Trial Outcomes & Findings for Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule (NCT NCT00307034)

NCT ID: NCT00307034

Last Updated: 2018-06-08

Results Overview

A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 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). The results presented for the Group 1 correspond to the primary outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 351 participants
• Primary outcome timeframe: One month post-dose 2 (Month 3) administration of Synflorix™ vaccine
• Results posted on: 2018-06-08

Participant Flow

Participant milestones

Measure	Synflorix I Group Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Overall Study STARTED	175	176
Overall Study COMPLETED	173	169
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Synflorix I Group Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

Baseline characteristics by cohort

Measure	Synflorix I Group n=175 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Total n=351 Participants Total of all reporting groups
Age, Continuous	12 Weeks STANDARD_DEVIATION 1.94 • n=5 Participants	12.1 Weeks STANDARD_DEVIATION 1.9 • n=7 Participants	12.05 Weeks STANDARD_DEVIATION 1.92 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	82 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	94 Participants n=7 Participants	183 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month post-dose 2 (Month 3) administration of Synflorix™ vaccine

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

A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 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). The results presented for the Group 1 correspond to the primary outcome.

Outcome measures

Measure	Synflorix I Group n=153 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=153 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-1 (N= 153, 151)	149 Subjects	149 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-4 (N=153, 153)	150 Subjects	152 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-5 (N=152, 149)	146 Subjects	149 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-6B (N=149, 149)	83 Subjects	94 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-7F (N=153, 152)	148 Subjects	151 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-9V (N=152, 153)	142 Subjects	152 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-14 (N=152, 152)	146 Subjects	152 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-18C (N=152, 153)	146 Subjects	152 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-19F (N=152, 152)	141 Subjects	146 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-23F (N=153, 152)	106 Subjects	118 Subjects

SECONDARY outcome

Timeframe: One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 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).

Outcome measures

Measure	Synflorix I Group n=156 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=149 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-7F, Month 10 (N=156, 147)	156 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-9V, Month 9 (N= 153, 149)	133 Subjects	142 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-9V, Month 10 (N=156, 147)	155 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-14, Month 9 (N= 151, 149)	140 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-14, Month 10 (N=156, 147)	155 Subjects	145 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-18C, Month 9 (N= 154, 149)	133 Subjects	144 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-18C, Month 10 (N=156, 147)	156 Subjects	146 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-19F, Month 9 (N= 153, 149)	140 Subjects	143 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-19F, Month 10 (N=156, 147)	150 Subjects	144 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-23F, Month 9 (N= 151, 148)	108 Subjects	116 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-23F, Month 10 (N=154, 147)	148 Subjects	141 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-1, Month 9 (N= 149, 147)	77 Subjects	101 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-1, Month 10 (N=156, 147)	155 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-4, Month 9 (N= 152, 149)	120 Subjects	137 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-4, Month 10 (N=155, 147)	155 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-5, Month 9 (N= 148, 149)	121 Subjects	133 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-5, Month 10 (N=155, 147)	155 Subjects	147 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-6B, Month 9 (N= 154, 148)	101 Subjects	111 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-6B, Month 10 (N=156, 147)	138 Subjects	142 Subjects
Number of Seroprotected Subjects Against Pneumococcal Serotypes Anti-7F, Month 9 (N= 151, 149)	135 Subjects	146 Subjects

SECONDARY outcome

Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=156 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=153 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Pneumococcal Serotypes Anti-1, Month 3 (N= 153, 151)	1.03 μg/mL Interval 0.9 to 1.18	1.23 μg/mL Interval 1.07 to 1.42
Antibody Concentrations Against Pneumococcal Serotypes Anti-1, Month 9 (N= 149, 147)	0.21 μg/mL Interval 0.19 to 0.24	0.3 μg/mL Interval 0.26 to 0.34
Antibody Concentrations Against Pneumococcal Serotypes Anti-1, Month 10 (N=156, 147)	1.85 μg/mL Interval 1.59 to 2.15	1.88 μg/mL Interval 1.62 to 2.17
Antibody Concentrations Against Pneumococcal Serotypes Anti-4, Month 3 (N= 153, 153)	1.37 μg/mL Interval 1.21 to 1.55	1.71 μg/mL Interval 1.47 to 1.99
Antibody Concentrations Against Pneumococcal Serotypes Anti-4, Month 9 (N= 152, 149)	0.4 μg/mL Interval 0.35 to 0.46	0.64 μg/mL Interval 0.56 to 0.73
Antibody Concentrations Against Pneumococcal Serotypes Anti-4, Month 10 (N=155, 147)	3.06 μg/mL Interval 2.68 to 3.49	3.47 μg/mL Interval 3.03 to 3.98
Antibody Concentrations Against Pneumococcal Serotypes Anti-5, Month 3 (N= 152, 149)	1.32 μg/mL Interval 1.14 to 1.52	1.85 μg/mL Interval 1.63 to 2.1
Antibody Concentrations Against Pneumococcal Serotypes Anti-5, Month 9 (N= 148, 149)	0.43 μg/mL Interval 0.37 to 0.5	0.59 μg/mL Interval 0.51 to 0.68
Antibody Concentrations Against Pneumococcal Serotypes Anti-5, Month 10 (N=155, 147)	2.65 μg/mL Interval 2.31 to 3.03	3.21 μg/mL Interval 2.81 to 3.67
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B, Month 3 (N= 149, 149)	0.19 μg/mL Interval 0.15 to 0.24	0.31 μg/mL Interval 0.25 to 0.38
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B, Month 9 (N= 154, 148)	0.28 μg/mL Interval 0.23 to 0.35	0.44 μg/mL Interval 0.36 to 0.54
Antibody Concentrations Against Pneumococcal Serotypes Anti-6B, Month 10 (N=156, 147)	1.12 μg/mL Interval 0.88 to 1.41	1.85 μg/mL Interval 1.54 to 2.22
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F, Month 3 (N= 153, 152)	1.28 μg/mL Interval 1.13 to 1.46	2.14 μg/mL Interval 1.9 to 2.4
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F, Month 9 (N= 151, 149)	0.55 μg/mL Interval 0.49 to 0.63	0.92 μg/mL Interval 0.81 to 1.05
Antibody Concentrations Against Pneumococcal Serotypes Anti-7F, Month 10 (N=156, 147)	2.81 μg/mL Interval 2.51 to 3.15	3.88 μg/mL Interval 3.45 to 4.37
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V, Month 3 (N= 152, 153)	0.92 μg/mL Interval 0.81 to 1.05	1.47 μg/mL Interval 1.29 to 1.68
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V, Month 9 (N= 153, 149)	0.52 μg/mL Interval 0.46 to 0.6	0.87 μg/mL Interval 0.77 to 0.99
Antibody Concentrations Against Pneumococcal Serotypes Anti-9V, Month 10 (N=156, 147)	2.95 μg/mL Interval 2.59 to 3.37	3.97 μg/mL Interval 3.49 to 4.5
Antibody Concentrations Against Pneumococcal Serotypes Anti-14, Month 3 (N= 152, 152)	1.72 μg/mL Interval 1.45 to 2.05	2.57 μg/mL Interval 2.22 to 2.97
Antibody Concentrations Against Pneumococcal Serotypes Anti-14, Month 9 (N= 151, 149)	0.77 μg/mL Interval 0.64 to 0.93	1.53 μg/mL Interval 1.27 to 1.85
Antibody Concentrations Against Pneumococcal Serotypes Anti-14, Month 10 (N=156, 147)	4.19 μg/mL Interval 3.62 to 4.85	5.47 μg/mL Interval 4.68 to 6.4
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C, Month 3 (N= 152, 153)	1.26 μg/mL Interval 1.06 to 1.51	3.42 μg/mL Interval 2.87 to 4.07
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C, Month 9 (N= 154, 149)	0.59 μg/mL Interval 0.5 to 0.69	1.14 μg/mL Interval 0.96 to 1.35
Antibody Concentrations Against Pneumococcal Serotypes Anti-18C, Month 10 (N=156, 147)	6.24 μg/mL Interval 5.43 to 7.18	7.2 μg/mL Interval 6.08 to 8.52
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F, Month 3 (N= 152, 152)	2.43 μg/mL Interval 1.97 to 2.98	4.43 μg/mL Interval 3.6 to 5.45
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F, Month 9 (N= 153, 149)	1.04 μg/mL Interval 0.87 to 1.25	1.7 μg/mL Interval 1.41 to 2.04
Antibody Concentrations Against Pneumococcal Serotypes Anti-19F, Month 10 (N=156, 147)	5.58 μg/mL Interval 4.65 to 6.69	6.95 μg/mL Interval 5.92 to 8.17
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F, Month 3 (N= 153, 152)	0.38 μg/mL Interval 0.3 to 0.47	0.52 μg/mL Interval 0.42 to 0.63
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F, Month 9 (N= 151, 148)	0.32 μg/mL Interval 0.26 to 0.4	0.44 μg/mL Interval 0.36 to 0.54
Antibody Concentrations Against Pneumococcal Serotypes Anti-23F, Month 10 (N=154, 147)	2.41 μg/mL Interval 1.98 to 2.94	2.78 μg/mL Interval 2.31 to 3.35

SECONDARY outcome

Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=136 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=135 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-1, Month 3 (N= 130, 132)	21.9 Titers Interval 16.4 to 29.1	26.5 Titers Interval 19.8 to 35.4
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-1, Month 9 (N= 136, 134)	5.1 Titers Interval 4.5 to 5.8	6.7 Titers Interval 5.4 to 8.3
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-1, Month 10 (N=131, 126)	109.9 Titers Interval 76.1 to 158.7	100.6 Titers Interval 68.9 to 146.9
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-4, Month 3 (N= 134, 132)	462.6 Titers Interval 410.4 to 521.4	758.9 Titers Interval 647.8 to 888.9
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-4, Month 9 (N= 104, 114)	13.8 Titers Interval 9.7 to 19.6	18.6 Titers Interval 12.7 to 27.2
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-4, Month 10 (N=125, 101)	634.6 Titers Interval 496.3 to 811.3	1204 Titers Interval 990.7 to 1463.2
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-5, Month 3 (N= 132, 130)	48.3 Titers Interval 37.7 to 61.8	68.4 Titers Interval 54.0 to 86.5
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-5, Month 9 (N= 133, 135)	9.9 Titers Interval 8.1 to 12.0	10.7 Titers Interval 8.6 to 13.4
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-5, Month 10 (N=133, 121)	102.1 Titers Interval 75.8 to 137.6	157.2 Titers Interval 123.1 to 200.7
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-6B, Month 3 (N= 125, 126)	157.8 Titers Interval 104.7 to 237.8	379.6 Titers Interval 272.4 to 529.1
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-6B, Month 9 (N= 121, 124)	56.1 Titers Interval 34.9 to 90.4	62.9 Titers Interval 40.2 to 98.5
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-6B, Month 10 (N=132, 103)	220.3 Titers Interval 146.9 to 330.3	468.5 Titers Interval 311.6 to 704.3
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-7F, Month 3 (N= 127, 131)	844.8 Titers Interval 591.4 to 1206.7	2176.5 Titers Interval 1759.2 to 2692.7
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-7F, Month 9 (N= 113, 126)	148.5 Titers Interval 89.5 to 246.4	380.6 Titers Interval 253.0 to 572.6
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-7F, Month 10 (N=128, 109)	1843.4 Titers Interval 1494.2 to 2274.1	3290.6 Titers Interval 2709.1 to 3996.8
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-9V, Month 3 (N= 134, 132)	875.1 Titers Interval 732.0 to 1046.1	1343.4 Titers Interval 1130.8 to 1596.0
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-9V, Month 9 (N= 120, 134)	266.8 Titers Interval 205.1 to 347.1	322.2 Titers Interval 256.4 to 405.1
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-9V, Month 10 (N=129, 109)	1068.1 Titers Interval 874.7 to 1304.2	1706.9 Titers Interval 1438.5 to 2025.3
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-14, Month 3 (N= 132, 131)	692.6 Titers Interval 559.1 to 858.0	1125.3 Titers Interval 946.2 to 1338.3
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-14, Month 9 (N= 102, 123)	52.1 Titers Interval 32.4 to 84.0	157.3 Titers Interval 108.5 to 228.1
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-14, Month 10 (N=107, 101)	835.5 Titers Interval 672.1 to 1038.5	1280.7 Titers Interval 1054.5 to 1555.5
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-18C, Month 3 (N= 134, 131)	56.2 Titers Interval 42.9 to 73.7	218.6 Titers Interval 176.1 to 271.4
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-18C, Month 9 (N= 122, 126)	8.3 Titers Interval 6.5 to 10.7	16.9 Titers Interval 12.5 to 22.8
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-18C, Month 10 (N=136, 130)	330 Titers Interval 259.1 to 420.3	490.8 Titers Interval 395.3 to 609.4
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-19F, Month 3 (N= 131, 128)	101 Titers Interval 74.9 to 136.0	356.7 Titers Interval 263.2 to 483.4
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-19F, Month 9 (N= 130, 134)	16.5 Titers Interval 12.9 to 21.1	31.6 Titers Interval 24.5 to 40.8
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-19F, Month 10 (N=131, 129)	251.3 Titers Interval 193.4 to 326.6	734.7 Titers Interval 568.3 to 949.8
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-23F, Month 3 (N= 131, 129)	489.7 Titers Interval 342.6 to 700.0	1233.7 Titers Interval 991.7 to 1534.7
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-23F, Month 9 (N= 112, 133)	190.7 Titers Interval 115.2 to 315.6	150.7 Titers Interval 95.9 to 236.8
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Opsono-23F, Month 10 (N=134, 121)	1047.3 Titers Interval 748.1 to 1466.3	1528.9 Titers Interval 1171.2 to 1996.0

SECONDARY outcome

Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=154 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=148 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Protein D (Anti-PD) Anti-PD, Month 3 (N=149, 148)	861.8 EL.U/mL Interval 740.4 to 1003.1	1223.3 EL.U/mL Interval 1066.5 to 1403.2
Antibody Concentrations Against Protein D (Anti-PD) Anti-PD, Month 9 (N= 151, 148)	349.7 EL.U/mL Interval 294.2 to 415.7	499.8 EL.U/mL Interval 425.3 to 587.2
Antibody Concentrations Against Protein D (Anti-PD) Anti-PD, Month 10 (N= 154, 146)	1629.8 EL.U/mL Interval 1346.4 to 1972.8	2113 EL.U/mL Interval 1808.9 to 2468.2

SECONDARY outcome

Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=156 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=151 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-D, Month 3 (N=154, 151)	1.791 IU/mL Interval 1.503 to 2.133	3.123 IU/mL Interval 2.621 to 3.723
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-D, Month 9 (N= 154, 148)	0.326 IU/mL Interval 0.275 to 0.386	0.725 IU/mL Interval 0.622 to 0.846
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-D, Month 10 (N= 156, 148)	5.423 IU/mL Interval 4.815 to 6.108	8.262 IU/mL Interval 7.339 to 9.301
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-T, Month 3 (N=154, 151)	2.504 IU/mL Interval 2.17 to 2.89	4.602 IU/mL Interval 4.062 to 5.213
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-T, Month 9 (N= 153, 149)	0.565 IU/mL Interval 0.487 to 0.656	1.191 IU/mL Interval 1.055 to 1.344
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids Anti-T, Month 10 (N= 156, 148)	7.678 IU/mL Interval 6.997 to 8.425	9.597 IU/mL Interval 8.749 to 10.526

SECONDARY outcome

Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine

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

Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=155 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=148 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP) Anti-PRP, Month 3 (N=146, 147)	1.179 μg/mL Interval 0.893 to 1.556	2.186 μg/mL Interval 1.648 to 2.9
Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP) Anti-PRP, Month 9 (N=150, 148)	0.431 μg/mL Interval 0.349 to 0.532	0.777 μg/mL Interval 0.613 to 0.984
Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP) Anti-PRP, Month 10 (N=155, 147)	16.943 μg/mL Interval 13.485 to 21.287	21.654 μg/mL Interval 17.263 to 27.161

SECONDARY outcome

Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine

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

Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.

Outcome measures

Measure	Synflorix I Group n=150 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=147 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PT, Month 3 (N=145, 144)	36.1 EL.U/mL Interval 32.9 to 39.6	33.8 EL.U/mL Interval 30.2 to 37.9
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PT, Month 9 (N=144, 145)	9.8 EL.U/mL Interval 8.7 to 11.1	10.2 EL.U/mL Interval 8.9 to 11.7
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PT, Month 10 (N=149, 145)	78.2 EL.U/mL Interval 70.5 to 86.8	65.5 EL.U/mL Interval 58.7 to 73.1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-FHA, Month 3 (N=145, 144)	166.7 EL.U/mL Interval 150.1 to 185.2	142.2 EL.U/mL Interval 125.6 to 161.1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-FHA, Month 9 (N=144, 145)	46.6 EL.U/mL Interval 41.3 to 52.6	46.9 EL.U/mL Interval 41.1 to 53.6
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-FHA, Month 10 (N=149, 144)	360.3 EL.U/mL Interval 323.7 to 401.0	276.6 EL.U/mL Interval 249.4 to 306.7
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PRN , Month 3 (N=145, 144)	83.9 EL.U/mL Interval 69.6 to 101.1	89 EL.U/mL Interval 74.1 to 106.8
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PRN, Month 9 (N=144, 145)	13.7 EL.U/mL Interval 11.2 to 16.6	18 EL.U/mL Interval 14.8 to 21.8
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Anti-PRN, Month 10 (N=150, 147)	275.5 EL.U/mL Interval 235.9 to 321.7	209.3 EL.U/mL Interval 181.8 to 241.0

SECONDARY outcome

Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.

Outcome measures

Measure	Synflorix I Group n=40 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=46 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 3 (N=37, 38)	293.7 mIU/mL Interval 195.9 to 440.5	478.6 mIU/mL Interval 294.8 to 776.9
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 9 (N=40, 46)	84.3 mIU/mL Interval 55.4 to 128.2	156.6 mIU/mL Interval 106.4 to 230.4
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 10 (N=27, 28)	1892.3 mIU/mL Interval 1012.2 to 3537.6	2922.4 mIU/mL Interval 2010.4 to 4248.1

SECONDARY outcome

Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

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

Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.

Outcome measures

Measure	Synflorix I Group n=50 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=59 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 2, Month 10 (N=17, 14)	522.4 Titers Interval 235.7 to 1157.7	512.2 Titers Interval 186.4 to 1407.7
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 3, Month 3 (N=50, 57)	165.6 Titers Interval 109.3 to 250.8	161 Titers Interval 98.7 to 262.8
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 1, Month 9 (N=45, 39)	24.6 Titers Interval 15.6 to 38.8	14.4 Titers Interval 8.9 to 23.1
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 1, Month 10 (N=20, 15)	1006.4 Titers Interval 541.8 to 1869.4	645 Titers Interval 399.4 to 1041.7
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 2, Month 3 (N=47, 59)	57.7 Titers Interval 36.8 to 90.6	40.5 Titers Interval 25.0 to 65.6
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 2, Month 9 (N=44, 40)	14.9 Titers Interval 10.7 to 20.9	10.9 Titers Interval 7.2 to 16.4
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 1, Month 3 (N=47, 57)	88.5 Titers Interval 56.3 to 139.1	99.1 Titers Interval 63.4 to 154.8
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 3, Month 9 (N=44, 38)	15.1 Titers Interval 9.8 to 23.2	14.7 Titers Interval 9.0 to 24.1
Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) Anti-Polio 3, Month 10 (N=5, 11)	1910.8 Titers Interval 257.4 to 14185.3	961.4 Titers Interval 388.3 to 2380.6

SECONDARY outcome

Timeframe: One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine

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

Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations < 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.

Outcome measures

Measure	Synflorix I Group n=137 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=142 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, Pre-booster status S+ (N=102, 121)	101 Subjects	119 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, Pre-booster status Total (N=137, 142)	136 Subjects	140 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, Pre-booster status S- (N=20, 23)	20 Subjects	23 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, Pre-booster status S+ (N=117, 117)	115 Subjects	114 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, Pre-booster status Total (N=137, 140)	135 Subjects	137 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, Pre-booster status S- (N=0, 1)	0 Subjects	1 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, Pre-booster status S+ (N=137, 138)	132 Subjects	129 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, Pre-booster status Total (N=137, 139)	132 Subjects	130 Subjects
Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, Pre-booster status S- (N=35, 21)	35 Subjects	21 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster 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 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.

Outcome measures

Measure	Synflorix I Group n=175 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, post Booster (N=174, 169)	97 Subjects	99 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, across doses (N=175; 176)	92 Subjects	110 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, across doses (N=175; 176)	14 Subjects	12 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, across doses (N=175; 176)	137 Subjects	135 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, across doses (N=175; 176)	4 Subjects	6 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, across doses (N=175; 176)	111 Subjects	105 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, across doses (N=175; 176)	20 Subjects	16 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, post Booster (N=174, 169)	103 Subjects	93 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, post Booster (N=174, 169)	7 Subjects	5 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, post Booster (N=174, 169)	118 Subjects	115 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, post Booster (N=174, 169)	20 Subjects	20 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, post Booster (N=174, 169)	19 Subjects	15 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).

Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal 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 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.

Outcome measures

Measure	Synflorix I Group n=175 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Solicited General Symptoms Any Drowsiness, across doses (N=175, 176)	130 Subjects	130 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Drowsiness, across doses (N=175, 176)	9 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms Related Drowsiness, across doses (N=175, 176)	123 Subjects	124 Subjects
Number of Subjects With Solicited General Symptoms Any Fever, across doses (N=175, 176)	108 Subjects	116 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fever, across doses (N=175, 176)	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fever, across doses (N=175, 176)	106 Subjects	108 Subjects
Number of Subjects With Solicited General Symptoms Any Irr./Fuss., across doses (N=175, 176)	149 Subjects	158 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Irr./Fuss., across doses (N=175, 176)	18 Subjects	28 Subjects
Number of Subjects With Solicited General Symptoms Related Irr./Fuss., across doses (N=175, 176)	142 Subjects	147 Subjects
Number of Subjects With Solicited General Symptoms Any Loss Appet., across doses (N=175, 176)	81 Subjects	88 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Loss Appet., across doses (N=175, 176)	5 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Loss Appet., across doses (N=175, 176)	75 Subjects	81 Subjects
Number of Subjects With Solicited General Symptoms Any Drowsiness, post Booster (N=174, 169)	97 Subjects	79 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Drowsiness, post Booster (N=174, 169)	6 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Drowsiness, post Booster (N=174, 169)	83 Subjects	71 Subjects
Number of Subjects With Solicited General Symptoms Any Fever, post Booster (N=174, 169)	96 Subjects	78 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fever, post Booster (N=174, 169)	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fever, post Booster (N=174, 169)	84 Subjects	67 Subjects
Number of Subjects With Solicited General Symptoms Any Irr./Fuss., post Booster (N=174, 169)	113 Subjects	104 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Irr./Fuss., post Booster (N=174, 169)	6 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Irr./Fuss., post Booster (N=174, 169)	99 Subjects	89 Subjects
Number of Subjects With Solicited General Symptoms Any Loss Appet., post Booster (N=174, 169)	61 Subjects	56 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Loss Appet., post Booster (N=174, 169)	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Loss Appet., post Booster (N=174, 169)	53 Subjects	43 Subjects

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) post-primary vaccination period, across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or 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 I Group n=175 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Unsolicited Adverse Events	78 Subjects	114 Subjects

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or 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 I Group n=174 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=171 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Unsolicited Adverse Events	63 Subjects	72 Subjects

SECONDARY outcome

Timeframe: During the primary vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or 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 I Group n=175 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Serious Adverse Events	5 Subjects	7 Subjects

SECONDARY outcome

Timeframe: During the booster vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or 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 I Group n=174 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=171 Participants Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Number of Subjects With Serious Adverse Events	2 Subjects	1 Subjects

Adverse Events

Synflorix I Group

Serious events: 5 serious events

Other events: 173 other events

Deaths: 0 deaths

Synflorix II Group

Serious events: 7 serious events

Other events: 175 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix I Group n=175 participants at risk Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 participants at risk Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Respiratory, thoracic and mediastinal disorders Asthma (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Nervous system disorders Febrile convulsion (Booster phase)	0.57% 1/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Gastrointestinal disorders Dyspepsia (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Skin and subcutaneous tissue disorders Dermatitis allergic (Primary phase)	0.57% 1/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Respiratory syncytial virus infection (Primary phase)	0.57% 1/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Bronchopneumonia (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Gastroenteritis (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Gastroenteritis viral (Primary phase)	0.57% 1/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Lower respiratory tract infection (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Salmonellosis (Primary phase)	0.57% 1/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Tracheitis (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Urinary tract infection (Primary phase)	0.00% 0/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.57% 1/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Viral infection (Primary phase)	0.57% 1/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Otitis media (Booster phase)	0.00% 0/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.58% 1/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Pneumonia (Booster phase)	0.57% 1/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Urinary tract infection (Booster phase)	0.57% 1/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	0.00% 0/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.

Other adverse events

Measure	Synflorix I Group n=175 participants at risk Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.	Synflorix II Group n=176 participants at risk Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
Respiratory, thoracic and mediastinal disorders Cough (Primary phase)	5.1% 9/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	5.1% 9/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Respiratory, thoracic and mediastinal disorders Cough (Booster phase)	3.4% 6/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	6.4% 11/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Pain (Primary phase)	52.6% 92/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	62.5% 110/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Redness (Primary phase)	78.3% 137/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	76.7% 135/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Swelling (Primary phase)	63.4% 111/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	59.7% 105/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Pain (Booster phase)	59.2% 103/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	55.0% 93/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Redness (Booster phase)	67.8% 118/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	68.0% 115/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Swelling (Booster phase)	55.7% 97/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	58.6% 99/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Drowsiness (Primary phase)	74.3% 130/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	73.9% 130/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Fever- rectal (Primary phase)	61.7% 108/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	65.9% 116/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Irritability (Primary phase)	85.1% 149/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	89.8% 158/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Loss of appetite (Primary phase)	46.3% 81/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	50.0% 88/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Drowsiness (Booster phase)	55.7% 97/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	46.7% 79/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Fever- rectal (Booster phase)	55.2% 96/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	46.2% 78/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Irritability (Booster phase)	64.9% 113/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	61.5% 104/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Loss of appetite (Booster phase)	35.1% 61/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	33.1% 56/169 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Pyrexia (Primary phase)	6.9% 12/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	6.8% 12/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
General disorders Pyrexia (Booster phase)	4.6% 8/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	5.8% 10/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Gastrointestinal disorders Diarrhoea	6.3% 11/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	4.5% 8/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Gastrointestinal disorders Vomiting	2.3% 4/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	5.7% 10/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Nasopharyngitis (Primary phase)	14.9% 26/175 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	26.1% 46/176 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Nasopharyngitis (Booster phase)	9.2% 16/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	11.7% 20/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.
Infections and infestations Otitis media (Booster phase)	5.2% 9/174 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.	4.1% 7/171 • Solicited symptoms: during the 4 days post-primary vaccination (across doses) and post-booster dose. Unsolicited AEs: during 31 days post-primary vaccination (across doses) and post-booster dose. SAEs: during both primary and booster vaccination periods. Analysis of AEs and SAEs was done on subjects with at least 1 primary vaccination dose. Analysis of solicited symptoms was done on subjects with at least 1 primary dose and with results available. Occurrences (all and "related to the treatment") were not calculated during the analysis and are filled in with "subjects affected" similar information.

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