Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers (NCT NCT01106092)

NCT ID: NCT01106092

Last Updated: 2019-10-01

Results Overview

Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 312 participants
• Primary outcome timeframe: One month after booster vaccination (At Month 1)
• Results posted on: 2019-10-01

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	GSK2036874A Group 1 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Study STARTED	78	78	78	78
Overall Study COMPLETED	78	78	78	77
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Measure	GSK2036874A Group 1 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

Baseline characteristics by cohort

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.	Total n=312 Participants Total of all reporting groups
Age, Continuous	17.4 Months STANDARD_DEVIATION 3.81 • n=5 Participants	18 Months STANDARD_DEVIATION 2.96 • n=7 Participants	17.7 Months STANDARD_DEVIATION 3.38 • n=5 Participants	17.5 Months STANDARD_DEVIATION 3.59 • n=4 Participants	17.65 Months STANDARD_DEVIATION 3.44 • n=21 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	31 Participants n=7 Participants	35 Participants n=5 Participants	40 Participants n=4 Participants	143 Participants n=21 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	47 Participants n=7 Participants	43 Participants n=5 Participants	38 Participants n=4 Participants	169 Participants n=21 Participants
Race/Ethnicity, Customized Asian-South East Asian heritage	78 Participants n=5 Participants	78 Participants n=7 Participants	78 Participants n=5 Participants	78 Participants n=4 Participants	312 Participants n=21 Participants

PRIMARY outcome

Timeframe: One month after booster vaccination (At Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 1	78 Participants	77 Participants	78 Participants	77 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 2	77 Participants	78 Participants	78 Participants	77 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 3	77 Participants	77 Participants	78 Participants	77 Participants

PRIMARY outcome

Timeframe: Prior to booster vaccination (At Month 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 1	321.1 Titers Interval 231.2 to 446.0	219.1 Titers Interval 144.0 to 333.6	296.6 Titers Interval 205.1 to 428.8	296.9 Titers Interval 213.9 to 412.1
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 2	186.8 Titers Interval 140.1 to 249.2	152.2 Titers Interval 111.8 to 207.3	183.4 Titers Interval 146.4 to 229.7	148.0 Titers Interval 112.4 to 194.9
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 3	74.5 Titers Interval 56.0 to 99.0	82.1 Titers Interval 62.1 to 108.6	102.1 Titers Interval 77.6 to 134.4	79.1 Titers Interval 57.9 to 108.1

PRIMARY outcome

Timeframe: One month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 3	2820 Titers Interval 2129.9 to 3733.9	2217.7 Titers Interval 1654.0 to 2973.4	1915.8 Titers Interval 1498.1 to 2449.8	3626.4 Titers Interval 2618.2 to 5022.9
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 1	2218.4 Titers Interval 1786.3 to 2755.1	1486.7 Titers Interval 1065.9 to 2073.5	1245.1 Titers Interval 1007.2 to 1539.2	3760.2 Titers Interval 2973.7 to 4754.7
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 2	1598.8 Titers Interval 1293.5 to 1976.3	1056.4 Titers Interval 841.5 to 1326.1	966.5 Titers Interval 779.5 to 1198.3	2883.2 Titers Interval 2275.2 to 3653.8

SECONDARY outcome

Timeframe: One month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 Anti-polio 1	70 Participants	64 Participants	60 Participants	69 Participants
Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 Anti-polio 2	68 Participants	66 Participants	70 Participants	72 Participants
Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 Anti-polio 3	74 Participants	74 Participants	73 Participants	75 Participants

SECONDARY outcome

Timeframe: Prior to booster vaccination (At Month 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 1	76 Participants	70 Participants	74 Participants	75 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 2	77 Participants	75 Participants	78 Participants	74 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Anti-polio 3	74 Participants	76 Participants	76 Participants	70 Participants

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-D, M0	69 Participants	69 Participants	69 Participants	65 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-D, M1	78 Participants	78 Participants	78 Participants	77 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-T, M0	78 Participants	77 Participants	77 Participants	76 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-T, M1	78 Participants	78 Participants	78 Participants	77 Participants

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-D and Anti-T Antibody Concentrations Anti-D, M0	0.301 IU/mL Interval 0.237 to 0.382	0.331 IU/mL Interval 0.258 to 0.424	0.330 IU/mL Interval 0.264 to 0.412	0.374 IU/mL Interval 0.276 to 0.508
Anti-D and Anti-T Antibody Concentrations Anti-D, M1	6.519 IU/mL Interval 5.46 to 7.783	7.687 IU/mL Interval 6.112 to 9.669	8.659 IU/mL Interval 7.132 to 10.514	6.807 IU/mL Interval 5.231 to 8.858
Anti-D and Anti-T Antibody Concentrations Anti-T, M0	0.776 IU/mL Interval 0.639 to 0.942	0.766 IU/mL Interval 0.622 to 0.944	0.833 IU/mL Interval 0.668 to 1.038	0.932 IU/mL Interval 0.756 to 1.149
Anti-D and Anti-T Antibody Concentrations Anti-T, M1	26.12 IU/mL Interval 22.65 to 30.121	31.047 IU/mL Interval 25.954 to 37.139	31.054 IU/mL Interval 26.837 to 35.934	24.402 IU/mL Interval 21.042 to 28.298

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) Anti-HBs ≥ 3.3 mIU/mL, M1	78 Participants	77 Participants	78 Participants	77 Participants
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) Anti-HBs ≥ 10 mIU/mL, M0	64 Participants	67 Participants	62 Participants	70 Participants
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) Anti-HBs ≥ 3.3 mIU/mL, M0	71 Participants	70 Participants	73 Participants	73 Participants
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) Anti-HBs ≥ 10 mIU/mL, M1	77 Participants	77 Participants	78 Participants	77 Participants

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

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

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-HBs Antibody Concentrations Anti-HBs, M0	59.9 mIU/mL Interval 40.3 to 89.1	46.9 mIU/mL Interval 32.8 to 67.2	61.9 mIU/mL Interval 42.2 to 91.0	88.5 mIU/mL Interval 60.7 to 129.0
Anti-HBs Antibody Concentrations Anti-HBs, M1	2713.4 mIU/mL Interval 1846.9 to 3986.2	2395.1 mIU/mL Interval 1630.0 to 3519.4	3992.8 mIU/mL Interval 2747.2 to 5803.1	3484.3 mIU/mL Interval 2452.2 to 4950.8

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.

Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) Anti-PRP, M0	28 Participants	27 Participants	30 Participants	35 Participants
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) Anti-PRP, M1	77 Participants	76 Participants	71 Participants	76 Participants

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-PRP Antibody Concentrations Anti-PRP, M0	0.134 μg/mL Interval 0.109 to 0.166	0.137 μg/mL Interval 0.11 to 0.172	0.152 μg/mL Interval 0.118 to 0.197	0.171 μg/mL Interval 0.13 to 0.226
Anti-PRP Antibody Concentrations Anti-PRP, M1	2.871 μg/mL Interval 1.797 to 4.587	2.243 μg/mL Interval 1.52 to 3.31	1.575 μg/mL Interval 1.065 to 2.33	3.305 μg/mL Interval 2.373 to 4.603

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	GSK2036874A Group 1 n=76 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) Anti-BPT, M0	50 Participants	50 Participants	51 Participants	49 Participants
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) Anti-BPT, M1	76 Participants	73 Participants	77 Participants	75 Participants

SECONDARY outcome

Timeframe: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Outcome measures

Measure	GSK2036874A Group 1 n=76 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Anti-BPT Antibody Concentrations Anti-BPT, M0	19.6 EL.U/mL Interval 16.4 to 23.6	20.1 EL.U/mL Interval 16.5 to 24.5	18.9 EL.U/mL Interval 15.9 to 22.4	19.5 EL.U/mL Interval 16.0 to 23.9
Anti-BPT Antibody Concentrations Anti-BPT, M1	161.8 EL.U/mL Interval 143.6 to 182.3	182.9 EL.U/mL Interval 158.0 to 211.9	211 EL.U/mL Interval 190.1 to 234.2	194.7 EL.U/mL Interval 170.6 to 222.4

SECONDARY outcome

Timeframe: One month after booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.

Outcome measures

Measure	GSK2036874A Group 1 n=74 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=74 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=77 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=75 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Subjects With a Booster Response for Anti-BPT	72 Participants	72 Participants	77 Participants	72 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Subjects With Any Solicited Local Symptoms Any Pain	67 Participants	65 Participants	66 Participants	68 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	28 Participants	29 Participants	35 Participants	35 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	33 Participants	32 Participants	36 Participants	35 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	43 Participants	42 Participants	46 Participants	41 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability	53 Participants	60 Participants	57 Participants	65 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	33 Participants	36 Participants	36 Participants	38 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature (Axillary)	59 Participants	60 Participants	57 Participants	63 Participants

SECONDARY outcome

Timeframe: During the 31-day (Day 0-Day 30) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	30 Participants	44 Participants	30 Participants	40 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	GSK2036874A Group 1 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 Participants Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	3 Participants	2 Participants	1 Participants

Adverse Events

GSK2036874A Group 1

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

GSK2036874A Group 2

Serious events: 3 serious events

Other events: 74 other events

Deaths: 0 deaths

GSK2036874A Group 3

Serious events: 2 serious events

Other events: 76 other events

Deaths: 0 deaths

Zilbrix/Hib/Poliorix Group

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK2036874A Group 1 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Nervous system disorders Febrile convulsion	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	3.8% 3/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Infections and infestations Pneumonia	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Infections and infestations Urinary tract infection	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).

Other adverse events

Measure	GSK2036874A Group 1 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 2 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.	GSK2036874A Group 3 n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.	Zilbrix/Hib/Poliorix Group n=78 participants at risk Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Respiratory, thoracic and mediastinal disorders Cough	6.4% 5/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	12.8% 10/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	11.5% 9/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	10.3% 8/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Pain	85.9% 67/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	83.3% 65/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	84.6% 66/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	87.2% 68/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Redness	35.9% 28/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	37.2% 29/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	44.9% 35/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	44.9% 35/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Swelling	42.3% 33/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	41.0% 32/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	46.2% 36/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	44.9% 35/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Drowsiness	55.1% 43/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	53.8% 42/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	59.0% 46/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	52.6% 41/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Fever	75.6% 59/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	76.9% 60/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	73.1% 57/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	80.8% 63/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Irritability	67.9% 53/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	76.9% 60/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	73.1% 57/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	83.3% 65/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
General disorders Loss of appetite	42.3% 33/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	46.2% 36/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	46.2% 36/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	48.7% 38/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Infections and infestations Nasopharyngitis	3.8% 3/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	15.4% 12/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	14.1% 11/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	16.7% 13/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Infections and infestations Upper respiratory tract infection	11.5% 9/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	15.4% 12/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	6.4% 5/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	11.5% 9/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Infections and infestations Conjunctivitis bacterial	1.3% 1/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	5.1% 4/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).	0.00% 0/78 • Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 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