Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine (NCT NCT00345358)

NCT ID: NCT00345358

Last Updated: 2019-01-15

Results Overview

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The \>=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 600 participants
• Primary outcome timeframe: At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1
• Results posted on: 2019-01-15

Participant Flow

The study included a primary (PRI) phase (all groups) and a booster (BST) phase (only 10Pn <6M and Synflorix 7-11M Groups).

At screening the following was performed: informed consent was obtained from & signed by subjects' parents/guardians, check for inclusion/exclusion criteria and precautions was performed as regards contraindications to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated.

Participant milestones

Measure	Synflorix <6M Group This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Primary Vaccination Phase STARTED	150	150	150	150
Primary Vaccination Phase COMPLETED	145	146	142	148
Primary Vaccination Phase NOT COMPLETED	5	4	8	2
Booster Vaccination Phase STARTED	145	145	0	0
Booster Vaccination Phase COMPLETED	141	145	0	0
Booster Vaccination Phase NOT COMPLETED	4	0	0	0

Reasons for withdrawal

Measure	Synflorix <6M Group This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Primary Vaccination Phase Other	0	1	1	0
Primary Vaccination Phase Adverse event, non-fatal	3	1	1	0
Primary Vaccination Phase Withdrawal by Subject	1	2	4	0
Primary Vaccination Phase Lost to Follow-up	1	0	2	2
Booster Vaccination Phase Withdrawal by Subject	1	0	0	0
Booster Vaccination Phase Lost to Follow-up	3	0	0	0

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Baseline characteristics by cohort

Measure	Synflorix <6M Group n=150 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=150 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=150 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=150 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Total n=600 Participants Total of all reporting groups
Age, Continuous	10.8 Months STANDARD_DEVIATION 1.09 • n=5 Participants	8.3 Months STANDARD_DEVIATION 1.2 • n=7 Participants	17.9 Months STANDARD_DEVIATION 3.19 • n=5 Participants	36.6 Months STANDARD_DEVIATION 11.87 • n=4 Participants	18.4 Months STANDARD_DEVIATION 12.7 • n=21 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	68 Participants n=7 Participants	76 Participants n=5 Participants	72 Participants n=4 Participants	282 Participants n=21 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	82 Participants n=7 Participants	74 Participants n=5 Participants	78 Participants n=4 Participants	318 Participants n=21 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	149 Participants n=5 Participants	148 Participants n=7 Participants	149 Participants n=5 Participants	149 Participants n=4 Participants	595 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic / north African heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other pacific Islande	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other (unspecified)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.

Outcome measures

Measure	Synflorix <6M Group n=131 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=135 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=133 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=140 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-1	128 Participants	135 Participants	132 Participants	135 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-4	128 Participants	135 Participants	133 Participants	140 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-5	130 Participants	134 Participants	131 Participants	135 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-6B	95 Participants	69 Participants	108 Participants	96 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-7F	130 Participants	135 Participants	133 Participants	140 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-9V	128 Participants	129 Participants	130 Participants	132 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-14	130 Participants	132 Participants	132 Participants	127 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-18C	127 Participants	135 Participants	133 Participants	140 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-19F	122 Participants	129 Participants	131 Participants	140 Participants
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination) Anti-23F	114 Participants	95 Participants	122 Participants	93 Participants

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 µg/mL.

Outcome measures

Measure	Synflorix <6M Group n=131 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=135 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=133 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=140 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-1	1.2 μg/mL Interval 1.02 to 1.42	1.19 μg/mL Interval 1.05 to 1.35	1.22 μg/mL Interval 1.06 to 1.4	0.77 μg/mL Interval 0.66 to 0.89
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-4	1.84 μg/mL Interval 1.57 to 2.15	3.47 μg/mL Interval 3.03 to 3.97	4.21 μg/mL Interval 3.77 to 4.69	5.72 μg/mL Interval 5.0 to 6.54
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-5	2.04 μg/mL Interval 1.75 to 2.37	1.72 μg/mL Interval 1.51 to 1.96	1.8 μg/mL Interval 1.57 to 2.06	1.16 μg/mL Interval 0.99 to 1.36
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-6B	0.37 μg/mL Interval 0.29 to 0.48	0.21 μg/mL Interval 0.16 to 0.26	0.53 μg/mL Interval 0.43 to 0.65	0.38 μg/mL Interval 0.3 to 0.47
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-7F	2.03 μg/mL Interval 1.76 to 2.33	2.1 μg/mL Interval 1.83 to 2.41	3.62 μg/mL Interval 3.22 to 4.06	2.6 μg/mL Interval 2.25 to 3.01
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-9V	1.33 μg/mL Interval 1.14 to 1.55	0.91 μg/mL Interval 0.78 to 1.07	1.5 μg/mL Interval 1.3 to 1.73	1.01 μg/mL Interval 0.84 to 1.22
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-14	3 μg/mL Interval 2.61 to 3.46	2.3 μg/mL Interval 1.95 to 2.72	4.24 μg/mL Interval 3.64 to 4.95	1.36 μg/mL Interval 1.06 to 1.74
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-18C	1.84 μg/mL Interval 1.5 to 2.26	4.82 μg/mL Interval 4.14 to 5.61	9.2 μg/mL Interval 8.22 to 10.29	4.65 μg/mL Interval 4.06 to 5.31
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-19F	1.61 μg/mL Interval 1.28 to 2.02	3.36 μg/mL Interval 2.68 to 4.2	5.45 μg/mL Interval 4.63 to 6.41	5.26 μg/mL Interval 4.34 to 6.39
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Anti-23F	0.62 μg/mL Interval 0.5 to 0.76	0.4 μg/mL Interval 0.32 to 0.5	0.88 μg/mL Interval 0.73 to 1.05	0.37 μg/mL Interval 0.3 to 0.47

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 µg/mL.

Outcome measures

Measure	Synflorix <6M Group n=132 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=135 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=133 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=138 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination) Anti-6A	0.1 μg/mL Interval 0.08 to 0.12	0.06 μg/mL Interval 0.05 to 0.08	0.23 μg/mL Interval 0.18 to 0.29	0.24 μg/mL Interval 0.19 to 0.31
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination) Anti-19A	0.09 μg/mL Interval 0.07 to 0.11	0.12 μg/mL Interval 0.1 to 0.15	0.86 μg/mL Interval 0.71 to 1.05	0.65 μg/mL Interval 0.53 to 82.0

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

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

Outcome measures

Measure	Synflorix <6M Group n=44 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=48 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=51 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=41 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-14	1523.3 Titers Interval 1028.7 to 2255.6	1818.9 Titers Interval 1356.4 to 2439.2	2277.2 Titers Interval 1804.9 to 2873.0	1957.4 Titers Interval 1516.6 to 2526.3
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-1	17.3 Titers Interval 10.9 to 27.5	14.8 Titers Interval 9.3 to 23.6	14.2 Titers Interval 9.0 to 22.4	17.5 Titers Interval 9.4 to 32.3
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-4	675.6 Titers Interval 475.4 to 960.0	524 Titers Interval 361.8 to 758.9	912.1 Titers Interval 617.8 to 1346.8	2227.6 Titers Interval 1694.0 to 2929.3
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-5	52.6 Titers Interval 33.7 to 82.2	33.7 Titers Interval 21.4 to 53.3	47.5 Titers Interval 30.2 to 74.8	14.1 Titers Interval 9.1 to 22.0
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-6B	296 Titers Interval 130.3 to 672.2	25.4 Titers Interval 11.1 to 58.4	304.3 Titers Interval 143.8 to 644.2	331.7 Titers Interval 99.1 to 1109.8
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-7F	1775.1 Titers Interval 1057.8 to 2978.8	2342.5 Titers Interval 1555.2 to 3528.2	4164.2 Titers Interval 2840.4 to 6105.0	3282.2 Titers Interval 2105.1 to 5117.6
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-9V	1281.1 Titers Interval 895.0 to 1833.7	2209.6 Titers Interval 1628.6 to 2997.8	3525.8 Titers Interval 2675.4 to 4646.4	4526 Titers Interval 3581.7 to 5719.3
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-18C	181.8 Titers Interval 120.8 to 273.5	971.7 Titers Interval 723.2 to 1305.5	1765.3 Titers Interval 1330.5 to 2342.2	2051.4 Titers Interval 1558.3 to 2700.5
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-19F	194.7 Titers Interval 101.7 to 372.7	225.6 Titers Interval 128.6 to 395.7	592.7 Titers Interval 367.3 to 956.4	634.3 Titers Interval 400.2 to 1005.4
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination) Opsono-23F	925.8 Titers Interval 422.6 to 2028.3	561.1 Titers Interval 273.7 to 1150.4	1656.4 Titers Interval 1063.6 to 2579.6	1575.2 Titers Interval 802.6 to 3091.7

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

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

Outcome measures

Measure	Synflorix <6M Group n=43 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=45 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=50 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=38 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination) Opsono-6A	14.4 Titers Interval 7.5 to 27.6	39.1 Titers Interval 19.0 to 80.6	150.7 Titers Interval 80.7 to 281.3	324.6 Titers Interval 142.6 to 738.6
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination) Opsono-19	5.1 Titers Interval 3.9 to 6.6	6.1 Titers Interval 4.2 to 8.8	39.5 Titers Interval 19.0 to 81.9	31.8 Titers Interval 14.3 to 70.7

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.

Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination

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. Seropositivity = Anti-PD antibody concentrations >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix <6M Group n=131 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=135 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=133 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=139 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Antibody Concentrations Against Protein D (Anti-PD). (Primary/Full Vaccination)	1637.7 EL.U/mL Interval 1430.9 to 1874.3	654.2 EL.U/mL Interval 577.7 to 741.0	660 EL.U/mL Interval 554.9 to 785.1	224.8 EL.U/mL Interval 185.2 to 272.7

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 µg/mL.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=114 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-1, PRE	101 Subjects	102 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-1, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-4, PRE	119 Subjects	112 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-4, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-5, PRE	123 Subjects	110 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-5, POST	136 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-6B, PRE	108 Subjects	97 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-6B, POST	132 Subjects	110 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-7F, PRE	132 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-7F, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-9V, PRE	131 Subjects	108 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-9V, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-14, PRE	131 Subjects	113 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-14, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-18C, PRE	127 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-18C, POST	137 Subjects	114 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-19F, PRE	114 Subjects	112 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-19F, POST	134 Subjects	112 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-23F, PRE	116 Subjects	98 Subjects	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination) Anti-23F, POST	136 Subjects	110 Subjects	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as Anti-pneumococcal serotypes antibody concentrations >=0.05 µg/mL.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=141 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-19F, PRE	0.55 μg/mL Interval 0.44 to 0.7	1.99 μg/mL Interval 1.65 to 2.4	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-19F, POST	3.38 μg/mL Interval 2.81 to 4.06	5.71 μg/mL Interval 4.68 to 6.97	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-23F, POST	2.76 μg/mL Interval 2.37 to 3.21	1.65 μg/mL Interval 1.33 to 2.03	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-1, PRE	0.29 μg/mL Interval 0.25 to 0.34	0.49 μg/mL Interval 0.43 to 0.57	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-1, POST	1.84 μg/mL Interval 1.59 to 2.12	1.77 μg/mL Interval 1.55 to 2.02	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-4, PRE	0.56 μg/mL Interval 0.48 to 0.66	1.35 μg/mL Interval 1.17 to 1.57	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-4, POST	2.98 μg/mL Interval 2.6 to 3.42	3.79 μg/mL Interval 3.27 to 4.4	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-5, PRE	0.51 μg/mL Interval 0.44 to 0.59	0.8 μg/mL Interval 0.7 to 0.93	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-5, POST	2.21 μg/mL Interval 1.94 to 2.53	2.88 μg/mL Interval 2.48 to 3.34	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-6B, PRE	0.41 μg/mL Interval 0.34 to 0.5	0.48 μg/mL Interval 0.4 to 0.58	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-6B, POST	1.62 μg/mL Interval 1.35 to 1.94	1.39 μg/mL Interval 1.14 to 1.69	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-7F, PRE	0.82 μg/mL Interval 0.72 to 0.94	1.58 μg/mL Interval 1.39 to 1.8	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-7F, POST	3.31 μg/mL Interval 2.92 to 3.74	3.73 μg/mL Interval 3.24 to 4.28	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-9V, PRE	0.85 μg/mL Interval 0.73 to 0.98	0.79 μg/mL Interval 0.67 to 0.93	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-9V, POST	3.41 μg/mL Interval 2.96 to 3.92	2.13 μg/mL Interval 1.82 to 2.5	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-14, PRE	1.03 μg/mL Interval 0.85 to 1.25	2.3 μg/mL Interval 1.97 to 2.68	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-14, POST	3.96 μg/mL Interval 3.39 to 4.62	5.41 μg/mL Interval 4.71 to 6.22	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-18C, PRE	0.62 μg/mL Interval 0.53 to 0.74	2.58 μg/mL Interval 2.2 to 3.04	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-18C, POST	5.28 μg/mL Interval 4.55 to 6.12	9.4 μg/mL Interval 8.04 to 10.98	—	—
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination) Anti-23F, PRE	0.48 μg/mL Interval 0.39 to 0.58	0.57 μg/mL Interval 0.46 to 0.7	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 μg/mL.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=114 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination) Anti-19A, PRE	0.1 μg/mL Interval 0.09 to 0.13	0.26 μg/mL Interval 0.21 to 0.32	—	—
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination) Anti-6A, PRE	0.15 μg/mL Interval 0.12 to 0.19	0.18 μg/mL Interval 0.14 to 0.23	—	—
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination) Anti-6A, POST	0.52 μg/mL Interval 0.4 to 0.68	0.55 μg/mL Interval 0.42 to 0.73	—	—
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination) Anti-19A, POST	0.49 μg/mL Interval 0.39 to 0.61	0.99 μg/mL Interval 0.78 to 1.25	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

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

Outcome measures

Measure	Synflorix <6M Group n=51 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=40 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-1, PRE	6 Titers Interval 4.5 to 8.1	9.9 Titers Interval 5.8 to 16.9	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-1, POST	188 Titers Interval 103.6 to 342.5	234.1 Titers Interval 127.4 to 430.2	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-4, PRE	22.2 Titers Interval 12.4 to 39.9	94 Titers Interval 47.7 to 185.2	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-4, POST	1486.3 Titers Interval 1138.0 to 1941.0	978.3 Titers Interval 720.6 to 1328.1	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-5, PRE	16 Titers Interval 11.1 to 23.1	25.8 Titers Interval 16.3 to 41.0	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-5, POST	143.8 Titers Interval 93.6 to 221.0	243 Titers Interval 151.6 to 389.7	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-6B, PRE	59.3 Titers Interval 29.3 to 120.1	122.7 Titers Interval 50.3 to 299.5	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-6B, POST	262 Titers Interval 130.3 to 526.5	620.3 Titers Interval 356.5 to 1079.4	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-7F, PRE	819.6 Titers Interval 451.8 to 1423.8	1380.6 Titers Interval 730.3 to 2609.9	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-7F, POST	4199.1 Titers Interval 3364.6 to 5240.6	3726.8 Titers Interval 2759.4 to 5033.3	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-9V, PRE	328.2 Titers Interval 245.4 to 438.8	1427 Titers Interval 972.7 to 2093.4	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-9V, POST	2198 Titers Interval 1718.6 to 2811.1	2241.2 Titers Interval 1758.7 to 2856.0	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-14, PRE	158.6 Titers Interval 82.6 to 304.6	883.8 Titers Interval 597.9 to 1306.2	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-14, POST	2224.7 Titers Interval 1674.1 to 2956.5	1859.4 Titers Interval 1452.1 to 2380.9	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-18C, PRE	6.5 Titers Interval 4.2 to 10.0	395.9 Titers Interval 219.9 to 712.8	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-18C, POST	650.3 Titers Interval 437.4 to 966.8	1332.9 Titers Interval 926.3 to 1918.0	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-19F, PRE	18.7 Titers Interval 12.0 to 29.3	43.3 Titers Interval 23.3 to 80.4	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-19F, POST	418.4 Titers Interval 237.8 to 736.4	513.1 Titers Interval 265.8 to 990.2	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-23F, PRE	700.6 Titers Interval 376.5 to 1303.9	675.8 Titers Interval 293.2 to 1557.4	—	—
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination) Opsono-23F, POST	3594.5 Titers Interval 2676.8 to 4826.8	1770 Titers Interval 1148.4 to 2728.0	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

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

Outcome measures

Measure	Synflorix <6M Group n=47 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=37 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination) Opsono-6A, PRE	31.9 Titers Interval 15.9 to 63.9	140.1 Titers Interval 69.2 to 283.3	—	—
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination) Opsono-6A, POST	188.6 Titers Interval 96.9 to 367.0	302.2 Titers Interval 168.7 to 541.5	—	—
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination) Opsono-19A, PRE	5.7 Titers Interval 4.2 to 7.7	7 Titers Interval 3.9 to 12.6	—	—
Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination) Opsono-19A, POST	16.1 Titers Interval 8.6 to 30.1	36.8 Titers Interval 16.2 to 83.8	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups

Population: The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix \<6M \& 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

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. Seropositivity = Anti-PD antibody concentrations >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=114 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Antibody Concentrations Against Protein D. (Booster Vaccination) Anti-PD, PRE	750.4 EL.U/mL Interval 631.2 to 892.0	563.2 EL.U/mL Interval 475.5 to 666.9	—	—
Antibody Concentrations Against Protein D. (Booster Vaccination) Anti-PD, POST	2900.7 EL.U/mL Interval 2481.5 to 3390.8	1942 EL.U/mL Interval 1614.5 to 2335.9	—	—

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >=0.1 IU/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=132 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations. (Primary Vaccination) Anti-D, POST-PRY	0.961 IU/mL Interval 0.813 to 1.137	—	—	—
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations. (Primary Vaccination) Anti-T, POST-PRY	2.38 IU/mL Interval 2.131 to 2.659	—	—	—

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >=0.15 µg/mL and >= 1.0 µg/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=132 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Primary Vaccination)	2.886 μg/mL Interval 2.305 to 3.615	—	—	—

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary vaccination course(Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >= 5 EL.U/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=130 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination) Anti-PT, POST-PRY	51.5 EL.U/mL Interval 46.5 to 57.0	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination) Anti-FHA, POST-PRY	211.4 EL.U/mL Interval 192.7 to 231.8	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination) Anti-PRN, POST-PRY	103.2 EL.U/mL Interval 90.7 to 117.4	—	—	—

SECONDARY outcome

Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.

Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8.

Outcome measures

Measure	Synflorix <6M Group n=17 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination) Anti-Polio 1, POST-PRY	55.5 Titers Interval 30.0 to 102.6	—	—	—
Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination) Anti-Polio 2, POST-PRY	20.2 Titers Interval 9.7 to 41.9	—	—	—
Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination) Anti-Polio 3, POST-PRY	162.3 Titers Interval 73.5 to 358.5	—	—	—

SECONDARY outcome

Timeframe: Before and one month after the booster dose with Synflorix™

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix \<6M \& 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.

Booster vaccine response to PT, FHA and PRN, defined as appearance of antibodies in subjects who were seronegative (S-) prior to the booster dose (i.e., with concentrations < 5 EL.U/mL), and at least two-fold increase of pre-booster vaccination antibody concentrations in those who were seropositive (S+) prior to the booster dose (i.e., with concentrations >= 5 EL.U/ mL). Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=136 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Booster Vaccine Response to PT, FHA and PRN Anti-PT-Pre-booster status S-	14 Subjects	—	—	—
Booster Vaccine Response to PT, FHA and PRN Anti-PT-Pre-booster status S+	117 Subjects	—	—	—
Booster Vaccine Response to PT, FHA and PRN Anti-FHA-Pre-booster status S+	131 Subjects	—	—	—
Booster Vaccine Response to PT, FHA and PRN Anti-PRN-Pre-booster status S-	12 Subjects	—	—	—
Booster Vaccine Response to PT, FHA and PRN Anti-PRN-Pre-booster status S+	123 Subjects	—	—	—

SECONDARY outcome

Timeframe: Within 4-day (Days 0-3) following the primary vaccination

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).

Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the ≥24 months priming group.

Outcome measures

Measure	Synflorix <6M Group n=149 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=148 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=149 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=148 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Pain, D3	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Pain, D2	51 Participants	41 Participants	84 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Pain, Across	13 Participants	5 Participants	29 Participants	24 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Pain, D1	63 Participants	52 Participants	93 Participants	102 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Pain, D1	10 Participants	5 Participants	21 Participants	24 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Redness, D1	60 Participants	83 Participants	57 Participants	65 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Redness, D1	3 Participants	9 Participants	3 Participants	9 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Swelling, D1	37 Participants	48 Participants	39 Participants	32 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Swelling, D1	5 Participants	10 Participants	6 Participants	7 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Pain, D2	0 Participants	0 Participants	12 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Redness, D2	66 Participants	70 Participants	52 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Redness, D2	0 Participants	4 Participants	2 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Swelling, D2	38 Participants	39 Participants	38 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Swelling, D2	2 Participants	6 Participants	7 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Pain, D3	40 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Redness, D3	58 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Redness, D3	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Swelling, D3	33 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Swelling, D3	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Pain, Across	89 Participants	63 Participants	113 Participants	102 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Redness, Across	90 Participants	95 Participants	79 Participants	65 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Redness, Across	4 Participants	12 Participants	4 Participants	9 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Any Swelling, Across	68 Participants	66 Participants	59 Participants	32 Participants
Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination) Grade 3 Swelling, Across	9 Participants	14 Participants	12 Participants	7 Participants

SECONDARY outcome

Timeframe: Within 4-day (Days 0-3) following the booster vaccination

Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).

Outcome measures

Measure	Synflorix <6M Group n=144 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=145 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Any Pain	91 Participants	64 Participants	—	—
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Pain	11 Participants	3 Participants	—	—
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Any Redness	80 Participants	73 Participants	—	—
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Redness	11 Participants	5 Participants	—	—
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Any Swelling	55 Participants	45 Participants	—	—
Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Swelling	10 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: Within 4 day (Days 0-3) following the booster vacination

Population: The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix \<6M \& Synflorix 7-11M groups months groups, who received the booster dose.

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

Outcome measures

Measure	Synflorix <6M Group n=144 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=145 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Any Drowsiness	73 Participants	57 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Drowsiness	3 Participants	3 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Any Fever (Rectally)	63 Participants	33 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Fever (Rectally)	1 Participants	0 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Any Irritability	109 Participants	71 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Irritability	5 Participants	3 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Any Loss of Appet.	57 Participants	35 Participants	—	—
Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination) Grade 3 Loss of Appet.	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Within 31-day (Days 0-30) post primary vaccination

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).

An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

Outcome measures

Measure	Synflorix <6M Group n=150 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=150 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=150 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=150 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Unsolicited Adverse Events (AEs). (Primary Vaccination)	100 Participants	116 Participants	101 Participants	54 Participants

SECONDARY outcome

Timeframe: Within 31 day (Days 0-30) following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix \<6M \& Synflorix 7-11M groups months groups, who received the booster dose.

An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

Outcome measures

Measure	Synflorix <6M Group n=145 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=145 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Unsolicited Adverse Events (AEs). (Booster Vaccination)	90 Participants	63 Participants	—	—

SECONDARY outcome

Timeframe: During the Primary vaccination course up until start of Booster vaccination course

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).

A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

Outcome measures

Measure	Synflorix <6M Group n=150 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=150 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=150 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=150 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Serious Adverse Events (SAEs) (Primary Vaccination)	17 Participants	5 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: During the booster vaccination course

Population: The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix \<6M \& Synflorix 7-11M groups, who received the booster dose.

A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

Outcome measures

Measure	Synflorix <6M Group n=145 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=145 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Serious Adverse Events (SAEs). (Booster Vaccination)	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Within 4-day (Days 0-3) following the primary vaccination

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).

Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the ≥24 months priming group.

Outcome measures

Measure	Synflorix <6M Group n=149 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=148 Participants This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=149 Participants This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=148 Participants This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Irritability, Dose 1	12 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Irritability, Dose 3	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Loss of Appet., Dose 3	22 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Loss of Appet., Dose 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Loss of Appet., Across	0 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Drowsiness, Across	2 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Fever (Rectally), Across	95 Participants	55 Participants	47 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Fever (Rectally),Across	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Irritability, Across	143 Participants	112 Participants	107 Participants	62 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Irritability, Across	70 Participants	62 Participants	62 Participants	41 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Drowsiness, Dose 1	101 Participants	70 Participants	63 Participants	55 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Drowsiness, Dose 1	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Fever (Rectally), Dose 1	54 Participants	34 Participants	30 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Fever (Rectally), Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Irritability, Dose 1	122 Participants	90 Participants	90 Participants	62 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Loss of Appet, Dose 1	45 Participants	42 Participants	46 Participants	41 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Loss of Appet., Dose 1	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Drowsiness, Dose 2	64 Participants	51 Participants	48 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Drowsiness, Dose 2	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Fever (Rectally), Dose 2	60 Participants	34 Participants	24 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Fever (Rectally), Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Irritability, Dose 2	103 Participants	78 Participants	62 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Irritability, Dose 2	2 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Loss of Appet., Dose 2	31 Participants	35 Participants	31 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Loss of Appet., Dose 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Drowsiness, Dose 3	53 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Drowsiness, Dose 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Fever (Rectally), Dose 3	40 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Grade 3 Fever (Rectally), Dose 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Irritability, Dose 3	83 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Primary Vaccination) Any Drowsiness, Across	122 Participants	92 Participants	90 Participants	55 Participants

SECONDARY outcome

Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix \<6M \& 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >= 0.1 IU/mL.. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination) Anti-D, PRE-BST	0.218 IU/mL Interval 0.185 to 0.258	—	—	—
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination) Anti-T, POST-BST	10.245 IU/mL Interval 9.302 to 11.283	—	—	—
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination) Anti-D, POST-BST	4.093 IU/mL Interval 3.578 to 4.683	—	—	—
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination) Anti-T, PRE-BST	0.708 IU/mL Interval 0.616 to 0.813	—	—	—

SECONDARY outcome

Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix \<6M \& 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >= 0.15 µg/mL and >= 1.0 µg/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Booster Vaccination) Anti-PRP, PRE-BST	0.458 μg/mL Interval 0.366 to 0.573	—	—	—
Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Booster Vaccination) Anti-PRP, POST-BST	21.244 μg/mL Interval 16.778 to 26.9	—	—	—

SECONDARY outcome

Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix \<6M \& 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.

Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >=5 EL.U/mL. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-PT, PRE-BST	11.2 EL.U/mL Interval 9.8 to 12.7	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-PT, POST-BST	88.6 EL.U/mL Interval 79.5 to 98.7	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-FHA, PRE-BST	49.2 EL.U/mL Interval 43.3 to 55.9	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-FHA, POST-BST	407.1 EL.U/mL Interval 368.5 to 449.8	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-PRN, PRE-BST	17.2 EL.U/mL Interval 14.7 to 20.1	—	—	—
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination) Anti-PRN, POST-BST	276.6 EL.U/mL Interval 240.9 to 317.6	—	—	—

SECONDARY outcome

Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix \<6M \& 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix \<6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.

Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8. Since only "Synflorix <6M Group" had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome.

Outcome measures

Measure	Synflorix <6M Group n=140 Participants This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 1, PRE--BST	19.1 Titers Interval 10.4 to 34.9	—	—	—
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 1, POST-BST	617 Titers Interval 302.3 to 1259.2	—	—	—
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 2, PRE-BST	14 Titers Interval 7.6 to 25.7	—	—	—
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 2, POST-BST	498.5 Titers Interval 198.1 to 1254.3	—	—	—
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 3, PRE-BST	20.1 Titers Interval 10.6 to 38.2	—	—	—
Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination) Anti-Polio 3, POST-BST	1234.1 Titers Interval 688.3 to 2212.4	—	—	—

Adverse Events

Synflorix <6M Group

Serious events: 18 serious events

Other events: 149 other events

Deaths: 0 deaths

Synflorix 7-11M Group

Serious events: 6 serious events

Other events: 145 other events

Deaths: 0 deaths

Synflorix 12-23M Group

Serious events: 2 serious events

Other events: 144 other events

Deaths: 0 deaths

Synflorix >=24M Group

Serious events: 0 serious events

Other events: 135 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix <6M Group n=150 participants at risk This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=150 participants at risk This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=150 participants at risk This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=150 participants at risk This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic - PRI	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Psychiatric disorders Psychomotor retardation - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Gastrointestinal disorders Abdominal pain upper - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Pneumonia - PRI	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Pyelonephritis acute - PRI	2.7% 4/150 • Number of events 4 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Gastroenteritis - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Gastroenteritis rotavirus - PRI	2.0% 3/150 • Number of events 3 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Otitis media - PRI	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Exanthema subitum - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Influenza - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Respiratory syncytial virus bronchiolitis - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Respiratory syncytial virus infection - PRI	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Bacterial infection - BST	0.69% 1/145 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/145 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	— 0/0 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	— 0/0 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Gastroenteritis - BST	0.00% 0/145 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.69% 1/145 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	— 0/0 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	— 0/0 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.

Other adverse events

Measure	Synflorix <6M Group n=150 participants at risk This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 7-11M Group n=150 participants at risk This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix 12-23M Group n=150 participants at risk This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).	Synflorix >=24M Group n=150 participants at risk This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).
Eye disorders Conjunctivitis	4.7% 7/150 • Number of events 7 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	8.7% 13/150 • Number of events 13 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.7% 4/150 • Number of events 4 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Respiratory, thoracic and mediastinal disorders Cough	4.7% 7/150 • Number of events 8 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	13.3% 20/150 • Number of events 22 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	13.3% 20/150 • Number of events 24 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	3.3% 5/150 • Number of events 6 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Metabolism and nutrition disorders Decreased appetite	62.7% 94/150 • Number of events 155 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	49.3% 74/150 • Number of events 112 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	41.3% 62/150 • Number of events 77 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	27.3% 41/150 • Number of events 42 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Gastrointestinal disorders Diarrhoea	7.3% 11/150 • Number of events 12 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	10.7% 16/150 • Number of events 21 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	9.3% 14/150 • Number of events 15 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	3.3% 5/150 • Number of events 5 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Ear infection	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	10.0% 15/150 • Number of events 18 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.0% 3/150 • Number of events 3 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Skin and subcutaneous tissue disorders Erythema	72.7% 109/150 • Number of events 266 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	72.7% 109/150 • Number of events 232 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	52.7% 79/150 • Number of events 112 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	43.3% 65/150 • Number of events 66 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
General disorders Injection site haematoma	6.0% 9/150 • Number of events 9 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	3.3% 5/150 • Number of events 5 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	1.3% 2/150 • Number of events 2 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
General disorders Injection site induration	10.7% 16/150 • Number of events 22 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	8.0% 12/150 • Number of events 14 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	8.0% 12/150 • Number of events 15 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Psychiatric disorders Irritability	96.7% 145/150 • Number of events 426 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	82.7% 124/150 • Number of events 241 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	71.3% 107/150 • Number of events 152 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	42.0% 63/150 • Number of events 64 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Nasopharyngitis	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	7.3% 11/150 • Number of events 14 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Otitis media	12.7% 19/150 • Number of events 20 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	18.7% 28/150 • Number of events 34 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	13.3% 20/150 • Number of events 23 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	6.7% 10/150 • Number of events 11 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
General disorders Pain	76.0% 114/150 • Number of events 245 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	60.0% 90/150 • Number of events 157 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	75.3% 113/150 • Number of events 177 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	68.0% 102/150 • Number of events 103 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
General disorders Pyrexia	80.0% 120/150 • Number of events 238 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	58.0% 87/150 • Number of events 138 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	40.0% 60/150 • Number of events 74 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	12.7% 19/150 • Number of events 19 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Skin and subcutaneous tissue disorders Rash	5.3% 8/150 • Number of events 8 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	3.3% 5/150 • Number of events 5 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.7% 4/150 • Number of events 4 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Rhinitis	24.7% 37/150 • Number of events 52 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	22.0% 33/150 • Number of events 47 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	12.0% 18/150 • Number of events 22 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.7% 4/150 • Number of events 4 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Nervous system disorders Somnolence	86.7% 130/150 • Number of events 291 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	68.7% 103/150 • Number of events 178 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	60.0% 90/150 • Number of events 111 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	37.3% 56/150 • Number of events 57 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
General disorders Swelling	58.7% 88/150 • Number of events 163 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	51.3% 77/150 • Number of events 132 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	39.3% 59/150 • Number of events 77 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	21.3% 32/150 • Number of events 32 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Gastrointestinal disorders Teething	9.3% 14/150 • Number of events 17 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	14.7% 22/150 • Number of events 28 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.7% 4/150 • Number of events 5 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.00% 0/150 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Infections and infestations Upper respiratory tract infection	40.0% 60/150 • Number of events 80 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	28.7% 43/150 • Number of events 59 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	14.0% 21/150 • Number of events 24 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	4.7% 7/150 • Number of events 8 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.
Gastrointestinal disorders Vomiting	5.3% 8/150 • Number of events 8 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	6.0% 9/150 • Number of events 9 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	2.7% 4/150 • Number of events 4 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.	0.67% 1/150 • Number of events 1 • Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. Note that: 1) For Synflorix™ \<6M Group \& Synflorix 7-11M Group SAEs were reported during both PRI and BST Phases 2) The BST Phase safety follow-up is not applicable for the Synflorix™ 12-23M Group \& Synflorix \>=24M Group, as no booster doses were administered.

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