to 3859.7

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Anti-HBs Antibody Concentrations	2229.3 mIU/mL Interval 1625.5 to 3057.5	1729.8 mIU/mL Interval 1240.6 to 2411.9	3711.4 mIU/mL Interval 2729.7 to 5046.1

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=74 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=84 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Anti-Hepatitis B (Anti-HBs) Antibody Concentration	130.3 mIU/mL Interval 91.2 to 186.0	124.4 mIU/mL Interval 89.5 to 173.0	166.4 mIU/mL Interval 112.8 to 245.5

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=120 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=119 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Anti-HBs Antibody Concentrations	94.9 mIU/mL Interval 72.2 to 124.8	61.8 mIU/mL Interval 45.7 to 83.5	125.9 mIU/mL Interval 94.6 to 167.7

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=74 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=79 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=84 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens	68 Participants	74 Participants	78 Participants

SECONDARY outcome

Timeframe: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=120 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=119 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=115 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects Against Anti-HBs Antigens	108 Participants	100 Participants	106 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=73 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=74 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=80 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-poliovirus Types 1, 2, 3 Anti-Polio 1, PRE	18.2 Titers Interval 13.7 to 24.1	17.8 Titers Interval 13.5 to 23.5	22.4 Titers Interval 16.8 to 29.9
Concentrations for Anti-poliovirus Types 1, 2, 3 Anti-Polio 2, PRE	12.7 Titers Interval 9.5 to 16.9	17.1 Titers Interval 12.3 to 23.8	16.6 Titers Interval 12.0 to 22.8
Concentrations for Anti-poliovirus Types 1, 2, 3 Anti-Polio, 3 PRE	24.7 Titers Interval 17.1 to 35.8	16.8 Titers Interval 12.0 to 23.5	26.6 Titers Interval 19.2 to 36.9

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=77 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=72 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentration for Anti-poliovirus Types 1, 2, 3 Anti-Polio 1, POST	572.9 Titers Interval 435.5 to 753.6	558.3 Titers Interval 422.0 to 738.8	902.1 Titers Interval 698.4 to 1165.0
Concentration for Anti-poliovirus Types 1, 2, 3 Anti-Polio 2, POST	629.7 Titers Interval 452.6 to 876.1	668.7 Titers Interval 489.9 to 912.7	1184.9 Titers Interval 901.1 to 1558.1
Concentration for Anti-poliovirus Types 1, 2, 3 Anti-Polio 3, POST	1147.5 Titers Interval 846.2 to 1556.0	614.0 Titers Interval 453.9 to 830.6	1120.7 Titers Interval 793.0 to 1583.9

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=113 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=107 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=103 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 1, POST	1121.0 Titers Interval 904.2 to 1389.8	1099.6 Titers Interval 905.2 to 1335.8	1386.2 Titers Interval 1091.8 to 1760.0
Concentrations for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 2, POST	1485.3 Titers Interval 1182.4 to 1865.8	1215.6 Titers Interval 973.8 to 1517.4	1537.2 Titers Interval 1191.0 to 1984.1
Concentrations for Anti-poliovirus Types 1, 2 and 3 Anti-Polio 3, POST	1851.2 Titers Interval 1473.2 to 2326.1	1960.4 Titers Interval 1574.0 to 2441.5	2376.4 Titers Interval 1874.2 to 3013.2

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=108 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=109 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=104 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentration for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 1, PRE	53.5 Titers Interval 39.6 to 72.4	50.7 Titers Interval 37.2 to 69.2	70.8 Titers Interval 52.4 to 95.8
Concentration for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 2, PRE	76.6 Titers Interval 50.3 to 116.7	55.0 Titers Interval 38.2 to 79.3	82.7 Titers Interval 55.6 to 122.9
Concentration for Anti-poliovirus Type 1, 2 and 3 Anti-Polio, 3 PRE	67.8 Titers Interval 47.3 to 97.2	73.8 Titers Interval 52.2 to 104.2	93.9 Titers Interval 64.4 to 136.8

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=73 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=74 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=80 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 1, PRE	50 Participants	54 Participants	56 Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio 2, PRE	38 Participants	44 Participants	44 Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 Anti-Polio, 3 PRE	51 Participants	43 Participants	61 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=108 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=109 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=104 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 Anti-Polio 1, PRE	95 Participants	91 Participants	92 Participants
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 Anti-Polio 2, PRE	78 Participants	81 Participants	74 Participants
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 Anti-Polio, 3 PRE	96 Participants	99 Participants	91 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=90 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies	12.765 µg /mL Interval 9.3 to 17.52	15.904 µg /mL Interval 11.723 to 21.576	17.099 µg /mL Interval 12.966 to 22.55

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=122 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=118 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-PRP Antibodies	21.462 µg /mL Interval 16.65 to 27.664	15.903 µg /mL Interval 12.132 to 20.848	17.429 µg /mL Interval 13.429 to 22.62

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=89 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies	0.173 µg /mL Interval 0.138 to 0.216	0.175 µg /mL Interval 0.142 to 0.216	0.236 µg /mL Interval 0.182 to 0.307

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies	0.328 µg /mL Interval 0.262 to 0.409	0.288 µg /mL Interval 0.227 to 0.365	0.334 µg /mL Interval 0.254 to 0.439

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=89 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PT, PRE	68 Participants	65 Participants	78 Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-FHA, PRE	81 Participants	81 Participants	88 Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) Anti-PRN, PRE	68 Participants	69 Participants	83 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-PT, PRE	95 Participants	94 Participants	97 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-FHA, PRE	122 Participants	117 Participants	116 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN Anti-PRN, PRE	98 Participants	92 Participants	105 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=89 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)	41 Participants	45 Participants	52 Participants

SECONDARY outcome

Timeframe: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=117 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seroprotected Subjects for Anti-PRP	92 Participants	78 Participants	81 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=50 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=50 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=53 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 23F	3.74 µg /mL Interval 2.87 to 4.88	4.54 µg /mL Interval 3.67 to 5.63	3.94 µg /mL Interval 2.97 to 5.23
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 1	2.07 µg /mL Interval 1.69 to 2.53	2.16 µg /mL Interval 1.75 to 2.68	2.27 µg /mL Interval 1.84 to 2.8
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 3	0.76 µg /mL Interval 0.62 to 0.93	0.87 µg /mL Interval 0.66 to 1.15	0.88 µg /mL Interval 0.69 to 1.14
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 4	1.87 µg /mL Interval 1.51 to 2.32	1.83 µg /mL Interval 1.46 to 2.28	2.14 µg /mL Interval 1.72 to 2.66
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 5	1.18 µg /mL Interval 0.97 to 1.42	1.10 µg /mL Interval 0.92 to 1.33	1.21 µg /mL Interval 0.99 to 1.49
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 6A	7.71 µg /mL Interval 6.49 to 9.16	6.92 µg /mL Interval 5.53 to 8.64	8.63 µg /mL Interval 6.79 to 10.96
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 6B	4.24 µg /mL Interval 3.39 to 5.3	4.21 µg /mL Interval 3.17 to 5.59	4.58 µg /mL Interval 3.45 to 6.08
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 7F	3.27 µg /mL Interval 2.75 to 3.89	3.42 µg /mL Interval 2.94 to 3.97	4.27 µg /mL Interval 3.58 to 5.08
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 9V	1.68 µg /mL Interval 1.33 to 2.11	1.52 µg /mL Interval 1.25 to 1.85	1.63 µg /mL Interval 1.29 to 2.06
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 14	8.22 µg /mL Interval 6.27 to 10.77	8.80 µg /mL Interval 7.01 to 11.06	8.97 µg /mL Interval 7.29 to 11.02
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 18C	1.50 µg /mL Interval 1.13 to 1.99	1.63 µg /mL Interval 1.32 to 2.01	1.64 µg /mL Interval 1.33 to 2.02
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 19A	7.00 µg /mL Interval 5.76 to 8.51	8.05 µg /mL Interval 6.39 to 10.13	6.70 µg /mL Interval 5.14 to 8.73
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies Anti- PNE 19F	7.15 µg /mL Interval 5.86 to 8.74	7.34 µg /mL Interval 5.89 to 9.15	6.72 µg /mL Interval 5.32 to 8.48

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=23 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=21 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=20 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Concentrations for Anti-PNE Antibodies Anti- PNE 1	2.54 µg /mL Interval 1.93 to 3.34	2.47 µg /mL Interval 1.83 to 3.35	3.47 µg /mL Interval 2.23 to 5.41
Concentrations for Anti-PNE Antibodies Anti-PNE 14	7.47 µg /mL Interval 5.68 to 9.83	8.12 µg /mL Interval 6.04 to 10.93	9.28 µg /mL Interval 6.15 to 14.01
Concentrations for Anti-PNE Antibodies Anti-PNE 18C	1.80 µg /mL Interval 1.34 to 2.4	1.52 µg /mL Interval 1.09 to 2.11	2.09 µg /mL Interval 1.41 to 3.11
Concentrations for Anti-PNE Antibodies Anti- PNE 3	0.76 µg /mL Interval 0.59 to 0.96	0.82 µg /mL Interval 0.6 to 1.13	0.92 µg /mL Interval 0.66 to 1.3
Concentrations for Anti-PNE Antibodies Anti-PNE 4	2.03 µg /mL Interval 1.53 to 2.68	2.10 µg /mL Interval 1.59 to 2.79	2.57 µg /mL Interval 1.65 to 4.01
Concentrations for Anti-PNE Antibodies Anti-PNE 5	1.26 µg /mL Interval 0.97 to 1.63	1.24 µg /mL Interval 0.98 to 1.57	1.29 µg /mL Interval 0.89 to 1.87
Concentrations for Anti-PNE Antibodies Anti-PNE 6A	10.64 µg /mL Interval 7.94 to 14.25	7.67 µg /mL Interval 6.18 to 9.53	7.47 µg /mL Interval 4.76 to 11.7
Concentrations for Anti-PNE Antibodies Anti-PNE 6B	5.04 µg /mL Interval 3.74 to 6.79	4.56 µg /mL Interval 3.16 to 6.59	6.62 µg /mL Interval 3.9 to 11.24
Concentrations for Anti-PNE Antibodies Anti-PNE 7F	4.20 µg /mL Interval 3.45 to 5.11	3.97 µg /mL Interval 2.98 to 5.29	4.67 µg /mL Interval 3.16 to 6.89
Concentrations for Anti-PNE Antibodies Anti-PNE 19A	8.79 µg /mL Interval 6.53 to 11.82	6.22 µg /mL Interval 4.99 to 7.76	9.10 µg /mL Interval 5.23 to 15.84
Concentrations for Anti-PNE Antibodies Anti-PNE 19F	8.09 µg /mL Interval 5.48 to 11.95	7.11 µg /mL Interval 5.21 to 9.7	5.56 µg /mL Interval 3.38 to 9.14
Concentrations for Anti-PNE Antibodies Anti-PNE 23F	5.31 µg /mL Interval 4.29 to 6.57	4.00 µg /mL Interval 3.05 to 5.24	5.82 µg /mL Interval 3.59 to 9.44
Concentrations for Anti-PNE Antibodies Anti-PNE 9V	2.20 µg /mL Interval 1.66 to 2.93	1.42 µg /mL Interval 1.1 to 1.85	1.85 µg /mL Interval 1.21 to 2.83

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=50 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=50 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=53 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 1	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 3	40 Participants	43 Participants	43 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 4	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 5	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 6A	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 6B	50 Participants	49 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 7F	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 9V	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 14	49 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 18C	49 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 19A	49 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 19F	50 Participants	50 Participants	53 Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes Anti- PNE 23F	50 Participants	47 Participants	52 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=23 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=21 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=20 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Seropositive Subjects for Anti-PNE Serotypes Anti- PNE 1	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti- PNE 3	21 Participants	18 Participants	16 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 4	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 5	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 6A	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 6B	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 7F	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 9V	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 14	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 18C	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 19A	23 Participants	21 Participants	19 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 19F	23 Participants	21 Participants	20 Participants
Number of Seropositive Subjects for Anti-PNE Serotypes Anti-PNE 23F	23 Participants	21 Participants	20 Participants

SECONDARY outcome

Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=81 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=82 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=88 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) Anti-PT	72 Participants	77 Participants	86 Participants
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) Anti-FHA	79 Participants	81 Participants	87 Participants
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) Anti-PRN	81 Participants	80 Participants	87 Participants

SECONDARY outcome

Timeframe: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=123 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=121 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=116 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects With Booster Response to Anti-pertussis Antigens Anti-PT	118 Subjects	119 Subjects	110 Subjects
Number of Subjects With Booster Response to Anti-pertussis Antigens Anti-FHA	120 Subjects	115 Subjects	113 Subjects
Number of Subjects With Booster Response to Anti-pertussis Antigens Anti-PRN	121 Subjects	120 Subjects	115 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

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

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

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=88 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=99 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Solicited Local Symptoms Any pain	56 Participants	67 Participants	63 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any redness	55 Participants	56 Participants	59 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any swelling	45 Participants	43 Participants	48 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

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

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

Outcome measures

Outcome measures
Measure	GSK217744 Group 1 n=131 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=130 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=124 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Solicited Local Symptom Any pain	76 Participants	66 Participants	64 Participants
Number of Subjects Reporting Any Solicited Local Symptom Any redness	47 Participants	36 Participants	40 Participants
Number of Subjects Reporting Any Solicited Local Symptom Any swelling	43 Participants	34 Participants	38 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

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

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

Outcome measures
Measure	GSK217744 Group 1 n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=88 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=99 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Solicited General Symptoms Any drowsiness	54 Participants	47 Participants	47 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any irritability/fussiness	69 Participants	73 Participants	74 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any loss of appetite	43 Participants	45 Participants	46 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any fever	42 Participants	41 Participants	37 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

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

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

Outcome measures
Measure	GSK217744 Group 1 n=131 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=130 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=124 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Solicited General Symptom Any drowsiness	52 Participants	40 Participants	40 Participants
Number of Subjects Reporting Any Solicited General Symptom Any irritability/fussiness	66 Participants	58 Participants	62 Participants
Number of Subjects Reporting Any Solicited General Symptom Any loss of appetite	42 Participants	37 Participants	34 Participants
Number of Subjects Reporting Any Solicited General Symptom Any fever	58 Participants	50 Participants	52 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster 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

Outcome measures
Measure	GSK217744 Group 1 n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=88 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=99 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	42 Participants	39 Participants	67 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster 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

Outcome measures
Measure	GSK217744 Group 1 n=131 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=130 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=124 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Unsolicited AEs	38 Participants	27 Participants	31 Participants

SECONDARY outcome

Timeframe: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster 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

Outcome measures
Measure	GSK217744 Group 1 n=85 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=88 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=99 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster 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

Outcome measures
Measure	GSK217744 Group 1 n=131 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2 n=130 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group n=124 Participants Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Number of Subjects Reporting Any SAEs	0 Participants	2 Participants	0 Participants

Adverse Events

GSK217744 Group 1(Before Protocol Amendment2)

Serious events: 0 serious events

Other events: 85 other events

Deaths: 0 deaths

GSK217744 Group 2(Before Protocol Amendment2)

Serious events: 0 serious events

Other events: 85 other events

Deaths: 0 deaths

Infanrix Hexa Group(Before Protocol Amendment2)

Serious events: 0 serious events

Other events: 96 other events

Deaths: 0 deaths

GSK217744 Group 1(After Protocol Amendment2)

Serious events: 0 serious events

Other events: 118 other events

Deaths: 0 deaths

GSK217744 Group 2(After Protocol Amendment2)

Serious events: 2 serious events

Other events: 103 other events

Deaths: 0 deaths

Infanrix Hexa Group(After Protocol Amendment2)

Serious events: 0 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK217744 Group 1(Before Protocol Amendment2) n=85 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2(Before Protocol Amendment2) n=88 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group(Before Protocol Amendment2) n=99 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 1(After Protocol Amendment2) n=131 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2(After Protocol Amendment2) n=130 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group(After Protocol Amendment2) n=124 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively
Infections and infestations Pneumonia	0.00% 0/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	1.5% 2/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Metabolism and nutrition disorders Dehydration	0.00% 0/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.77% 1/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).

Other adverse events

Other adverse events
Measure	GSK217744 Group 1(Before Protocol Amendment2) n=85 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2(Before Protocol Amendment2) n=88 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group(Before Protocol Amendment2) n=99 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 1(After Protocol Amendment2) n=131 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	GSK217744 Group 2(After Protocol Amendment2) n=130 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Infanrix Hexa Group(After Protocol Amendment2) n=124 participants at risk Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively
Infections and infestations Conjunctivitis	3.5% 3/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	1.1% 1/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	7.1% 7/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Gastrointestinal disorders Diarrhoea	5.9% 5/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	6.8% 6/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	4.0% 4/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	1.5% 2/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	1.5% 2/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	3.2% 4/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Injection site induration	8.2% 7/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	3.4% 3/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	5.1% 5/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	3.1% 4/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.00% 0/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Pyrexia	51.8% 44/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	51.1% 45/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	39.4% 39/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	45.0% 59/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	39.2% 51/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	41.9% 52/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Pain	65.9% 56/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	76.1% 67/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	63.6% 63/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	58.0% 76/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	50.8% 66/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	51.6% 64/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Skin and subcutaneous tissue disorders Erythema	64.7% 55/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	63.6% 56/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	59.6% 59/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	35.9% 47/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	27.7% 36/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	32.3% 40/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Swelling	52.9% 45/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	48.9% 43/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	48.5% 48/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	32.8% 43/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	26.2% 34/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	30.6% 38/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Nervous system disorders Somnolence	63.5% 54/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	53.4% 47/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	47.5% 47/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	39.7% 52/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	30.8% 40/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	32.3% 40/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Metabolism and nutrition disorders Decreased appetite	50.6% 43/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	51.1% 45/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	46.5% 46/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	32.1% 42/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	28.5% 37/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	27.4% 34/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Infections and infestations Nasopharyngitis	4.7% 4/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	2.3% 2/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	5.1% 5/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	9.9% 13/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	6.9% 9/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	6.5% 8/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Infections and infestations Otitis media	7.1% 6/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	12.5% 11/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	11.1% 11/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	2.3% 3/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	2.3% 3/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	1.6% 2/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Infections and infestations Upper respiratory tract infection	7.1% 6/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	8.0% 7/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	9.1% 9/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.76% 1/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.77% 1/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	3.2% 4/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Infections and infestations Gastroenteritis	2.4% 2/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	2.3% 2/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	5.1% 5/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.76% 1/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.77% 1/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	0.81% 1/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Psychiatric disorders Irritability	81.2% 69/85 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	83.0% 73/88 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	74.7% 74/99 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	50.4% 66/131 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	44.6% 58/130 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).	50.0% 62/124 • Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).

Additional Information

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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.
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