Trial Outcomes & Findings for Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine (NCT NCT00624819)

Results Overview

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

524 participants

Primary outcome timeframe

At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Results posted on

2021-01-27

Participant Flow

Primed groups included Synflorix vaccinated subjects in study 10PN-PD-DIT-007. The Unprimed Group, added only in Year 4,included subjects unprimed with any pneumococcal vaccine age-matched with primed groups. The study included 3 sub-studies (111345, 111346, 111347) corresponding to Year 1, 2 and 4 time points post Dose 1 in Study 10PN-PD-DIT-001.

At screening, subjects with previous participation in 10PN-PD-DIT-007 study were invited to join this study. Informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.

Participant milestones

Participant milestones
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Follow-up Period: Year 1 STARTED	391	31	102	0
Follow-up Period: Year 1 COMPLETED	391	31	102	0
Follow-up Period: Year 1 NOT COMPLETED	0	0	0	0
Follow-up Period: Year 2 STARTED	370	31	96	0
Follow-up Period: Year 2 COMPLETED	370	31	96	0
Follow-up Period: Year 2 NOT COMPLETED	0	0	0	0
Follow-up Period: Year 4 STARTED	264	20	65	100
Follow-up Period: Year 4 COMPLETED	263	19	64	100
Follow-up Period: Year 4 NOT COMPLETED	1	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Follow-up Period: Year 4 Parents decision	0	0	1	0
Follow-up Period: Year 4 Lost to Follow-up	1	1	0	0

Baseline Characteristics

Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=391 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.	Total n=624 Participants Total of all reporting groups
Age, Continuous	67.4 Months STANDARD_DEVIATION 0.84 • n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	67.1 Months STANDARD_DEVIATION 0.97 • n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	67.3 Months STANDARD_DEVIATION 0.89 • n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	65.4 Months STANDARD_DEVIATION 1.31 • n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	66.9 Months STANDARD_DEVIATION 1.28 • n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Sex: Female, Male Female	139 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	10 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	35 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	53 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	237 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Sex: Female, Male Male	125 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	10 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	30 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	47 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	212 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White - caucasia/ european heritage	386 Participants n=391 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	31 Participants n=31 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	102 Participants n=102 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	519 Participants n=524 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White arabic/ north african heritage	4 Participants n=391 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=31 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	4 Participants n=102 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	8 Participants n=524 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized Other, not specified	0 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	1 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	1 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White - Caucasian / European heritage	365 Participants n=370 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	31 Participants n=31 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	96 Participants n=96 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	492 Participants n=497 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White - Arabic / North African heritage	4 Participants n=370 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=31 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=96 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	4 Participants n=497 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White - Caucasian/ European heritage	261 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	20 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	65 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	98 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	444 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized White - Arabic/North African heritage	3 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	3 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.
Race/Ethnicity, Customized Asian - Central/South Asian heritage	0 Participants n=264 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=20 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	0 Participants n=65 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	1 Participants n=100 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.	1 Participants n=449 Participants • Demographic characteristics data was presented for each Follow-up Period (Year 1, 2 and 4). Unprimed Group was added only in Year 4 of the study.

PRIMARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=389 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-14 antibodies, Y1	387 Participants	31 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-18C antibodies, Y1	384 Participants	31 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-1 antibodies, Y1	372 Participants	7 Participants	99 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-4 antibodies, Y1	384 Participants	31 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-5 antibodies, Y1	386 Participants	19 Participants	101 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6B antibodies, Y1	384 Participants	31 Participants	100 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-7F antibodies, Y1	387 Participants	17 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-9V antibodies, Y1	388 Participants	17 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19F antibodies, Y1	387 Participants	31 Participants	102 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-23F antibodies, Y1	386 Participants	31 Participants	102 Participants	—

PRIMARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-4 antibodies, Y2	356 Participants	30 Participants	96 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-5 antibodies, Y2	362 Participants	21 Participants	95 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-14 antibodies, Y2	367 Participants	30 Participants	96 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19F antibodies, Y2	368 Participants	30 Participants	95 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-23F antibodies, Y2	357 Participants	30 Participants	95 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-1 antibodies, Y2	354 Participants	18 Participants	90 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6B antibodies, Y2	355 Participants	30 Participants	95 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-7F antibodies, Y2	367 Participants	19 Participants	95 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-9V antibodies, Y2	362 Participants	30 Participants	96 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-18C antibodies, Y2	365 Participants	30 Participants	96 Participants	—

PRIMARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=75 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, Y4	238 Participants	14 Participants	71 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, Y4	255 Participants	19 Participants	75 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, Y4	263 Participants	19 Participants	75 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, Y4	238 Participants	18 Participants	72 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, Y4	257 Participants	19 Participants	73 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, Y4	258 Participants	19 Participants	74 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, Y4	260 Participants	13 Participants	73 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, Y4	256 Participants	19 Participants	73 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, Y4	260 Participants	19 Participants	75 Participants	—
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, Y4	254 Participants	19 Participants	74 Participants	—

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL).The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=389 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-1 antibodies, Y1	0.29 µg/mL Interval 0.27 to 0.32	0.04 µg/mL Interval 0.03 to 0.06	0.26 µg/mL Interval 0.21 to 0.31	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-4 antibodies, Y1	0.5 µg/mL Interval 0.45 to 0.55	0.59 µg/mL Interval 0.46 to 0.75	1.01 µg/mL Interval 0.84 to 1.21	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-5 antibodies, Y1	0.59 µg/mL Interval 0.54 to 0.65	0.07 µg/mL Interval 0.05 to 0.11	0.42 µg/mL Interval 0.35 to 0.52	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6B antibodies, Y1	0.52 µg/mL Interval 0.45 to 0.6	0.98 µg/mL Interval 0.63 to 1.53	0.54 µg/mL Interval 0.42 to 0.69	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-7F antibodies, Y1	0.71 µg/mL Interval 0.66 to 0.77	0.08 µg/mL Interval 0.05 to 0.13	0.83 µg/mL Interval 0.7 to 0.99	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-9V antibodies, Y1	0.79 µg/mL Interval 0.71 to 0.89	0.93 µg/mL Interval 0.7 to 1.22	0.58 µg/mL Interval 0.49 to 0.68	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-14 antibodies, Y1	1.27 µg/mL Interval 1.12 to 1.44	1.79 µg/mL Interval 1.29 to 2.48	1.47 µg/mL Interval 1.17 to 1.85	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-18C antibodies, Y1	0.88 µg/mL Interval 0.81 to 0.96	0.91 µg/mL Interval 0.71 to 1.16	0.82 µg/mL Interval 0.69 to 0.98	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19F antibodies, Y1	1.43 µg/mL Interval 1.27 to 1.6	0.83 µg/mL Interval 0.47 to 1.45	1.51 µg/mL Interval 1.19 to 1.92	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-23F antibodies, Y1	0.61 µg/mL Interval 0.54 to 0.69	1.18 µg/mL Interval 0.84 to 1.68	0.7 µg/mL Interval 0.56 to 0.88	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-4 antibodies, Y2	0.27 µg/mL Interval 0.24 to 0.3	0.3 µg/mL Interval 0.24 to 0.38	0.52 µg/mL Interval 0.43 to 0.64	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-5 antibodies, Y2	0.41 µg/mL Interval 0.37 to 0.45	0.09 µg/mL Interval 0.06 to 0.13	0.33 µg/mL Interval 0.27 to 0.41	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-23F antibodies, Y2	0.68 µg/mL Interval 0.56 to 0.82	1.24 µg/mL Interval 0.83 to 1.85	0.64 µg/mL Interval 0.48 to 0.86	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-1 antibodies, Y2	0.19 µg/mL Interval 0.17 to 0.21	0.07 µg/mL Interval 0.05 to 0.1	0.17 µg/mL Interval 0.14 to 0.2	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6B antibodies, Y2	0.7 µg/mL Interval 0.58 to 0.83	0.99 µg/mL Interval 0.57 to 1.71	0.9 µg/mL Interval 0.63 to 1.29	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-7F antibodies, Y2	0.53 µg/mL Interval 0.48 to 0.58	0.1 µg/mL Interval 0.06 to 0.16	0.59 µg/mL Interval 0.49 to 0.71	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-9V antibodies, Y2	0.64 µg/mL Interval 0.54 to 0.75	0.61 µg/mL Interval 0.37 to 1.0	0.5 µg/mL Interval 0.37 to 0.68	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-14 antibodies, Y2	1.73 µg/mL Interval 1.48 to 2.02	1.94 µg/mL Interval 1.12 to 3.36	1.7 µg/mL Interval 1.25 to 2.31	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-18C antibodies, Y2	0.54 µg/mL Interval 0.48 to 0.62	0.59 µg/mL Interval 0.39 to 0.88	0.48 µg/mL Interval 0.38 to 0.59	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19F antibodies, Y2	2.16 µg/mL Interval 1.77 to 2.65	0.99 µg/mL Interval 0.51 to 1.91	2.41 µg/mL Interval 1.67 to 3.46	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

Pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=75 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, Y4	0.2 μg/mL Interval 0.17 to 0.24	0.17 μg/mL Interval 0.07 to 0.43	0.23 μg/mL Interval 0.17 to 0.32	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, Y4	1.3 μg/mL Interval 1.1 to 1.55	1.19 μg/mL Interval 0.68 to 2.07	0.97 μg/mL Interval 0.74 to 1.27	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, Y4	0.44 μg/mL Interval 0.38 to 0.52	0.16 μg/mL Interval 0.08 to 0.36	0.49 μg/mL Interval 0.37 to 0.65	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, Y4	1.17 μg/mL Interval 0.92 to 1.47	1.19 μg/mL Interval 0.43 to 3.27	0.67 μg/mL Interval 0.46 to 0.99	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, Y4	3.66 μg/mL Interval 3.01 to 4.45	2.57 μg/mL Interval 1.22 to 5.42	2.94 μg/mL Interval 2.11 to 4.12	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, Y4	0.19 μg/mL Interval 0.16 to 0.22	0.23 μg/mL Interval 0.12 to 0.41	0.31 μg/mL Interval 0.25 to 0.38	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, Y4	0.36 μg/mL Interval 0.31 to 0.4	0.19 μg/mL Interval 0.1 to 0.35	0.35 μg/mL Interval 0.28 to 0.43	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, Y4	0.7 μg/mL Interval 0.58 to 0.84	0.87 μg/mL Interval 0.4 to 1.88	0.63 μg/mL Interval 0.45 to 0.89	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, Y4	4.17 μg/mL Interval 3.4 to 5.1	4.74 μg/mL Interval 2.24 to 10.0	4.05 μg/mL Interval 3.03 to 5.41	—
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, Y4	1.57 μg/mL Interval 1.26 to 1.96	1.64 μg/mL Interval 1.15 to 2.34	1.12 μg/mL Interval 0.79 to 1.58	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

Anti-pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F . Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=210 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=55 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, PRE	—	—	—	0.1 μg/mL Interval 0.08 to 0.12
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, D7	6.23 μg/mL Interval 5.19 to 7.49	3.24 μg/mL Interval 1.44 to 7.29	8.15 μg/mL Interval 5.71 to 11.63	1.2 μg/mL Interval 0.97 to 1.49
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, M3	—	—	—	4.55 μg/mL Interval 3.93 to 5.26
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, D7	19.38 μg/mL Interval 16.74 to 22.43	13.26 μg/mL Interval 6.91 to 25.43	18.61 μg/mL Interval 14.23 to 24.34	1.72 μg/mL Interval 1.2 to 2.46
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, D7	15.51 μg/mL Interval 13.06 to 18.43	19.71 μg/mL Interval 11.87 to 32.74	13.34 μg/mL Interval 9.34 to 19.05	2.26 μg/mL Interval 1.66 to 3.09
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, M3	—	—	—	13.21 μg/mL Interval 11.44 to 15.25
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, PRE	—	—	—	0.1 μg/mL Interval 0.07 to 0.14
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, D7	6.5 μg/mL Interval 5.61 to 7.53	9.34 μg/mL Interval 5.62 to 15.54	4.7 μg/mL Interval 3.43 to 6.45	0.42 μg/mL Interval 0.3 to 0.59
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, M3	—	—	—	1.63 μg/mL Interval 1.32 to 2.01
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, PRE	—	—	—	0.1 μg/mL Interval 0.08 to 0.13
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, D7	5.36 μg/mL Interval 4.54 to 6.33	3.04 μg/mL Interval 1.22 to 7.56	5 μg/mL Interval 3.72 to 6.71	1.35 μg/mL Interval 1.08 to 1.69
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, M3	—	—	—	2.39 μg/mL Interval 2.06 to 2.78
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, PRE	—	—	—	0.04 μg/mL Interval 0.03 to 0.05
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, D7	12.11 μg/mL Interval 10.08 to 14.54	10.45 μg/mL Interval 6.49 to 16.81	7.13 μg/mL Interval 5.18 to 9.82	4.74 μg/mL Interval 3.77 to 5.95
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, M3	—	—	—	7.32 μg/mL Interval 6.7 to 8.0
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, M3	—	—	—	3.1 μg/mL Interval 2.7 to 3.55
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, PRE	—	—	—	0.21 μg/mL Interval 0.15 to 0.29
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, D7	3.68 μg/mL Interval 3.16 to 4.29	2.85 μg/mL Interval 1.89 to 4.3	2.15 μg/mL Interval 1.62 to 2.85	0.53 μg/mL Interval 0.4 to 0.71
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, M3	—	—	—	1.25 μg/mL Interval 1.01 to 1.54
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, PRE	—	—	—	0.12 μg/mL Interval 0.09 to 0.16
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, D7	7.16 μg/mL Interval 6.11 to 8.39	3.26 μg/mL Interval 1.67 to 6.35	7.57 μg/mL Interval 5.84 to 9.81	1.67 μg/mL Interval 1.33 to 2.09
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, PRE	—	—	—	0.19 μg/mL Interval 0.12 to 0.28
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, D7	9.94 μg/mL Interval 8.59 to 11.51	9 μg/mL Interval 5.49 to 14.77	5.32 μg/mL Interval 4.08 to 6.94	0.9 μg/mL Interval 0.66 to 1.23
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, M3	—	—	—	2.2 μg/mL Interval 1.85 to 2.62
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, PRE	—	—	—	0.58 μg/mL Interval 0.38 to 0.87
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, M3	—	—	—	7.81 μg/mL Interval 6.34 to 9.63
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, PRE	—	—	—	0.1 μg/mL Interval 0.07 to 0.15
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, PRE	—	—	—	0.6 μg/mL Interval 0.4 to 0.89
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, D7	11.63 μg/mL Interval 10.0 to 13.51	16.44 μg/mL Interval 10.68 to 25.29	8.09 μg/mL Interval 6.29 to 10.42	5.12 μg/mL Interval 3.97 to 6.62
Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, M3	—	—	—	15.47 μg/mL Interval 13.08 to 18.29

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=359 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=94 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19F OPA Titers, Y1	53.4 Titer Interval 44.7 to 63.9	35.4 Titer Interval 15.9 to 78.6	58 Titer Interval 41.6 to 80.7	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-7F OPA Titers, Y1	1855.7 Titer Interval 1644.4 to 2094.1	350.4 Titer Interval 121.8 to 1008.0	1617.2 Titer Interval 1152.9 to 2268.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-9V OPA Titers, Y1	791.5 Titer Interval 701.8 to 892.8	1240.7 Titer Interval 829.4 to 1855.9	370.5 Titer Interval 281.8 to 487.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-1 OPA Titers, Y1	16.2 Titer Interval 13.8 to 19.0	4.8 Titer Interval 3.6 to 6.4	7.3 Titer Interval 5.9 to 9.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-5 OPA Titers, Y1	24.2 Titer Interval 20.8 to 28.2	5.1 Titer Interval 3.6 to 7.4	11.2 Titer Interval 8.7 to 14.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6B OPA Titers, Y1	35.5 Titer Interval 26.5 to 47.5	476.9 Titer Interval 175.3 to 1298.0	44.7 Titer Interval 24.0 to 83.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-14 OPA Titers, Y1	551.9 Titer Interval 486.5 to 626.2	607.3 Titer Interval 385.3 to 957.1	456.6 Titer Interval 361.1 to 577.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-18C OPA Titers, Y1	23.5 Titer Interval 18.6 to 29.8	15.5 Titer Interval 6.1 to 39.2	10.4 Titer Interval 7.1 to 15.4	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-4 OPA Titers, Y1	59.8 Titer Interval 45.7 to 78.3	192.9 Titer Interval 82.4 to 452.0	88.9 Titer Interval 54.6 to 144.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-23F OPA Titers, Y1	784.9 Titer Interval 625.4 to 985.0	3013.1 Titer Interval 1349.5 to 6727.2	552.3 Titer Interval 362.1 to 842.5	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=354 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=92 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-1 OPA Titers, Y2	8.4 Titer Interval 7.3 to 9.7	4 Titer Interval 4.0 to 4.0	6.3 Titer Interval 4.9 to 8.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-4 OPA Titers, Y2	29 Titer Interval 22.1 to 38.0	33.5 Titer Interval 11.9 to 94.6	39.3 Titer Interval 23.7 to 65.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-5 OPA Titers, Y2	11.4 Titer Interval 10.0 to 13.0	4.3 Titer Interval 3.9 to 4.7	7.4 Titer Interval 6.0 to 9.1	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6B OPA Titers, Y2	167.2 Titer Interval 124.1 to 225.2	526.1 Titer Interval 210.5 to 1314.4	213.7 Titer Interval 117.8 to 387.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-7F OPA Titers, Y2	1488.7 Titer Interval 1358.3 to 1631.6	1068.3 Titer Interval 619.5 to 1842.4	1387.8 Titer Interval 1096.2 to 1756.9	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-9V OPA Titers, Y2	648.5 Titer Interval 570.0 to 737.7	730.4 Titer Interval 457.7 to 1165.7	391 Titer Interval 279.2 to 547.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-14 OPA Titers, Y2	660.2 Titer Interval 567.2 to 768.4	651 Titer Interval 348.6 to 1215.5	534.4 Titer Interval 381.6 to 748.4	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-18C OPA Titers, Y2	34.9 Titer Interval 26.6 to 45.7	34.8 Titer Interval 11.7 to 103.2	17.7 Titer Interval 10.7 to 29.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19F OPA Titers, Y2	78.1 Titer Interval 60.9 to 100.2	49.2 Titer Interval 21.2 to 113.9	105.4 Titer Interval 65.8 to 168.7	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-23F OPA Titers, Y2	632 Titer Interval 483.0 to 827.0	1923 Titer Interval 952.2 to 3883.7	435 Titer Interval 250.5 to 755.5	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

Pneumococcal serotypes assessed were pneumococcal serotypes OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=253 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=16 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=72 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA Titers, Y4	37.9 Titer Interval 27.2 to 52.8	62.2 Titer Interval 13.6 to 284.7	50.7 Titer Interval 26.5 to 97.0	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA Titers, Y4	46.4 Titer Interval 33.3 to 64.5	35.3 Titer Interval 8.8 to 142.5	26.6 Titer Interval 14.3 to 49.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA Titers, Y4	1518.4 Titer Interval 1107.9 to 2080.9	3366.1 Titer Interval 1599.2 to 7085.1	1146.2 Titer Interval 596.8 to 2201.3	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA Titers, Y4	8.8 Titer Interval 7.1 to 10.9	4.6 Titer Interval 3.4 to 6.4	8.9 Titer Interval 5.9 to 13.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA Titers, Y4	7.7 Titer Interval 6.8 to 8.9	5.3 Titer Interval 3.5 to 8.1	5.5 Titer Interval 4.5 to 6.6	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA Titers, Y4	875.7 Titer Interval 658.7 to 1164.3	978.3 Titer Interval 395.3 to 2421.3	716.4 Titer Interval 417.4 to 1229.7	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA Titers, Y4	1693.1 Titer Interval 1489.3 to 1924.8	965.8 Titer Interval 666.8 to 1398.9	1602.1 Titer Interval 1286.9 to 1994.5	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA Titers, Y4	747.4 Titer Interval 624.9 to 894.1	563.8 Titer Interval 220.2 to 1444.0	558.6 Titer Interval 403.0 to 774.2	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA Titers, Y4	1139.8 Titer Interval 961.9 to 1350.5	687.9 Titer Interval 267.8 to 1767.4	849.4 Titer Interval 645.4 to 1117.8	—
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA Titers, Y4	151.7 Titer Interval 115.9 to 198.4	178.8 Titer Interval 64.6 to 495.1	129.3 Titer Interval 83.1 to 201.4	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=204 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=13 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=54 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=96 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA Titers, PRE	—	—	—	5 Titers Interval 4.2 to 5.9
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA Titers, M3	—	—	—	128.3 Titers Interval 97.3 to 169.1
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA Titers, PRE	—	—	—	11.5 Titers Interval 7.2 to 18.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA Titers, D7	3513.1 Titers Interval 2858.1 to 4318.1	3566.6 Titers Interval 2446.1 to 5200.3	1590.5 Titers Interval 942.8 to 2683.3	1971.4 Titers Interval 1238.0 to 3139.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA Titers, M3	—	—	—	4891.1 Titers Interval 4178.8 to 5724.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA Titers, D7	3378.9 Titers Interval 2652.2 to 4304.8	3478.6 Titers Interval 1788.5 to 6765.8	1663.2 Titers Interval 970.5 to 2850.2	2503.1 Titers Interval 1692.6 to 3701.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA Titers, D7	2920.8 Titers Interval 2353.5 to 3624.7	1331 Titers Interval 586.7 to 3019.5	1816.1 Titers Interval 1090.0 to 3025.8	605 Titers Interval 462.7 to 791.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA Titers, D7	23633.7 Titers Interval 19118.5 to 29215.3	10650.3 Titers Interval 3969.2 to 28577.6	8592.8 Titers Interval 5609.3 to 13163.1	18262.1 Titers Interval 15571.6 to 21417.4
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA Titers, M3	—	—	—	4451.3 Titers Interval 3962.4 to 5000.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA Titers, PRE	—	—	—	4.9 Titers Interval 4.3 to 5.7
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA Titers, D7	822.3 Titers Interval 662.7 to 1020.3	375.6 Titers Interval 217.4 to 648.9	683.6 Titers Interval 428.6 to 1090.2	295.6 Titers Interval 219.4 to 398.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA Titers, M3	—	—	—	93.2 Titers Interval 73.7 to 117.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA Titers, PRE	—	—	—	70.7 Titers Interval 33.5 to 149.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA Titers, M3	—	—	—	2536.9 Titers Interval 2014.1 to 3195.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA Titers, PRE	—	—	—	1368.2 Titers Interval 849.6 to 2185.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA Titers, D7	25196.4 Titers Interval 21149.5 to 30017.6	17828.8 Titers Interval 10270.4 to 30949.7	13098.6 Titers Interval 9715.5 to 17659.8	19243.4 Titers Interval 15701.4 to 23584.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA Titers, M3	—	—	—	9692 Titers Interval 8299.3 to 11318.4
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA Titers, PRE	—	—	—	398.2 Titers Interval 253.8 to 624.9
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA Titers, D7	9419.4 Titers Interval 7586.0 to 11695.9	12234.7 Titers Interval 8280.5 to 18077.3	7730.3 Titers Interval 5361.8 to 11145.2	8322.7 Titers Interval 6605.7 to 10486.1
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA Titers, M3	—	—	—	6456.1 Titers Interval 5458.1 to 7636.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA Titers, PRE	—	—	—	586.5 Titers Interval 439.0 to 783.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA Titers, D7	8572.3 Titers Interval 7145.4 to 10284.3	4192.8 Titers Interval 2218.6 to 7923.7	6883.1 Titers Interval 5057.3 to 9368.0	4678.2 Titers Interval 3788.0 to 5777.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA Titers, PRE	—	—	—	5.3 Titers Interval 4.2 to 6.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA Titers, M3	—	—	—	2255.9 Titers Interval 1876.9 to 2711.4
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA Titers, PRE	—	—	—	12 Titers Interval 8.3 to 17.5
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA Titers, D7	1346.4 Titers Interval 1068.6 to 1696.5	2340.4 Titers Interval 654.8 to 8365.2	662.3 Titers Interval 430.0 to 1020.1	700.2 Titers Interval 456.1 to 1074.9
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA Titers, M3	—	—	—	1437.7 Titers Interval 1146.9 to 1802.3
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA Titers, PRE	—	—	—	176.4 Titers Interval 83.4 to 373.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA Titers, D7	8700.4 Titers Interval 7021.7 to 10780.5	11341.1 Titers Interval 5374.6 to 23931.0	7871.9 Titers Interval 4965.3 to 12480.1	6813.9 Titers Interval 5249.5 to 8844.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA Titers, M3	—	—	—	5586.1 Titers Interval 4666.1 to 6687.5

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=390 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6A antibodies, Y1	0.28 μg/mL Interval 0.24 to 0.32	0.44 μg/mL Interval 0.28 to 0.7	0.27 μg/mL Interval 0.21 to 0.36	—
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19A antibodies, Y1	0.28 μg/mL Interval 0.25 to 0.32	0.21 μg/mL Interval 0.13 to 0.33	0.23 μg/mL Interval 0.17 to 0.3	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007)

Population: The analysis was performed on the ATP cohort for persistence, which included all subjects from the total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) Anti-6A antibodies, Y2	0.33 μg/mL Interval 0.28 to 0.4	0.57 μg/mL Interval 0.3 to 1.11	0.4 μg/mL Interval 0.27 to 0.58	—
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) Anti-19A antibodies, Y2	0.37 μg/mL Interval 0.31 to 0.44	0.25 μg/mL Interval 0.14 to 0.44	0.35 μg/mL Interval 0.25 to 0.5	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)

Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study, for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=75 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, Y4	0.92 μg/mL Interval 0.77 to 1.1	0.69 μg/mL Interval 0.34 to 1.38	0.75 μg/mL Interval 0.55 to 1.03	—
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, Y4	1.3 μg/mL Interval 1.07 to 1.59	1.08 μg/mL Interval 0.5 to 2.33	1.14 μg/mL Interval 0.77 to 1.68	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=210 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=55 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, PRE	—	—	—	0.2 μg/mL Interval 0.15 to 0.27
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, D7	2.2 μg/mL Interval 1.85 to 2.6	1.67 μg/mL Interval 1.0 to 2.8	1.33 μg/mL Interval 0.96 to 1.83	0.44 μg/mL Interval 0.33 to 0.58
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, M3	—	—	—	0.92 μg/mL Interval 0.73 to 1.16
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, PRE	—	—	—	0.44 μg/mL Interval 0.32 to 0.6
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, D7	2.79 μg/mL Interval 2.33 to 3.35	2.44 μg/mL Interval 1.2 to 4.96	1.72 μg/mL Interval 1.14 to 2.61	1.1 μg/mL Interval 0.84 to 1.45
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, M3	—	—	—	2.39 μg/mL Interval 1.9 to 3.01

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=352 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=26 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=93 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6A OPA Titers, Y1	59 Titers Interval 45.9 to 76.0	610.2 Titers Interval 317.7 to 1171.9	46.6 Titers Interval 28.3 to 76.8	—
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19A OPA Titers, Y1	6 Titers Interval 5.2 to 6.8	5.9 Titers Interval 3.7 to 9.5	5.5 Titers Interval 4.5 to 6.8	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=351 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=91 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6A OPA Titers, Y2	121.8 Titers Interval 95.2 to 156.0	356.5 Titers Interval 134.6 to 944.6	133.7 Titers Interval 81.8 to 218.7	—
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19A OPA Titers, Y2	12.8 Titers Interval 10.4 to 15.7	10.9 Titers Interval 5.2 to 22.8	11.1 Titers Interval 7.6 to 16.2	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=251 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=16 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=71 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA Titers, Y4	213.5 Titers Interval 165.4 to 275.7	227.8 Titers Interval 72.1 to 720.0	153.5 Titers Interval 90.5 to 260.2	—
Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA Titers, Y4	31.2 Titers Interval 23.6 to 41.3	14.3 Titers Interval 5.6 to 36.8	21.8 Titers Interval 13.3 to 35.7	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=201 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=13 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=50 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=92 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA Titers, D7	1217.7 Titers Interval 957.8 to 1548.2	1490.2 Titers Interval 681.6 to 3257.8	467.7 Titers Interval 293.8 to 744.5	826.5 Titers Interval 593.9 to 1150.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA Titers, PRE	—	—	—	9.9 Titers Interval 7.0 to 13.8
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA Titers, D7	467 Titers Interval 335.0 to 651.1	437.6 Titers Interval 81.3 to 2356.3	106.1 Titers Interval 54.1 to 208.3	431.2 Titers Interval 269.4 to 689.9
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA Titers, M3	—	—	—	376.4 Titers Interval 256.3 to 552.6
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA Titers, PRE	—	—	—	102.6 Titers Interval 61.5 to 171.2
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA Titers, M3	—	—	—	943.4 Titers Interval 691.3 to 1287.4

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

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 milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=390 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)	822.1 EL.U/mL Interval 731.5 to 923.9	93.9 EL.U/mL Interval 66.6 to 132.3	193.6 EL.U/mL Interval 155.9 to 240.4	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

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 milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=29 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)	573.2 EL.U/mL Interval 509.6 to 644.8	116.7 EL.U/mL Interval 80.9 to 168.3	157.5 EL.U/mL Interval 128.7 to 192.8	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007)

Population: The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

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 milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=75 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]	372.4 EL.U/mL Interval 329.6 to 420.9	144.9 EL.U/mL Interval 86.3 to 243.2	161.4 EL.U/mL Interval 128.4 to 203.0	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

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 milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=208 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=54 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, M3	—	—	—	708.6 EL.U/mL Interval 604.6 to 830.4
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, PRE	—	—	—	106 EL.U/mL Interval 91.1 to 123.4
Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, D7	2106 EL.U/mL Interval 1806.7 to 2454.9	718.2 EL.U/mL Interval 442.5 to 1165.7	680.7 EL.U/mL Interval 522.9 to 886.2	382.9 EL.U/mL Interval 320.7 to 457.2

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (\>) 0 millimeter (mm). Grade 3 pain = maximum intensity of local injection defined as subject crying when limb was moved/spontaneously painful. Grade 3 redness/swelling= maximum intensity of local injection \>30 mm. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=64 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects Reported With Solicited Local Symptoms Redness, Any	90 Participants	5 Participants	14 Participants	21 Participants
Number of Subjects Reported With Solicited Local Symptoms Swelling, Any	67 Participants	4 Participants	15 Participants	20 Participants
Number of Subjects Reported With Solicited Local Symptoms Redness, Grade 3 (> 30 mm)	7 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reported With Solicited Local Symptoms Pain, Any	157 Participants	9 Participants	34 Participants	54 Participants
Number of Subjects Reported With Solicited Local Symptoms Pain, Grade 3	7 Participants	1 Participants	5 Participants	3 Participants
Number of Subjects Reported With Solicited Local Symptoms Swelling, Grade 3 (> 30 mm)	5 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (any fever defined as temperature by axillary measurement of 37.5°C and above). Grade 3 drowsiness was defined as drowsiness that prevented normal activity; Grade 3 irritability was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as subject not eating at all. Grade 3 fever was defined as axillary temperature \>39.5°C. Related AE was defined as any AE assessed by investigators to be causally related to administration of the study vaccine. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=263 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=64 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects Reported With Solicited General Symptoms Irritability, Related	35 Participants	4 Participants	6 Participants	8 Participants
Number of Subjects Reported With Solicited General Symptoms Irritability, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reported With Solicited General Symptoms Loss of appetite, Grade 3	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reported With Solicited General Symptoms Fever, Any	13 Participants	0 Participants	2 Participants	5 Participants
Number of Subjects Reported With Solicited General Symptoms Fever, >39,5°C	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reported With Solicited General Symptoms Drowsiness, Any	49 Participants	2 Participants	12 Participants	12 Participants
Number of Subjects Reported With Solicited General Symptoms Drowsiness, Grade 3	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reported With Solicited General Symptoms Drowsiness, Related	48 Participants	2 Participants	11 Participants	11 Participants
Number of Subjects Reported With Solicited General Symptoms Irritability, Any	35 Participants	4 Participants	6 Participants	8 Participants
Number of Subjects Reported With Solicited General Symptoms Loss of appetite, Any	30 Participants	3 Participants	6 Participants	13 Participants
Number of Subjects Reported With Solicited General Symptoms Loss of appetite, Related	30 Participants	3 Participants	5 Participants	11 Participants
Number of Subjects Reported With Solicited General Symptoms Fever, Related	13 Participants	0 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study

Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed 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. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Follow-up period was of 31 days (Days 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 31 days for primed subjects and 2 periods of 31 days for unprimed subjects.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=65 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Unsolicited Adverse Events (AEs)	25 Participants	0 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: During Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) i.e. for each primed subject: from the time the subject was enrolled in the 111345 study until he/she completed the same study (approximatively 12 months)

Population: The analysis was performed on the primed subjects who were enrolled in the applicable 111345 Year 1 Follow-Up Study.

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" was defined an incidence of a SAE regardless of intensity/severity.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=391 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)]	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Year (Y) 2 to Y4 FU visit (post booster vaccination administered in 10PN-PD-DIT-007) i.e. for each subject(S): when S was enrolled in 111346 study until S completed the same study visit or the 111347 study visit (range of 1 to 3 years for each S))

Population: The analysis was performed on the Total enrolled cohort which included all primed subjects from Y2 follow-up sub-study 111346 and from Y4 long-term follow-up sub-study 111347 for antibody persistence for whom data concerning antibody persistence were available.

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=370 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)]	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period)

Population: The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects in study 111347. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=65 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)]	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=359 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=94 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-5 OPA, Y1	241 Participants	2 Participants	46 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6B OPA, Y1	164 Participants	23 Participants	44 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-14 OPA, Y1	336 Participants	25 Participants	89 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-18C OPA, Y1	173 Participants	10 Participants	25 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19F OPA, Y1	306 Participants	19 Participants	83 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-23F OPA, Y1	301 Participants	26 Participants	82 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-1 OPA, Y1	188 Participants	2 Participants	26 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-4 OPA, Y1	201 Participants	21 Participants	65 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-7F OPA, Y1	343 Participants	20 Participants	85 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-9V OPA, Y1	351 Participants	26 Participants	90 Participants	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=354 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=92 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-9V OPA, Y2	347 Participants	27 Participants	87 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-1 OPA, Y2	92 Participants	0 Participants	15 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-4 OPA, Y2	146 Participants	12 Participants	48 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-7F OPA Titers, Y2	350 Participants	26 Participants	90 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-18C OPA, Y2	165 Participants	11 Participants	29 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19F OPA, Y2	279 Participants	21 Participants	78 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-14 OPA, Y2	333 Participants	24 Participants	85 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-23F OPA, Y2	285 Participants	25 Participants	72 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-5 OPA, Y2	169 Participants	2 Participants	31 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6B OPA, Y2	241 Participants	24 Participants	67 Participants	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=250 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=16 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=72 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA, Y4	107 Participants	8 Participants	33 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA, Y4	248 Participants	15 Participants	71 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA, Y4	242 Participants	14 Participants	68 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA, Y4	121 Participants	8 Participants	27 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA, Y4	55 Participants	1 Participants	17 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA, Y4	80 Participants	2 Participants	11 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA, Y4	223 Participants	15 Participants	62 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA, Y4	247 Participants	14 Participants	70 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA, Y4	211 Participants	14 Participants	62 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA, Y4	209 Participants	15 Participants	55 Participants	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Analysis was performed with Unprimed group included. The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=201 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=13 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=51 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=96 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA, D7	186 Participants	13 Participants	47 Participants	87 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA, PRE	—	—	—	75 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA, D7	201 Participants	13 Participants	51 Participants	93 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA, D7	197 Participants	13 Participants	51 Participants	94 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA, M3	—	—	—	95 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA, D7	194 Participants	13 Participants	50 Participants	91 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA, D7	197 Participants	13 Participants	49 Participants	95 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA, PRE	—	—	—	8 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA, D7	193 Participants	13 Participants	48 Participants	90 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 OPA, M3	—	—	—	87 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA, PRE	—	—	—	17 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA, D7	194 Participants	13 Participants	50 Participants	93 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 OPA, M3	—	—	—	94 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA, PRE	—	—	—	8 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 OPA, M3	—	—	—	89 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA, PRE	—	—	—	35 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA, D7	196 Participants	13 Participants	48 Participants	84 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B OPA, M3	—	—	—	94 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA, PRE	—	—	—	67 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA, D7	199 Participants	13 Participants	50 Participants	93 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F OPA, M3	—	—	—	93 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V OPA, M3	—	—	—	94 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 OPA, PRE	—	—	—	81 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA, PRE	—	—	—	7 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA, D7	190 Participants	13 Participants	48 Participants	88 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C OPA, M3	—	—	—	92 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA, PRE	—	—	—	30 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F OPA, M3	—	—	—	93 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA, PRE	—	—	—	47 Participants
Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F OPA, M3	—	—	—	95 Participants

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The results for the immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=390 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=31 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6A antibodies, Y1	376 Participants	31 Participants	97 Participants	—
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19A antibodies, Y1	366 Participants	29 Participants	93 Participants	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibation ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6A antibodies, Y2	330 Participants	30 Participants	86 Participants	—
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19A antibodies, Y2	319 Participants	25 Participants	83 Participants	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=263 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=75 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, Y4	260 Participants	18 Participants	74 Participants	—
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, Y4	256 Participants	18 Participants	72 Participants	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=208 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=54 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, D7	208 Participants	14 Participants	54 Participants	92 Participants
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, PRE	—	—	—	76 Participants
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A antibodies, M3	—	—	—	97 Participants
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, PRE	—	—	—	88 Participants
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, D7	208 Participants	14 Participants	54 Participants	97 Participants
Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A antibodies, M3	—	—	—	98 Participants

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were mesured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=352 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=26 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=93 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-6A OPA, Y1	196 Participants	24 Participants	45 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] Anti-19A OPA, Y1	45 Participants	3 Participants	10 Participants	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=351 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=27 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=91 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-6A OPA, Y2	235 Participants	21 Participants	62 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] Anti-19A OPA, Y2	115 Participants	8 Participants	29 Participants	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=246 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=15 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=68 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA Titers, Y4	194 Participants	12 Participants	51 Participants	—
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA Titers, Y4	135 Participants	7 Participants	34 Participants	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=194 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=13 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=49 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=92 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA, PRE	—	—	—	57 Participants
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA, D7	185 Participants	12 Participants	46 Participants	88 Participants
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6A OPA, M3	—	—	—	87 Participants
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA, PRE	—	—	—	25 Participants
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA, D7	173 Participants	11 Participants	36 Participants	81 Participants
Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19A OPA, M3	—	—	—	87 Participants

SECONDARY outcome

Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.

A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=390 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=30 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=102 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]	373 Participants	11 Participants	71 Participants	—

SECONDARY outcome

Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.

A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=368 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=29 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=96 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)]	340 Participants	15 Participants	65 Participants	—

SECONDARY outcome

Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Population: The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.

A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=261 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=19 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=74 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]	241 Participants	12 Participants	54 Participants	—

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=208 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=54 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, D7	207 Participants	14 Participants	54 Participants	92 Participants
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, PRE	—	—	—	54 Participants
Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-PD antibodies, M3	—	—	—	98 Participants

SECONDARY outcome

Timeframe: For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.

Outcome measures

Outcome measures
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=208 Participants This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=14 Participants This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=54 Participants This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=98 Participants This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, D7	208 Participants	14 Participants	54 Participants	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, D7	207 Participants	14 Participants	54 Participants	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, PRE	—	—	—	67 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, D7	208 Participants	14 Participants	54 Participants	94 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, PRE	—	—	—	52 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, D7	207 Participants	14 Participants	54 Participants	97 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, PRE	—	—	—	69 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, D7	207 Participants	14 Participants	54 Participants	97 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-1 antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, PRE	—	—	—	29 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-4 antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, PRE	—	—	—	72 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-5 antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, PRE	—	—	—	77 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, D7	207 Participants	14 Participants	54 Participants	94 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-6B antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, PRE	—	—	—	64 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, D7	208 Participants	14 Participants	54 Participants	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-7F antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-9V antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, PRE	—	—	—	90 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, D7	208 Participants	14 Participants	54 Participants	97 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-14 antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-18C antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, PRE	—	—	—	75 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, D7	208 Participants	14 Participants	54 Participants	97 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-19F antibodies, M3	—	—	—	98 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, PRE	—	—	—	54 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, D7	208 Participants	14 Participants	54 Participants	90 Participants
Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] Anti-23F antibodies, M3	—	—	—	98 Participants

Adverse Events

Synflorix + Infanrix + Havrix and/or Varilrix Group

Serious events: 1 serious events

Other events: 188 other events

Deaths: 0 deaths

Prevenar + Infanrix + Havrix and/or Varilrix Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Unprimed Group

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 participants at risk；n=391 participants at risk This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 participants at risk；n=31 participants at risk This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=65 participants at risk；n=102 participants at risk This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 participants at risk This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
Infections and infestations Broncopneumonia	0.26% 1/391 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	0.00% 0/31 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	0.00% 0/102 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	0.00% 0/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).

Other adverse events

Other adverse events
Measure	Synflorix + Infanrix + Havrix and/or Varilrix Group n=264 participants at risk；n=391 participants at risk This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).	Prevenar + Infanrix + Havrix and/or Varilrix Group n=20 participants at risk；n=31 participants at risk This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix n=65 participants at risk；n=102 participants at risk This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).	Unprimed Group n=100 participants at risk This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.
General disorders Pain	59.5% 157/264 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	45.0% 9/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	53.1% 34/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	54.0% 54/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Redness	34.1% 90/264 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	25.0% 5/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	21.9% 14/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	21.0% 21/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Swelling	25.4% 67/264 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	20.0% 4/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	23.4% 15/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	20.0% 20/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Drowsiness	18.6% 49/263 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	10.0% 2/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	18.8% 12/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	12.0% 12/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Irritability	13.3% 35/263 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	20.0% 4/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	9.4% 6/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	8.0% 8/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Loss of appetite	11.4% 30/263 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	15.0% 3/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	9.4% 6/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	13.0% 13/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).
General disorders Fever (Axillary temperature ≥ 37.5°C)	4.9% 13/263 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	0.00% 0/20 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	3.1% 2/64 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).	5.0% 5/100 • Solicited and Unsolicited AEs were collected within 4 days and 31 days post-Synflorix vaccination, respectively, for subjects participating to Year 4 follow-up period. SAEs related to study procedure were collected at Year 1 in sub-study 111345 and from Year 2 up to Year 4 follow-up period in sub-studies 111346-111347 for primed subjects. Any SAEs were collected during the vaccination period in the111347 study (i.e. from Month 48-49 for primed subjects and from Month 0-3 for unprimed subjects).

Additional Information

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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