Trial Outcomes & Findings for Booster and Catch-up Vaccination With Vaccine GSK1024850A (NCT NCT01030822)

NCT ID: NCT01030822

Last Updated: 2018-09-20

Results Overview

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 282 participants
• Primary outcome timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)
• Results posted on: 2018-09-20

Participant Flow

Participant milestones

Measure	Synflorix 1 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Overall Study STARTED	100	95	87
Overall Study COMPLETED	69	71	61
Overall Study NOT COMPLETED	31	24	26

Reasons for withdrawal

Measure	Synflorix 1 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Overall Study Moved/migrated from study area	6	7	3
Overall Study Withdrawal by Subject	16	13	16
Overall Study Lost to Follow-up	9	4	7

Baseline Characteristics

Booster and Catch-up Vaccination With Vaccine GSK1024850A

Baseline characteristics by cohort

Measure	Synflorix 1 Group n=100 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=95 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=87 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.	Total n=282 Participants Total of all reporting groups
Age, Continuous	12.5 Months STANDARD_DEVIATION 2.74 • n=5 Participants	15.6 Months STANDARD_DEVIATION 1.27 • n=7 Participants	16.1 Months STANDARD_DEVIATION 1.18 • n=5 Participants	14.65 Months STANDARD_DEVIATION 2.49 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	50 Participants n=7 Participants	48 Participants n=5 Participants	137 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	45 Participants n=7 Participants	39 Participants n=5 Participants	145 Participants n=4 Participants

PRIMARY outcome

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)

Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points. Primary results are results one month after booster vaccination (Month 1).

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=71 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B 24 months of age	0.78 µg/mL Interval 0.54 to 1.11	0.9 µg/mL Interval 0.61 to 1.32	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 PRE	0.37 µg/mL Interval 0.29 to 0.48	0.31 µg/mL Interval 0.23 to 0.41	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 Month 1	4.78 µg/mL Interval 3.87 to 5.91	5.98 µg/mL Interval 4.54 to 7.9	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 24 months of age	0.96 µg/mL Interval 0.68 to 1.37	1.37 µg/mL Interval 1.0 to 1.87	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 PRE	0.76 µg/mL Interval 0.58 to 1.0	0.58 µg/mL Interval 0.44 to 0.75	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 Month 1	7.28 µg/mL Interval 5.41 to 9.79	11.56 µg/mL Interval 7.96 to 16.79	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 24 months of age	1.24 µg/mL Interval 0.9 to 1.7	2.29 µg/mL Interval 1.53 to 3.42	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 PRE	0.5 µg/mL Interval 0.4 to 0.63	0.38 µg/mL Interval 0.29 to 0.48	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 Month 1	5.86 µg/mL Interval 4.69 to 7.32	7.2 µg/mL Interval 5.25 to 9.86	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 24 months of age	1.19 µg/mL Interval 0.86 to 1.65	2.03 µg/mL Interval 1.43 to 2.86	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B PRE	0.65 µg/mL Interval 0.5 to 0.85	0.49 µg/mL Interval 0.37 to 0.64	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B Month 1	2.82 µg/mL Interval 2.16 to 3.68	2.98 µg/mL Interval 2.05 to 4.32	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F PRE	1.12 µg/mL Interval 0.92 to 1.38	0.93 µg/mL Interval 0.73 to 1.19	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F Month 1	6.3 µg/mL Interval 4.8 to 8.25	7.89 µg/mL Interval 5.91 to 10.54	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F 24 months of age	1.3 µg/mL Interval 0.96 to 1.76	1.98 µg/mL Interval 1.43 to 2.75	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V PRE	1.2 µg/mL Interval 0.94 to 1.52	0.96 µg/mL Interval 0.74 to 1.25	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V Month 1	8.03 µg/mL Interval 6.03 to 10.69	9.76 µg/mL Interval 7.08 to 13.44	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V 24 months of age	1.7 µg/mL Interval 1.2 to 2.41	2.27 µg/mL Interval 1.64 to 3.14	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 PRE	1.76 µg/mL Interval 1.22 to 2.53	1.52 µg/mL Interval 1.08 to 2.15	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 Month 1	10.18 µg/mL Interval 7.6 to 13.65	11.85 µg/mL Interval 8.15 to 17.22	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 24 months of age	3.02 µg/mL Interval 2.09 to 4.37	4.11 µg/mL Interval 2.98 to 5.67	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C PRE	2.51 µg/mL Interval 1.94 to 3.23	1.55 µg/mL Interval 1.19 to 2.03	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C Month 1	33.39 µg/mL Interval 24.73 to 45.08	42.43 µg/mL Interval 31.48 to 57.2	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C 24 months of age	5.56 µg/mL Interval 3.84 to 8.05	10.04 µg/mL Interval 6.55 to 15.37	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F PRE	1.78 µg/mL Interval 1.34 to 2.36	1.23 µg/mL Interval 0.97 to 1.57	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F Month 1	13.68 µg/mL Interval 9.86 to 18.97	13.64 µg/mL Interval 9.42 to 19.76	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F 24 months of age	2.57 µg/mL Interval 1.81 to 3.65	4.15 µg/mL Interval 2.88 to 5.98	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F PRE	0.73 µg/mL Interval 0.55 to 0.97	0.65 µg/mL Interval 0.48 to 0.89	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F Month 1	5.54 µg/mL Interval 4.02 to 7.63	6.48 µg/mL Interval 4.69 to 8.96	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F 24 months of age	1.3 µg/mL Interval 0.88 to 1.91	1.38 µg/mL Interval 0.96 to 1.98	—

SECONDARY outcome

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=81 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 PRE	0.04 µg/mL Interval 0.03 to 0.04	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 Month 3	2.5 µg/mL Interval 1.93 to 3.24	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 Month 6	1.03 µg/mL Interval 0.82 to 1.29	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1 Month 7	3.32 µg/mL Interval 2.69 to 4.1	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 PRE	0.04 µg/mL Interval 0.03 to 0.05	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 Month 3	5.89 µg/mL Interval 4.23 to 8.22	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 Month 6	2.23 µg/mL Interval 1.85 to 2.69	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4 Month 7	8.22 µg/mL Interval 5.92 to 11.42	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 PRE	0.05 µg/mL Interval 0.04 to 0.06	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 Month 3	2.81 µg/mL Interval 2.2 to 3.58	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 Month 6	1.39 µg/mL Interval 1.13 to 1.7	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5 Month 7	5.32 µg/mL Interval 4.21 to 6.72	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B PRE	0.03 µg/mL Interval 0.03 to 0.04	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B Month 3	0.71 µg/mL Interval 0.53 to 0.95	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B Month 6	0.61 µg/mL Interval 0.47 to 0.78	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B Month 7	1.4 µg/mL Interval 1.04 to 1.88	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F PRE	0.06 µg/mL Interval 0.05 to 0.08	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F Month 3	4.63 µg/mL Interval 3.38 to 6.34	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F Month 6	2.72 µg/mL Interval 2.28 to 3.24	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F Month 7	7.41 µg/mL Interval 5.87 to 9.34	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V PRE	0.04 µg/mL Interval 0.03 to 0.05	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V Month 3	2.09 µg/mL Interval 1.53 to 2.87	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V Month 6	1.74 µg/mL Interval 1.4 to 2.17	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V Month 7	4.88 µg/mL Interval 3.73 to 6.37	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 PRE	0.06 µg/mL Interval 0.05 to 0.08	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 Month 3	5.01 µg/mL Interval 3.75 to 6.69	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 Month 6	2.84 µg/mL Interval 2.25 to 3.57	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14 Month 7	7.59 µg/mL Interval 5.87 to 9.8	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C PRE	0.04 µg/mL Interval 0.03 to 0.05	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C Month 3	29.1 µg/mL Interval 19.86 to 42.64	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C Month 6	12.44 µg/mL Interval 9.16 to 16.91	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C Month 7	75.19 µg/mL Interval 57.69 to 98.01	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F PRE	0.07 µg/mL Interval 0.05 to 0.1	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F Month 3	16.39 µg/mL Interval 11.15 to 24.1	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F Month 6	7.74 µg/mL Interval 5.85 to 10.24	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F Month 7	30.71 µg/mL Interval 23.76 to 39.68	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F PRE	0.04 µg/mL Interval 0.03 to 0.05	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F Month 3	1.13 µg/mL Interval 0.82 to 1.57	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F Month 6	0.85 µg/mL Interval 0.67 to 1.09	—	—
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F Month 7	2.15 µg/mL Interval 1.69 to 2.75	—	—

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB+Hiberix Group

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=90 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=84 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-4	0.76 µg/mL Interval 0.58 to 1.0	0.57 µg/mL Interval 0.45 to 0.72	0.04 µg/mL Interval 0.03 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-1	0.37 µg/mL Interval 0.29 to 0.48	0.3 µg/mL Interval 0.24 to 0.39	0.04 µg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-5	0.5 µg/mL Interval 0.4 to 0.63	0.38 µg/mL Interval 0.31 to 0.47	0.05 µg/mL Interval 0.04 to 0.06
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-6B	0.65 µg/mL Interval 0.5 to 0.85	0.51 µg/mL Interval 0.4 to 0.65	0.03 µg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-7F	1.12 µg/mL Interval 0.92 to 1.38	0.98 µg/mL Interval 0.79 to 1.23	0.06 µg/mL Interval 0.04 to 0.08
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-9V	1.2 µg/mL Interval 0.94 to 1.52	0.98 µg/mL Interval 0.78 to 1.23	0.04 µg/mL Interval 0.03 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-14	1.76 µg/mL Interval 1.22 to 2.53	1.37 µg/mL Interval 1.0 to 1.87	0.06 µg/mL Interval 0.05 to 0.08
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-18C	2.51 µg/mL Interval 1.94 to 3.23	1.61 µg/mL Interval 1.26 to 2.05	0.04 µg/mL Interval 0.03 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-19F	1.78 µg/mL Interval 1.34 to 2.36	1.36 µg/mL Interval 1.1 to 1.68	0.07 µg/mL Interval 0.05 to 0.09
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) Anti-23F	0.73 µg/mL Interval 0.55 to 0.97	0.64 µg/mL Interval 0.49 to 0.85	0.04 µg/mL Interval 0.03 to 0.05

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=87 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=84 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=78 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-1	16.5 Titer Interval 11.2 to 24.3	15.6 Titer Interval 10.5 to 23.0	4.4 Titer Interval 3.9 to 5.0
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-4	70.3 Titer Interval 43.9 to 112.5	102.8 Titer Interval 66.4 to 159.1	6.2 Titer Interval 4.2 to 9.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-5	11.9 Titer Interval 8.9 to 15.9	10.4 Titer Interval 7.8 to 13.7	4.2 Titer Interval 3.8 to 4.7
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-6B	50.2 Titer Interval 30.7 to 82.1	62 Titer Interval 36.5 to 105.5	5.3 Titer Interval 3.9 to 7.0
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-7F	1162.5 Titer Interval 910.0 to 1485.0	1551.1 Titer Interval 1269.4 to 1895.3	1186.4 Titer Interval 588.8 to 2390.7
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-9V	430.4 Titer Interval 310.7 to 596.1	617.6 Titer Interval 477.6 to 798.6	192.6 Titer Interval 93.6 to 396.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-14	206.4 Titer Interval 134.2 to 317.5	166.3 Titer Interval 105.7 to 261.6	13.5 Titer Interval 7.8 to 23.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-18C	30.4 Titer Interval 20.7 to 44.6	23 Titer Interval 15.6 to 34.0	4.8 Titer Interval 3.8 to 6.0
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-19F	43 Titer Interval 29.9 to 61.7	42.4 Titer Interval 29.5 to 60.8	4.2 Titer Interval 3.9 to 4.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) Opsono-23F	157 Titer Interval 83.2 to 296.3	531.1 Titer Interval 280.3 to 1006.4	41.9 Titer Interval 18.8 to 93.2

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=87 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=65 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 PRE	16.5 Titer Interval 11.2 to 24.3	14.3 Titer Interval 9.3 to 22.1	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 Month 1	1138.3 Titer Interval 828.6 to 1563.7	2096.7 Titer Interval 1464.8 to 3001.1	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 24 months of age	69.6 Titer Interval 40.1 to 121.0	173.8 Titer Interval 105.5 to 286.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 PRE	70.3 Titer Interval 43.9 to 112.5	101.6 Titer Interval 62.6 to 164.9	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 Month 1	3368.8 Titer Interval 2618.0 to 4334.9	7202.1 Titer Interval 5336.1 to 9720.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 24 months of age	557.4 Titer Interval 284.0 to 1093.9	2525.6 Titer Interval 1474.5 to 4325.9	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 PRE	11.9 Titer Interval 8.9 to 15.9	9.7 Titer Interval 7.2 to 13.1	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 Month 1	452.7 Titer Interval 353.0 to 580.6	834.6 Titer Interval 610.9 to 1140.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 24 months of age	45.7 Titer Interval 29.6 to 70.7	90.6 Titer Interval 54.8 to 149.8	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B PRE	50.2 Titer Interval 30.7 to 82.1	60 Titer Interval 32.9 to 109.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B Month 1	1556.6 Titer Interval 1090.0 to 2223.0	1781.2 Titer Interval 1042.5 to 3043.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B 24 months of age	241.4 Titer Interval 127.7 to 456.4	287.5 Titer Interval 149.0 to 555.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F PRE	1162.5 Titer Interval 910.0 to 1485.0	1539.1 Titer Interval 1262.9 to 1875.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F Month 1	7814.8 Titer Interval 5984.8 to 10204.3	11064.4 Titer Interval 8182.9 to 14960.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F 24 months of age	2891.2 Titer Interval 1954.4 to 4276.9	5371.9 Titer Interval 3712.4 to 7773.4	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V PRE	430.4 Titer Interval 310.7 to 596.1	704.9 Titer Interval 533.7 to 931.1	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V Month 1	4440 Titer Interval 3305.4 to 5964.2	7870.3 Titer Interval 5634.4 to 10993.4	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V 24 months of age	1926.1 Titer Interval 1316.6 to 2817.9	3504.5 Titer Interval 2501.0 to 4910.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 PRE	206.4 Titer Interval 134.2 to 317.5	184 Titer Interval 109.8 to 308.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 Month 1	2057.1 Titer Interval 1569.6 to 2696.1	4407.5 Titer Interval 3193.2 to 6083.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 24 months of age	668.5 Titer Interval 403.1 to 1108.6	1641.2 Titer Interval 944.2 to 2852.9	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C PRE	30.4 Titer Interval 20.7 to 44.6	22.2 Titer Interval 14.1 to 35.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C Month 1	1889.7 Titer Interval 1429.4 to 2498.1	3643.2 Titer Interval 2572.2 to 5160.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C 24 months of age	233.6 Titer Interval 142.2 to 383.8	1155 Titer Interval 662.0 to 2015.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F PRE	43 Titer Interval 29.9 to 61.7	34.7 Titer Interval 23.4 to 51.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F Month 1	1672.9 Titer Interval 1096.3 to 2552.7	2404.4 Titer Interval 1583.1 to 3651.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F 24 months of age	107.3 Titer Interval 61.4 to 187.6	357.9 Titer Interval 218.9 to 585.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F PRE	157 Titer Interval 83.2 to 296.3	498.2 Titer Interval 231.4 to 1072.9	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F Month 1	3812.3 Titer Interval 2630.8 to 5524.5	5937.2 Titer Interval 3587.6 to 9825.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F 24 months of age	1994.1 Titer Interval 959.7 to 4143.4	3018.5 Titer Interval 1389.0 to 6559.6	—

SECONDARY outcome

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=75 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F Month 7	3808.8 Titer Interval 2689.5 to 5393.9	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 PRE	4.3 Titer Interval 3.9 to 4.8	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 Month 3	76.1 Titer Interval 49.0 to 118.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 Month 6	18.1 Titer Interval 11.5 to 28.4	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-1 Month 7	309.8 Titer Interval 203.0 to 472.9	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 PRE	5.8 Titer Interval 4.0 to 8.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 Month 3	2256.3 Titer Interval 1840.0 to 2766.8	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 Month 6	959.7 Titer Interval 727.2 to 1266.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-4 Month 7	2946.2 Titer Interval 2097.9 to 4137.4	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 PRE	4.2 Titer Interval 3.8 to 4.7	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 Month 3	76.3 Titer Interval 53.3 to 109.3	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 Month 6	24.6 Titer Interval 17.0 to 35.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-5 Month 7	212 Titer Interval 148.9 to 301.7	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B PRE	5.3 Titer Interval 3.9 to 7.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B Month 3	348.2 Titer Interval 165.7 to 731.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B Month 6	201.5 Titer Interval 98.2 to 413.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-6B Month 7	740.5 Titer Interval 419.6 to 1306.8	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F PRE	1106.8 Titer Interval 540.7 to 2265.9	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F Month 3	7462.5 Titer Interval 5653.9 to 9849.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F Month 6	6295.9 Titer Interval 4545.0 to 8721.4	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-7F Month 7	10104 Titer Interval 7377.8 to 13837.4	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V PRE	205.9 Titer Interval 98.7 to 429.4	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V Month 3	5792.5 Titer Interval 4586.3 to 7315.9	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V Month 6	3463.4 Titer Interval 2716.3 to 4416.1	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-9V Month 7	7000 Titer Interval 5265.1 to 9306.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 PRE	12.4 Titer Interval 7.1 to 21.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 Month 3	2359.8 Titer Interval 1576.1 to 3533.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 Month 6	1293.6 Titer Interval 886.8 to 1887.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-14 Month 7	3709.4 Titer Interval 2463.5 to 5585.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C PRE	4.8 Titer Interval 3.8 to 6.1	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C Month 3	2487.5 Titer Interval 1541.2 to 4014.8	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C Month 6	2546.4 Titer Interval 1755.0 to 3694.7	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-18C Month 7	8814.6 Titer Interval 6810.9 to 11407.7	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F PRE	4.2 Titer Interval 3.9 to 4.6	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F Month 3	1768.6 Titer Interval 1120.3 to 2792.0	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-19F Month 6	753.8 Titer Interval 497.3 to 1142.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F PRE	38.7 Titer Interval 17.1 to 87.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F Month 3	3378.1 Titer Interval 2014.8 to 5664.0	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F Month 6	1868.2 Titer Interval 956.9 to 3647.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Opsono-23F Month 7	4357.3 Titer Interval 2246.9 to 8449.8	—	—

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.

Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=84 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) Anti-6A	0.19 µg/mL Interval 0.14 to 0.26	0.22 µg/mL Interval 0.16 to 0.29	0.03 µg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) Anti-19A	0.31 µg/mL Interval 0.21 to 0.45	0.33 µg/mL Interval 0.25 to 0.45	0.06 µg/mL Interval 0.04 to 0.08

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

Antibodies assessed for this outcome measure were those against the cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=70 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A PRE	0.19 µg/mL Interval 0.14 to 0.26	0.19 µg/mL Interval 0.14 to 0.27	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A Month 1	0.82 µg/mL Interval 0.59 to 1.14	0.95 µg/mL Interval 0.63 to 1.44	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A 24 months of age	0.32 µg/mL Interval 0.22 to 0.48	0.36 µg/mL Interval 0.22 to 0.59	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A PRE	0.31 µg/mL Interval 0.21 to 0.45	0.3 µg/mL Interval 0.22 to 0.41	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A Month 1	2.54 µg/mL Interval 1.61 to 4.03	2.87 µg/mL Interval 1.78 to 4.61	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A 24 months of age	0.71 µg/mL Interval 0.45 to 1.14	1.33 µg/mL Interval 0.85 to 2.08	—

SECONDARY outcome

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=81 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A PRE	0.06 µg/mL Interval 0.04 to 0.08	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A Month 3	2.49 µg/mL Interval 1.77 to 3.51	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A PRE	0.03 µg/mL Interval 0.03 to 0.04	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A Month 3	0.35 µg/mL Interval 0.25 to 0.5	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A Month 6	0.33 µg/mL Interval 0.24 to 0.45	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-6A Month 7	0.76 µg/mL Interval 0.53 to 1.09	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A Month 6	1.94 µg/mL Interval 1.44 to 2.61	—	—
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Anti-19A Month 7	7.91 µg/mL Interval 5.62 to 11.13	—	—

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.

OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=86 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=82 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=78 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) Opsono-6A	21.1 Titer Interval 13.2 to 33.6	30.1 Titer Interval 18.4 to 49.3	10.3 Titer Interval 6.3 to 17.0
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) Opsono-19A	9.7 Titer Interval 6.8 to 13.7	7.4 Titer Interval 5.7 to 9.7	4.8 Titer Interval 4.0 to 5.7

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=86 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=63 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A PRE	21.1 Titer Interval 13.2 to 33.6	27.1 Titer Interval 15.7 to 47.0	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A Month 1	168.7 Titer Interval 96.3 to 295.5	262.5 Titer Interval 135.4 to 509.0	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A 24 months of age	62.2 Titer Interval 33.7 to 114.8	96.6 Titer Interval 45.4 to 205.6	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A PRE	9.7 Titer Interval 6.8 to 13.7	7 Titer Interval 5.3 to 9.3	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A Month 1	161.6 Titer Interval 93.7 to 278.5	385.6 Titer Interval 223.4 to 665.5	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A 24 months of age	17.8 Titer Interval 9.8 to 32.1	60 Titer Interval 33.0 to 109.2	—

SECONDARY outcome

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Outcome measures

Measure	Synflorix 1 Group n=75 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A PRE	10.2 Titer Interval 6.1 to 17.1	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A Month 3	324.9 Titer Interval 176.1 to 599.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A Month 6	329 Titer Interval 181.0 to 598.2	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-6A Month 7	616.2 Titer Interval 369.2 to 1028.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A PRE	4.8 Titer Interval 4.0 to 5.8	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A Month 3	506.6 Titer Interval 305.5 to 840.1	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A Month 6	402.1 Titer Interval 248.9 to 649.5	—	—
Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A Opsono-19A Month 7	1770.9 Titer Interval 1190.6 to 2634.0	—	—

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group

Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=90 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=82 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Protein D (Anti-PD) (Persistence)	776.3 EL.U/mL Interval 629.0 to 958.2	618.6 EL.U/mL Interval 488.2 to 783.9	71.6 EL.U/mL Interval 62.3 to 82.2

SECONDARY outcome

Timeframe: Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=89 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=71 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD PRE	776.3 EL.U/mL Interval 629.0 to 958.2	654.7 EL.U/mL Interval 497.9 to 860.9	—
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 1	3704.2 EL.U/mL Interval 2825.6 to 4856.0	5297.6 EL.U/mL Interval 3934.0 to 7133.8	—
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD 24 months of age	1337.3 EL.U/mL Interval 953.8 to 1875.0	2191.9 EL.U/mL Interval 1582.5 to 3036.0	—

SECONDARY outcome

Timeframe: Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix 1 Group n=79 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD PRE	72.5 EL.U/mL Interval 62.9 to 83.7	—	—
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 3	527.7 EL.U/mL Interval 397.4 to 700.9	—	—
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 6	443.2 EL.U/mL Interval 333.1 to 589.6	—	—
Concentrations of Antibodies Against Protein D (Anti-PD) Anti-PD Month 7	1727.2 EL.U/mL Interval 1306.6 to 2283.3	—	—

SECONDARY outcome

Timeframe: Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group

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

Solicited local symptoms assessed include 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 larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Measure	Synflorix 1 Group n=93 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=85 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=82 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	31 Participants	25 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	2 Participants	4 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	16 Participants	12 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	2 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	14 Participants	14 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	4 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group

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

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.

Outcome measures

Measure	Synflorix 1 Group n=92 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=85 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=82 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	5 Participants	4 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	4 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	20 Participants	13 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	19 Participants	13 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irr./Fuss.	19 Participants	9 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irr./Fuss.	1 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irr./Fuss.	15 Participants	9 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of Appetite	14 Participants	9 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of Appetite	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of Appetite	9 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Within 31-day follow-up period (Days 0-30) after vaccination

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

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. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Measure	Synflorix 1 Group n=100 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=95 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=87 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	7 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: After the first vaccination up to study end (from Month 0 to Month 15)

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

SAEs assessed include medical occurrences that result in death, are life- threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.

Outcome measures

Measure	Synflorix 1 Group n=100 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=95 Participants Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=87 Participants Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	0 Participants	1 Participants

Adverse Events

Synflorix 1 Group

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Synflorix 2 Group

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Tritanrix-HepB+Hiberix Group

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix 1 Group n=100 participants at risk Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=95 participants at risk Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=87 participants at risk Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
Nervous system disorders Febrile convulsion	0.00% 0/100 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/95 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	1.1% 1/87 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
Infections and infestations Skin infection	1.0% 1/100 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/95 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/87 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
Infections and infestations Gastroenteritis	1.0% 1/100 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/95 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/87 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
Infections and infestations Urinary tract infection	0.00% 0/100 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	0.00% 0/95 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	1.1% 1/87 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.

Other adverse events

Measure	Synflorix 1 Group n=100 participants at risk Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.	Synflorix 2 Group n=95 participants at risk Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.	Tritanrix-HepB+Hiberix Group n=87 participants at risk Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
General disorders Pain	33.3% 31/93 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	29.4% 25/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	31.7% 26/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Redness	17.2% 16/93 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	14.1% 12/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	13.4% 11/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Swelling	15.1% 14/93 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	16.5% 14/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	19.5% 16/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Drowsiness	5.4% 5/92 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	4.7% 4/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	6.1% 5/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Fever (≥38°C)	21.7% 20/92 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	15.3% 13/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	26.8% 22/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Irritability	20.7% 19/92 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	10.6% 9/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	14.6% 12/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.
General disorders Loss of appetite	15.2% 14/92 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	10.6% 9/85 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.	12.2% 10/82 • Solicited AEs: during the 4 days post-vaccination; Unsolicited AEs: during the 31 days post-vaccination after booster dose in the Synflorix 1 and Synflorix 2 Groups and across doses in the Tritanrix-HepB+Hiberix Group; SAEs: from Month 0 to Month 15.

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