Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose (NCT NCT01171989)

NCT ID: NCT01171989

Last Updated: 2020-01-21

Results Overview

A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 391 participants
• Primary outcome timeframe: At Month 1, post-booster dose
• Results posted on: 2020-01-21

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	GSK2202083A + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Overall Study STARTED	137	133	121
Overall Study COMPLETED	137	133	120
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	GSK2202083A + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

Baseline characteristics by cohort

Measure	GSK2202083A + Synflorix Group n=137 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=121 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Total n=391 Participants Total of all reporting groups
Age, Continuous	13.7 Months STANDARD_DEVIATION 0.71 • n=5 Participants	13.8 Months STANDARD_DEVIATION 0.73 • n=7 Participants	13.7 Months STANDARD_DEVIATION 0.76 • n=5 Participants	13.73 Months STANDARD_DEVIATION 0.73 • n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	82 Participants n=7 Participants	56 Participants n=5 Participants	209 Participants n=4 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	51 Participants n=7 Participants	65 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	137 Participants n=5 Participants	133 Participants n=7 Participants	121 Participants n=5 Participants	391 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster dose

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).

Outcome measures

Measure	GSK2202083A + Synflorix Group n=132 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)	132 Participants	126 Participants	114 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=131 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=124 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)	131 Participants	124 Participants	114 Participants

SECONDARY outcome

Timeframe: At Month 0, before the booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=125 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=113 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seropositive Subjects for Anti-PRP	131 Participants	89 Participants	88 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Anti-PRP, M0	32 Participants	22 Participants	15 Participants
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Anti-PRP, M1	132 Participants	126 Participants	114 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-PRP Antibody Concentrations Anti-PRP, M0	0.601 μg/mL Interval 0.502 to 0.719	0.315 μg/mL Interval 0.252 to 0.394	0.368 μg/mL Interval 0.302 to 0.449
Anti-PRP Antibody Concentrations Anti-PRP, M1	25.449 μg/mL Interval 21.797 to 29.712	24.862 μg/mL Interval 20.188 to 30.619	25.943 μg/mL Interval 21.363 to 31.504

SECONDARY outcome

Timeframe: At Month 0, before the booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=127 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=119 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=104 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seroprotected Subjects Against rSBA-MenC	117 Participants	92 Participants	10 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=131 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=124 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seropositive Subjects for Anti-rSBA-MenC Anti-rSBA-MenC, M0	87 Participants	46 Participants	3 Participants
Number of Seropositive Subjects for Anti-rSBA-MenC Anti-rSBA-MenC, M1	130 Participants	124 Participants	114 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=131 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=124 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-rSBA-MenC Antibody Titres Anti-rSBA-MenC, M0	148.8 Titers Interval 114.4 to 193.5	55.6 Titers Interval 40.8 to 75.6	5.4 Titers Interval 4.5 to 6.6
Anti-rSBA-MenC Antibody Titres Anti-rSBA-MenC, M1	2703.4 Titers Interval 2289.6 to 3192.1	7701.8 Titers Interval 6511.9 to 9109.0	2320.4 Titers Interval 2040.3 to 2638.8

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values Anti-PSC ≥ 0.3 μg/mL, M0	133 Participants	101 Participants	0 Participants
Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values Anti-PSC ≥ 0.3 μg/mL, M1	134 Participants	125 Participants	114 Participants
Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values Anti-PSC ≥ 2 μg/mL, M0	72 Participants	21 Participants	0 Participants
Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values Anti-PSC ≥ 2 μg/mL, M1	129 Participants	125 Participants	114 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-PSC Antibody Concentrations Anti-PSC, M0	1.98 μg/mL Interval 1.69 to 2.31	0.76 μg/mL Interval 0.63 to 0.91	0.15 μg/mL Interval 0.15 to 0.15
Anti-PSC Antibody Concentrations Anti-PSC, M1	6.91 μg/mL Interval 6.21 to 7.69	21.75 μg/mL Interval 18.9 to 25.04	17.7 μg/mL Interval 15.97 to 19.61

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

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

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-D, M0	129 Participants	115 Participants	108 Participants
Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-D, M1	132 Participants	126 Participants	114 Participants
Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-T, M0	133 Participants	118 Participants	111 Participants
Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-T, M1	132 Participants	126 Participants	114 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=134 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-D and Anti-T Antibody Concentrations Anti-D, M0	0.349 IU/mL Interval 0.308 to 0.395	0.316 IU/mL Interval 0.27 to 0.37	0.311 IU/mL Interval 0.274 to 0.354
Anti-D and Anti-T Antibody Concentrations Anti-D, M1	6.166 IU/mL Interval 5.47 to 6.951	7.351 IU/mL Interval 6.63 to 8.15	6.02 IU/mL Interval 5.367 to 6.752
Anti-D and Anti-T Antibody Concentrations Anti-T, M0	0.895 IU/mL Interval 0.808 to 0.992	0.316 IU/mL Interval 0.275 to 0.365	0.567 IU/mL Interval 0.5 to 0.643
Anti-D and Anti-T Antibody Concentrations Anti-T, M1	11.945 IU/mL Interval 10.898 to 13.094	5.351 IU/mL Interval 4.752 to 6.027	11.638 IU/mL Interval 10.398 to 13.025

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=125 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=122 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=111 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 3.3 mIU/mL, M0	123 Participants	120 Participants	104 Participants
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 10 mIU/mL, M0	121 Participants	119 Participants	102 Participants
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 100 mIU/mL, M0	99 Participants	108 Participants	90 Participants
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 3.3 mIU/mL, M1	125 Participants	114 Participants	111 Participants
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 10 mIU/mL, M1	125 Participants	114 Participants	109 Participants
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values Anti-HBs ≥ 100 mIU/mL, M1	123 Participants	113 Participants	109 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=125 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=122 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=111 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-HBs Antibody Concentrations Anti-HBs, M0	295.1 mIU/mL Interval 234.0 to 372.1	387.6 mIU/mL Interval 302.6 to 496.3	330.4 mIU/mL Interval 256.5 to 425.5
Anti-HBs Antibody Concentrations Anti-HBs, M1	6390.7 mIU/mL Interval 5171.5 to 7897.2	8465 mIU/mL Interval 6827.0 to 10496.1	6840.3 mIU/mL Interval 5235.8 to 8936.6

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=113 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=102 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=95 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 1, M0	96 Participants	96 Participants	79 Participants
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 1, M1	113 Participants	99 Participants	94 Participants
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 2, M0	93 Participants	95 Participants	80 Participants
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 2, M1	113 Participants	100 Participants	94 Participants
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 3, M0	94 Participants	94 Participants	80 Participants
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 Anti-polio 3, M1	113 Participants	100 Participants	95 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=113 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=102 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=95 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 1, M0	35.1 Titers Interval 27.8 to 44.4	48.3 Titers Interval 37.3 to 62.6	37 Titers Interval 28.5 to 48.0
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 1, M1	870.5 Titers Interval 721.5 to 1050.2	1203 Titers Interval 982.3 to 1473.2	896.7 Titers Interval 739.1 to 1088.0
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 2, M0	34.9 Titers Interval 27.6 to 44.2	46.2 Titers Interval 35.2 to 60.8	38.2 Titers Interval 29.2 to 50.1
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 2, M1	1179.1 Titers Interval 979.3 to 1419.7	1483.6 Titers Interval 1217.2 to 1808.5	1143.8 Titers Interval 929.7 to 1407.1
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 3, M0	43.7 Titers Interval 34.0 to 56.1	51.6 Titers Interval 39.6 to 67.1	48.5 Titers Interval 36.3 to 64.7
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-polio 3, M1	1493.3 Titers Interval 1195.0 to 1866.0	1832.9 Titers Interval 1507.9 to 2228.1	1416.8 Titers Interval 1157.1 to 1734.8

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	GSK2202083A + Synflorix Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, M0	98 Participants	97 Participants	84 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT, M1	133 Participants	126 Participants	114 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, M0	131 Participants	122 Participants	111 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA, M1	132 Participants	126 Participants	114 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, M0	100 Participants	109 Participants	94 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN, M1	132 Participants	126 Participants	113 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1, before and one month after booster dose

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=126 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=114 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M0	7.7 EL.U/mL Interval 6.7 to 8.8	8.9 EL.U/mL Interval 7.7 to 10.2	7.1 EL.U/mL Interval 6.2 to 8.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M1	50.6 EL.U/mL Interval 45.1 to 56.7	66.3 EL.U/mL Interval 58.6 to 75.0	61.8 EL.U/mL Interval 53.7 to 71.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M0	24.3 EL.U/mL Interval 21.0 to 28.2	30.4 EL.U/mL Interval 26.2 to 35.4	25.7 EL.U/mL Interval 22.1 to 29.7
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M1	265.3 EL.U/mL Interval 235.3 to 299.0	339.6 EL.U/mL Interval 300.2 to 384.1	325.2 EL.U/mL Interval 284.7 to 371.4
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M0	8.8 EL.U/mL Interval 7.5 to 10.3	12.7 EL.U/mL Interval 10.9 to 14.9	11 EL.U/mL Interval 9.3 to 13.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M1	216.8 EL.U/mL Interval 183.7 to 255.8	319.8 EL.U/mL Interval 275.6 to 371.2	277.9 EL.U/mL Interval 233.1 to 331.4

SECONDARY outcome

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

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.

Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=136 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=120 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Any Solicited Local Symptoms Any Pain	44 Participants	68 Participants	58 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	69 Participants	77 Participants	69 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	50 Participants	58 Participants	50 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.

Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=136 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=120 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	40 Participants	39 Participants	39 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability	65 Participants	65 Participants	66 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	31 Participants	32 Participants	43 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature (Axillary)	34 Participants	30 Participants	31 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster period

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

An unsolicited AE was 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.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=137 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=121 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Unsolicited Adverse Events (AEs)	45 Participants	29 Participants	35 Participants

SECONDARY outcome

Timeframe: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)

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

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	GSK2202083A + Synflorix Group n=137 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=121 Participants Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects With Serious Adverse Events (SAEs)	3 Participants	2 Participants	2 Participants

Adverse Events

GSK2202083A + Synflorix Group

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

Infanrix Hexa/Menjugate Group

Serious events: 2 serious events

Other events: 114 other events

Deaths: 0 deaths

Infanrix Hexa/NeisVac-C + Synflorix Group

Serious events: 2 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK2202083A + Synflorix Group n=137 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=121 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
Injury, poisoning and procedural complications Thermal burn	1.5% 2/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Gastrointestinal disorders Diarrhoea	0.73% 1/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.83% 1/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.75% 1/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.83% 1/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Pneumonia	0.00% 0/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.75% 1/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.83% 1/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Bronchopneumonia	0.73% 1/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Gastroenteritis	0.73% 1/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Upper respiratory tract infection	0.00% 0/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.75% 1/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	0.00% 0/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).

Other adverse events

Measure	GSK2202083A + Synflorix Group n=137 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/Menjugate Group n=133 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.	Infanrix Hexa/NeisVac-C + Synflorix Group n=121 participants at risk Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
General disorders Pain	32.4% 44/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	51.1% 68/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	48.3% 58/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Redness	50.7% 69/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	57.9% 77/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	57.5% 69/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Swelling	36.8% 50/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	43.6% 58/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	41.7% 50/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Drowsiness	29.4% 40/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	29.3% 39/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	32.5% 39/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Irritability	47.8% 65/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	48.9% 65/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	55.0% 66/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Loss of appetite	22.8% 31/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	24.1% 32/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	35.8% 43/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
General disorders Fever	25.0% 34/136 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	22.6% 30/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	25.8% 31/120 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Upper respiratory tract infection (unsolicited)	4.4% 6/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	8.3% 11/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	5.0% 6/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Rhinitis	6.6% 9/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	3.0% 4/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	6.6% 8/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).
Infections and infestations Nasopharyngitis	5.1% 7/137 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	1.5% 2/133 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).	3.3% 4/121 • Solicited local and general symptoms: during the 8-day (Days 0- 7) post-booster vaccination. Unsolicited adverse events: during the 31-day (Days 0- 30) post-booster vaccination. Serious adverse events: entire booster period (from Month 0 up to Month 1).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER