Trial Outcomes & Findings for Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™ (NCT NCT00678301)

NCT ID: NCT00678301

Last Updated: 2019-11-15

Results Overview

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 365 participants
• Primary outcome timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
• Results posted on: 2019-11-15

Participant Flow

At screening, the following steps occurred: check for inclusion/exclusion criteria, contraindications/ precautions, medical and vaccination history of the subjects and signing or thumb-printing informed consent forms.

Among 365 enrolled participants, 8 were not administered any study vaccine and hence were not considered as starting the study.

Participant milestones

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Overall Study STARTED	239	118
Overall Study COMPLETED	231	116
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Overall Study Non-compliance with study procedures	0	1
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	4	0
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

Baseline characteristics by cohort

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.	Total n=357 Participants Total of all reporting groups
Age, Continuous	7.1 Weeks STANDARD_DEVIATION 1.15 • n=5 Participants	7 Weeks STANDARD_DEVIATION 1.18 • n=7 Participants	7.07 Weeks STANDARD_DEVIATION 1.16 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	62 Participants n=7 Participants	181 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	56 Participants n=7 Participants	176 Participants n=5 Participants
Race/Ethnicity, Customized African heritage/African American	239 Participants n=5 Participants	118 Participants n=7 Participants	357 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1	2.69 μg/mL Interval 2.42 to 2.99	0.03 μg/mL Interval 0.03 to 0.03
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4	3.44 μg/mL Interval 3.06 to 3.87	0.03 μg/mL Interval 0.03 to 0.03
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5	4.17 μg/mL Interval 3.75 to 4.63	0.03 μg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B	0.95 μg/mL Interval 0.76 to 1.2	0.03 μg/mL Interval 0.03 to 0.03
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F	3.33 μg/mL Interval 2.99 to 3.71	0.03 μg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V	2.39 μg/mL Interval 2.06 to 2.76	0.04 μg/mL Interval 0.03 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14	3.8 μg/mL Interval 3.24 to 4.46	0.14 μg/mL Interval 0.11 to 0.17
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C	10.01 μg/mL Interval 8.49 to 11.8	0.03 μg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F	7.65 μg/mL Interval 6.55 to 8.93	0.08 μg/mL Interval 0.07 to 0.1
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F	1.1 μg/mL Interval 0.91 to 1.33	0.03 μg/mL Interval 0.03 to 0.04

PRIMARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Antibody Concentrations Against Protein D (Anti-PD Antibodies)	3791.8 EL.U/mL Interval 3448.4 to 4169.3	85.4 EL.U/mL Interval 71.8 to 101.5

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=108 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-6A	0.09 μg/mL Interval 0.08 to 0.11	0.04 μg/mL Interval 0.04 to 0.05
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-19A	0.15 μg/mL Interval 0.13 to 0.18	0.06 μg/mL Interval 0.05 to 0.07

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=105 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=56 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-1	83 Titers Interval 61.7 to 111.7	5 Titers Interval 3.8 to 6.4
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-4	892.5 Titers Interval 759.4 to 1049.0	4.6 Titers Interval 3.9 to 5.5
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-5	82.7 Titers Interval 65.4 to 104.4	4.5 Titers Interval 3.8 to 5.2
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-6B	538.6 Titers Interval 346.0 to 838.3	5.7 Titers Interval 4.1 to 7.9
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-7F	2733 Titers Interval 2188.3 to 3413.3	31.5 Titers Interval 15.5 to 64.0
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-9V	1023.7 Titers Interval 784.8 to 1335.2	8.4 Titers Interval 5.8 to 12.4
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-14	1079.2 Titers Interval 776.0 to 1500.9	8.9 Titers Interval 5.7 to 14.1
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-18C	617.6 Titers Interval 495.3 to 770.0	4.4 Titers Interval 3.8 to 5.2
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-19F	358.3 Titers Interval 269.9 to 475.5	4.6 Titers Interval 3.8 to 5.7
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes OPA-23F	881.8 Titers Interval 615.0 to 1264.4	6.6 Titers Interval 4.2 to 10.3

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=105 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=56 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes OPA-6A	14.1 Titres Interval 9.4 to 21.2	6.1 Titres Interval 4.4 to 8.7
Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes OPA-19A	11 Titres Interval 8.3 to 14.6	4.3 Titres Interval 4.0 to 4.6

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-1	217 Participants	14 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-4	217 Participants	12 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-5	217 Participants	18 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B	196 Participants	15 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F	217 Participants	19 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V	213 Participants	31 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-14	217 Participants	91 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C	216 Participants	23 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F	217 Participants	73 Participants
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F	207 Participants	23 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-1	217 Participants	2 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-4	217 Participants	3 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-5	217 Participants	4 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-6B	178 Participants	2 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-7F	216 Participants	2 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-9V	211 Participants	11 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-14	215 Participants	40 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-18C	216 Participants	4 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-19F	214 Participants	25 Participants
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes Anti-23F	190 Participants	3 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=108 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-6A	152 Participants	36 Participants
Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-19A	176 Participants	49 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=108 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-6A	56 Participants	8 Participants
Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) Anti-19A	95 Participants	15 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=217 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)	217 Participants	34 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=105 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=56 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-1	92 Participants	3 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-4	105 Participants	3 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-5	100 Participants	2 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-6B	88 Participants	5 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-7F	105 Participants	21 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-9V	103 Participants	13 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-14	100 Participants	13 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-18C	103 Participants	2 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-19F	101 Participants	2 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes OPA-23F	97 Participants	5 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=105 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=56 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes OPA-6A	31 Participants	6 Participants
Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes OPA-19A	39 Participants	3 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=111 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations	111.9 EL.U/mL Interval 102.0 to 122.7	124.9 EL.U/mL Interval 111.7 to 139.7

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=111 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)	110 Participants	111 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per milliliter (IU/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-D	4.103 IU/mL Interval 3.527 to 4.773	3.13 IU/mL Interval 2.731 to 3.588
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-T	6.484 IU/mL Interval 5.511 to 7.628	4.588 IU/mL Interval 3.88 to 5.426

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A subject seroprotected against D/TT antigens was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens Anti-T	110 Participants	112 Participants
Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens Anti-D	110 Participants	112 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations	18.461 μg/mL Interval 14.256 to 23.907	10.137 μg/mL Interval 7.515 to 13.673

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)	110 Participants	111 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=110 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=112 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens	107 Participants	102 Participants

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=91 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=96 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations	1835.1 mIU/mL Interval 1384.0 to 2433.2	1485.5 mIU/mL Interval 1198.7 to 1840.9

SECONDARY outcome

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine

Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=91 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=96 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs). Anti-HBs ≥ 10 mIU/mL	89 Participants	96 Participants
Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs). Anti-HBs ≥ 100 mIU/mL	89 Participants	94 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Population: The Total Vaccinated Cohort included all evaluable subjects.

Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Pain	8 Participants	3 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Redness	57 Participants	30 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Swelling	173 Participants	83 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Grade 3 Swelling	22 Participants	11 Participants
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms Any Pain	234 Participants	112 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Population: The Total Vaccinated Cohort included all evaluable subjects.

Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Any Drowsiness	24 Participants	12 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	0 Participants	0 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Any Fever (Rectally)	207 Participants	105 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Rectally)	1 Participants	0 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Any Irritability	192 Participants	88 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	6 Participants	2 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Any Loss of appetite	37 Participants	15 Participants
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Population: The Total Vaccinated Cohort included all evaluable subjects.

The cut-off for the assay was > 39.0°C.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off	40 Participants	13 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines

Population: The Total Vaccinated Cohort included all evaluable subjects.

An AE is 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. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Outcome measures

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects With Unsolicited Adverse Events (AEs)	176 Participants	92 Participants

SECONDARY outcome

Timeframe: Throughout the entire study period, from Month 0 to Month 3

Population: The Total Vaccinated Cohort included all evaluable subjects.

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	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 Participants Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 Participants Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Number of Subjects With Serious Adverse Events (SAEs)	5 Participants	0 Participants

Adverse Events

Synflorix™ + Zilbrix™ Hib + Polio Sabin™

Serious events: 5 serious events

Other events: 238 other events

Deaths: 0 deaths

Zilbrix™ Hib + Polio Sabin™

Serious events: 0 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 participants at risk Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 participants at risk Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Vascular disorders Bronchopneumonia	1.7% 4/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	0.00% 0/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Vascular disorders Haematoma	0.42% 1/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	0.00% 0/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Nervous system disorders Febrile convulsion	0.42% 1/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	0.00% 0/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Malaria	0.42% 1/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	0.00% 0/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3

Other adverse events

Measure	Synflorix™ + Zilbrix™ Hib + Polio Sabin™ n=239 participants at risk Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.	Zilbrix™ Hib + Polio Sabin™ n=118 participants at risk Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	34.7% 83/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	39.0% 46/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Eye disorders Conjunctivitis	14.6% 35/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	13.6% 16/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Pain	97.9% 234/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	94.9% 112/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Redness	23.8% 57/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	25.4% 30/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Swelling	72.4% 173/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	70.3% 83/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Drowsiness	10.0% 24/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	10.2% 12/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Fever (rectal temperature ≥ 38.5°C)	86.6% 207/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	89.0% 105/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Irritability	80.3% 192/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	74.6% 88/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Loss of appetite	15.5% 37/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	12.7% 15/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Injection site erosion	0.42% 1/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	5.1% 6/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
General disorders Injection site induration	9.2% 22/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	16.9% 20/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Gastrointestinal disorders Abdominal distension	18.0% 43/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	18.6% 22/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Gastrointestinal disorders Gastrointestinal disorder	10.5% 25/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	12.7% 15/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Gastrointestinal disorders Stomatitis	5.4% 13/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	3.4% 4/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Bronchitis	5.0% 12/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	5.1% 6/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Ear infection	17.6% 42/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	17.8% 21/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Gastroenteritis	25.5% 61/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	27.1% 32/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Pharyngitis	5.9% 14/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	4.2% 5/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Respiratory tract infection	7.1% 17/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	9.3% 11/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Rhinitis	35.6% 85/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	35.6% 42/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Skin infection	6.7% 16/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	13.6% 16/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3
Infections and infestations Urinary tract infection	1.3% 3/239 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3	6.8% 8/118 • Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3

Additional Information

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