Trial Outcomes & Findings for Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration (NCT NCT00758264)

Last Updated: 2018-05-09

Results Overview

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

363 participants

Primary outcome timeframe

At Month 1

Results posted on

2018-05-09

Participant Flow

3 subjects have not been contacted for the Extended Safety Follow Up phase, out of which 2 subjects have not been contacted due to lost to follow-up (1 subject in Nimenrix + Synflorix Group and 1 subject in Nimenrix Group) and 1 subject due to consent withdrawal (Synflorix Group).

Participant milestones

Participant milestones
Measure	Nimenrix + Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Active Phase STARTED	182	91	90
Active Phase COMPLETED	181	91	85
Active Phase NOT COMPLETED	1	0	5
Extended Safety Follow Up (ESFU) Phase STARTED	181	90	89
Extended Safety Follow Up (ESFU) Phase COMPLETED	181	90	89
Extended Safety Follow Up (ESFU) Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix + Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Active Phase Withdrawal by Subject	0	1
Active Phase Lost to Follow-up	1	0
Active Phase Other	0	4

Baseline Characteristics

Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Total n=363 Participants Total of all reporting groups
Age, Continuous	17.2 Months STANDARD_DEVIATION 1.97 • n=99 Participants	17.2 Months STANDARD_DEVIATION 1.88 • n=107 Participants	17.4 Months STANDARD_DEVIATION 1.86 • n=206 Participants	17.25 Months STANDARD_DEVIATION 1.92 • n=7 Participants
Sex: Female, Male Female	83 Participants n=99 Participants	56 Participants n=107 Participants	47 Participants n=206 Participants	186 Participants n=7 Participants
Sex: Female, Male Male	99 Participants n=99 Participants	35 Participants n=107 Participants	43 Participants n=206 Participants	177 Participants n=7 Participants
Race/Ethnicity, Customized Hispanic	91 Participants n=99 Participants	46 Participants n=107 Participants	46 Participants n=206 Participants	183 Participants n=7 Participants
Race/Ethnicity, Customized Asian - East Asian heritage	91 Participants n=99 Participants	45 Participants n=107 Participants	44 Participants n=206 Participants	180 Participants n=7 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=175 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Anti-pneumococcal Antibody Concentrations Anti-1	3.43 μg/mL Interval 3.06 to 3.85	0.33 μg/mL Interval 0.27 to 0.41	3.60 μg/mL Interval 2.96 to 4.38
Anti-pneumococcal Antibody Concentrations Anti-4	6.86 μg/mL Interval 6.06 to 7.76	0.52 μg/mL Interval 0.41 to 0.65	6.98 μg/mL Interval 5.82 to 8.37
Anti-pneumococcal Antibody Concentrations Anti-5	4.97 μg/mL Interval 4.4 to 5.62	0.54 μg/mL Interval 0.43 to 0.67	5.07 μg/mL Interval 4.34 to 5.93
Anti-pneumococcal Antibody Concentrations Anti-6B	2.91 μg/mL Interval 2.48 to 3.41	0.53 μg/mL Interval 0.41 to 0.68	3.14 μg/mL Interval 2.55 to 3.85
Anti-pneumococcal Antibody Concentrations Anti-7F	5.32 μg/mL Interval 4.75 to 5.95	0.88 μg/mL Interval 0.74 to 1.04	5.10 μg/mL Interval 4.26 to 6.1
Anti-pneumococcal Antibody Concentrations Anti-9V	4.70 μg/mL Interval 4.15 to 5.32	0.79 μg/mL Interval 0.64 to 0.98	4.74 μg/mL Interval 3.96 to 5.67
Anti-pneumococcal Antibody Concentrations Anti-14	8.89 μg/mL Interval 7.65 to 10.33	1.16 μg/mL Interval 0.88 to 1.51	9.00 μg/mL Interval 7.4 to 10.95
Anti-pneumococcal Antibody Concentrations Anti-18C	9.81 μg/mL Interval 8.4 to 11.45	0.73 μg/mL Interval 0.56 to 0.94	19.48 μg/mL Interval 15.2 to 24.97
Anti-pneumococcal Antibody Concentrations Anti-19F	19.16 μg/mL Interval 16.6 to 22.12	1.39 μg/mL Interval 1.0 to 1.92	20.79 μg/mL Interval 17.67 to 24.45
Anti-pneumococcal Antibody Concentrations Anti-23F	4.46 μg/mL Interval 3.8 to 5.25	0.59 μg/mL Interval 0.43 to 0.81	3.79 μg/mL Interval 2.94 to 4.88

PRIMARY outcome

Timeframe: At Month 1

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=174 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=80 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=79 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value rSBA-MenA	173 Participants	78 Participants	23 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value rSBA-MenC	173 Participants	79 Participants	9 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value rSBA-MenW-135	174 Participants	79 Participants	40 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value rSBA-MenY	173 Participants	80 Participants	48 Participants

PRIMARY outcome

Timeframe: At Month 1

Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=174 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=80 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=79 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers rSBA-MenA	6673.7 Titers Interval 5680.7 to 7840.4	5016.6 Titers Interval 3594.8 to 7000.8	23.5 Titers Interval 12.7 to 43.5
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers rSBA-MenC	2496.6 Titers Interval 2096.5 to 2973.0	2044.0 Titers Interval 1522.8 to 2743.6	6.4 Titers Interval 4.7 to 8.7
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers rSBA-MenW- 135	11731.0 Titers Interval 10270.7 to 13398.9	8407.7 Titers Interval 6225.4 to 11355.0	35.8 Titers Interval 21.5 to 59.6
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers rSBA-MenY	6797.8 Titers Interval 6014.4 to 7683.4	5606.2 Titers Interval 4484.5 to 7008.3	68.4 Titers Interval 39.9 to 117.2

SECONDARY outcome

Timeframe: Before vaccination (PRE) and at one month post dose 2 (Month 2)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The 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) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=168 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=78 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Anti-pneumococcal Antibody Concentrations Anti-1, PRE	0.31 μg/mL Interval 0.26 to 0.36	0.33 μg/mL Interval 0.27 to 0.4	0.24 μg/mL Interval 0.19 to 0.3
Anti-pneumococcal Antibody Concentrations Anti-1, M2	—	4.19 μg/mL Interval 3.31 to 5.31	2.32 μg/mL Interval 1.88 to 2.87
Anti-pneumococcal Antibody Concentrations Anti-4, PRE	0.45 μg/mL Interval 0.38 to 0.53	0.57 μg/mL Interval 0.45 to 0.72	0.49 μg/mL Interval 0.39 to 0.61
Anti-pneumococcal Antibody Concentrations Anti-4, M2	—	7.80 μg/mL Interval 6.32 to 9.61	4.05 μg/mL Interval 3.3 to 4.97
Anti-pneumococcal Antibody Concentrations Anti-5, PRE	0.61 μg/mL Interval 0.53 to 0.71	0.55 μg/mL Interval 0.45 to 0.67	0.48 μg/mL Interval 0.39 to 0.59
Anti-pneumococcal Antibody Concentrations Anti-5, M2	—	4.65 μg/mL Interval 3.86 to 5.62	3.22 μg/mL Interval 2.75 to 3.78
Anti-pneumococcal Antibody Concentrations Anti-6B, PRE	0.57 μg/mL Interval 0.46 to 0.7	0.53 μg/mL Interval 0.4 to 0.69	0.48 μg/mL Interval 0.36 to 0.64
Anti-pneumococcal Antibody Concentrations Anti-6B, M2	—	2.95 μg/mL Interval 2.23 to 3.91	2.18 μg/mL Interval 1.77 to 2.69
Anti-pneumococcal Antibody Concentrations Anti-7F, PRE	0.79 μg/mL Interval 0.69 to 0.9	0.95 μg/mL Interval 0.8 to 1.14	0.71 μg/mL Interval 0.58 to 0.87
Anti-pneumococcal Antibody Concentrations Anti-7F, M2	—	6.49 μg/mL Interval 5.5 to 7.65	3.85 μg/mL Interval 3.18 to 4.66
Anti-pneumococcal Antibody Concentrations Anti-9V, PRE	0.79 μg/mL Interval 0.67 to 0.92	0.85 μg/mL Interval 0.68 to 1.06	0.75 μg/mL Interval 0.61 to 0.93
Anti-pneumococcal Antibody Concentrations Anti-9V, M2	—	5.31 μg/mL Interval 4.28 to 6.59	3.07 μg/mL Interval 2.53 to 3.73
Anti-pneumococcal Antibody Concentrations Anti-14, PRE	1.30 μg/mL Interval 1.09 to 1.56	1.37 μg/mL Interval 1.06 to 1.77	1.29 μg/mL Interval 0.97 to 1.72
Anti-pneumococcal Antibody Concentrations Anti-14, M2	—	10.60 μg/mL Interval 8.63 to 13.01	6.79 μg/mL Interval 5.51 to 8.36
Anti-pneumococcal Antibody Concentrations Anti-18C, PRE	0.79 μg/mL Interval 0.67 to 0.94	0.82 μg/mL Interval 0.61 to 1.1	0.87 μg/mL Interval 0.68 to 1.11
Anti-pneumococcal Antibody Concentrations Anti-18C, M2	—	7.78 μg/mL Interval 6.21 to 9.74	14.14 μg/mL Interval 11.08 to 18.04
Anti-pneumococcal Antibody Concentrations Anti-19F, PRE	1.36 μg/mL Interval 1.1 to 1.68	1.35 μg/mL Interval 0.97 to 1.88	1.08 μg/mL Interval 0.78 to 1.5
Anti-pneumococcal Antibody Concentrations Anti-19F, M2	—	16.90 μg/mL Interval 13.83 to 20.65	12.35 μg/mL Interval 10.23 to 14.91
Anti-pneumococcal Antibody Concentrations Anti-23F, PRE	0.62 μg/mL Interval 0.51 to 0.76	0.67 μg/mL Interval 0.48 to 0.92	0.53 μg/mL Interval 0.39 to 0.7
Anti-pneumococcal Antibody Concentrations Anti-23F, M2	—	5.25 μg/mL Interval 4.06 to 6.79	2.72 μg/mL Interval 2.15 to 3.43

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=174 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-6A, PRE	0.25 μg/mL Interval 0.2 to 0.31	0.25 μg/mL Interval 0.19 to 0.35	0.26 μg/mL Interval 0.2 to 0.35
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-6A, M1	1.54 μg/mL Interval 1.22 to 1.96	0.28 μg/mL Interval 0.2 to 0.39	2.07 μg/mL Interval 1.56 to 2.76
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-6A, M2	—	1.59 μg/mL Interval 1.1 to 2.31	1.30 μg/mL Interval 0.98 to 1.71
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-19A, PRE	0.17 μg/mL Interval 0.14 to 0.21	0.18 μg/mL Interval 0.13 to 0.25	0.16 μg/mL Interval 0.12 to 0.21
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-19A, M1	2.00 μg/mL Interval 1.58 to 2.52	0.22 μg/mL Interval 0.16 to 0.3	2.50 μg/mL Interval 1.89 to 3.3
Cross-reactive Anti-pneumococcal Antibody Concentrations Anti-19A, M2	—	2.21 μg/mL Interval 1.58 to 3.09	1.51 μg/mL Interval 1.12 to 2.04

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=68 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=28 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=27 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-23F, M1	3808.8 Titers Interval 2708.9 to 5355.4	199.0 Titers Interval 33.9 to 1168.7	3794.6 Titers Interval 2392.0 to 6019.9
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-1, PRE	6.6 Titers Interval 5.1 to 8.7	5.8 Titers Interval 4.0 to 8.4	6.2 Titers Interval 4.0 to 9.9
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-1, M1	395.3 Titers Interval 244.4 to 639.6	8.2 Titers Interval 4.4 to 15.3	438.6 Titers Interval 224.4 to 857.2
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-1, M2	—	200.8 Titers Interval 86.1 to 468.2	238.0 Titers Interval 117.5 to 482.0
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-4, PRE	13.7 Titers Interval 7.6 to 24.5	14.9 Titers Interval 6.7 to 32.9	24.9 Titers Interval 9.0 to 68.6
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-4, M1	2638.7 Titers Interval 1938.8 to 3591.1	10.3 Titers Interval 5.3 to 19.8	3621.3 Titers Interval 2488.8 to 5269.1
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-4, M2	—	2536.5 Titers Interval 1485.3 to 4331.9	1427.7 Titers Interval 683.8 to 2980.6
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-5, PRE	12.9 Titers Interval 9.6 to 17.3	10.8 Titers Interval 7.1 to 16.4	12.7 Titers Interval 7.7 to 20.9
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-5, M1	362.1 Titers Interval 261.6 to 501.2	11.0 Titers Interval 5.9 to 20.6	332.7 Titers Interval 227.2 to 487.1
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-5, M2	—	233.3 Titers Interval 132.0 to 412.2	308.9 Titers Interval 188.2 to 506.9
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-6B, PRE	37.4 Titers Interval 20.4 to 68.5	26.1 Titers Interval 11.0 to 61.9	42.7 Titers Interval 12.5 to 146.5
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-6B, M1	678.9 Titers Interval 422.1 to 1091.9	56.1 Titers Interval 16.9 to 186.8	1158.7 Titers Interval 539.3 to 2489.4
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-6B, M2	—	1112.1 Titers Interval 402.1 to 3075.8	560.6 Titers Interval 223.6 to 1405.3
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-7F, PRE	1795.6 Titers Interval 1416.5 to 2276.1	1588.3 Titers Interval 1103.6 to 2286.0	1843.1 Titers Interval 1385.7 to 2451.6
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-7F, M1	5485.4 Titers Interval 4608.2 to 6529.5	2051.2 Titers Interval 1304.0 to 3226.5	5421.5 Titers Interval 3948.8 to 7443.5
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-7F, M2	—	5235.8 Titers Interval 2619.9 to 10463.7	4444.3 Titers Interval 2918.5 to 6768.0
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-9V, PRE	728.3 Titers Interval 553.7 to 957.9	627.7 Titers Interval 427.3 to 921.9	1269.8 Titers Interval 798.4 to 2019.4
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-9V, M1	2697.7 Titers Interval 2191.1 to 3321.4	445.2 Titers Interval 218.9 to 905.5	4862.0 Titers Interval 3345.5 to 7065.9
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-9V, M2	—	2709.7 Titers Interval 1635.5 to 4489.5	3392.6 Titers Interval 2236.5 to 5146.4
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-14, PRE	329.5 Titers Interval 228.7 to 474.9	324.7 Titers Interval 161.5 to 652.9	320.5 Titers Interval 155.6 to 660.3
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-14, M1	3178.4 Titers Interval 2423.1 to 4169.1	214.3 Titers Interval 69.3 to 663.1	3914.0 Titers Interval 2506.7 to 6111.5
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-14, M2	—	2563.7 Titers Interval 1531.3 to 4292.1	2149.0 Titers Interval 1381.5 to 3342.8
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-18C, PRE	13.9 Titers Interval 8.1 to 24.0	10.5 Titers Interval 5.1 to 21.6	13.2 Titers Interval 6.6 to 26.2
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-18C, M1	1969.9 Titers Interval 1340.0 to 2895.9	8.2 Titers Interval 3.7 to 18.2	5616.8 Titers Interval 3209.6 to 9829.3
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-18C, M2	—	1229.9 Titers Interval 668.5 to 2263.0	4190.1 Titers Interval 2326.8 to 7545.6
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-19F, PRE	33.5 Titers Interval 21.2 to 52.9	34.2 Titers Interval 15.5 to 75.1	32.9 Titers Interval 14.7 to 73.4
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-19F, M1	2074.7 Titers Interval 1456.3 to 2955.6	57.3 Titers Interval 19.0 to 172.5	2534.2 Titers Interval 1794.5 to 3578.8
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-19F, M2	—	2110.4 Titers Interval 1192.5 to 3734.8	1260.4 Titers Interval 788.8 to 2013.8
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-23F, PRE	262.3 Titers Interval 128.9 to 533.7	98.1 Titers Interval 27.6 to 348.2	460.2 Titers Interval 139.7 to 1515.3
Opsonophagocytic Titers Against Pneumococcal Serotypes Opsono-23F, M2	—	3432.4 Titers Interval 2187.3 to 5386.3	3284.2 Titers Interval 2184.6 to 4937.3

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=68 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=27 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=27 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-6A, PRE	55.8 Titers Interval 30.1 to 103.5	73.1 Titers Interval 30.6 to 174.7	127.6 Titers Interval 48.9 to 333.0
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-6A, M1	355.2 Titers Interval 188.7 to 668.8	59.4 Titers Interval 17.4 to 202.7	696.6 Titers Interval 359.9 to 1348.2
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-6A, M2	—	566.0 Titers Interval 210.4 to 1522.8	284.1 Titers Interval 105.4 to 765.5
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-19A, PRE	5.3 Titers Interval 4.1 to 6.9	5.9 Titers Interval 3.6 to 9.6	7.0 Titers Interval 3.8 to 13.2
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-19A, M1	100.2 Titers Interval 50.3 to 199.5	6.3 Titers Interval 3.5 to 11.3	214.5 Titers Interval 75.3 to 611.0
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes OPSONO-19A, M2	—	203.2 Titers Interval 57.6 to 716.6	86.8 Titers Interval 28.2 to 267.2

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=43 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=40 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Anti-protein D (Anti-PD) Antibody Concentrations Anti-PD, PRE	588.4 EL.U/mL Interval 455.9 to 759.4	633.4 EL.U/mL Interval 444.0 to 903.4	514.6 EL.U/mL Interval 352.1 to 752.1
Anti-protein D (Anti-PD) Antibody Concentrations Anti-PD, M1	2340.3 EL.U/mL Interval 1882.6 to 2909.3	632.6 EL.U/mL Interval 468.1 to 854.9	2452.3 EL.U/mL Interval 1790.1 to 3359.6
Anti-protein D (Anti-PD) Antibody Concentrations Anti-PD, M2	—	2921.6 EL.U/mL Interval 2053.6 to 4156.4	1854.3 EL.U/mL Interval 1313.1 to 2618.4

SECONDARY outcome

Timeframe: Before vaccination (PRE) and at one month post dose 2 (Month 2)

Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=172 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=81 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=79 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenA, PRE	15.2 Titers Interval 10.8 to 21.4	15.3 Titers Interval 9.3 to 25.2	39.4 Titers Interval 22.1 to 70.5
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenA, M2	—	4746.8 Titers Interval 3568.4 to 6314.3	5288.0 Titers Interval 4498.0 to 6216.9
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenC, PRE	5.8 Titers Interval 4.9 to 6.9	6.1 Titers Interval 4.7 to 8.0	7.7 Titers Interval 5.6 to 10.7
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenC, M2	—	1834.6 Titers Interval 1408.1 to 2390.4	1579.9 Titers Interval 1218.9 to 2048.0
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenW, PRE	46.4 Titers Interval 33.7 to 63.7	32.7 Titers Interval 19.8 to 53.9	39.6 Titers Interval 23.9 to 65.4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenW, M2	—	5817.6 Titers Interval 4390.8 to 7708.0	7666.8 Titers Interval 6502.8 to 9039.0
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenY, PRE	66.0 Titers Interval 46.6 to 93.6	74.4 Titers Interval 44.7 to 123.9	77.0 Titers Interval 45.5 to 130.4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers rSBA-MenY, M2	—	4669.5 Titers Interval 3735.6 to 5836.8	6461.1 Titers Interval 5329.3 to 7833.2

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=78 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=43 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=40 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSY, M1	12.03 μg/mL Interval 9.63 to 15.02	10.78 μg/mL Interval 7.24 to 16.05	0.15 μg/mL Interval 0.15 to 0.16
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSY, M2	—	10.22 μg/mL Interval 7.24 to 14.41	8.47 μg/mL Interval 6.45 to 11.1
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSA, PRE	0.18 μg/mL Interval 0.16 to 0.21	0.17 μg/mL Interval 0.15 to 0.19	0.20 μg/mL Interval 0.16 to 0.25
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSA, M1	56.44 μg/mL Interval 44.38 to 71.77	41.94 μg/mL Interval 26.38 to 66.67	0.19 μg/mL Interval 0.15 to 0.23
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSA, M2	—	18.88 μg/mL Interval 12.55 to 28.41	19.80 μg/mL Interval 14.68 to 26.71
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSC, PRE	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.15 to 0.17
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSC, M1	24.11 μg/mL Interval 19.41 to 29.95	24.54 μg/mL Interval 17.77 to 33.89	0.16 μg/mL Interval 0.14 to 0.17
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSC, M2	—	11.56 μg/mL Interval 8.62 to 15.51	9.62 μg/mL Interval 7.33 to 12.63
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSW-135, PRE	0.15 μg/mL Interval 0.15 to 0.16	0.16 μg/mL Interval 0.14 to 0.19	0.15 μg/mL Interval 0.15 to 0.15
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSW-135, M1	12.11 μg/mL Interval 9.52 to 15.41	11.68 μg/mL Interval 8.06 to 16.92	0.15 μg/mL Interval 0.15 to 0.15
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSW-135, M2	—	11.38 μg/mL Interval 8.1 to 15.98	6.75 μg/mL Interval 4.94 to 9.22
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations Anti-PSY, PRE	0.15 μg/mL Interval 0.15 to 0.15	0.17 μg/mL Interval 0.14 to 0.19	0.16 μg/mL Interval 0.14 to 0.17

SECONDARY outcome

Timeframe: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=79 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=42 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=39 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Anti-tetanus (Anti-T) Antibody Concentrations Anti-T, PRE	0.499 IU/mL Interval 0.399 to 0.624	0.566 IU/mL Interval 0.428 to 0.749	0.502 IU/mL Interval 0.385 to 0.654
Anti-tetanus (Anti-T) Antibody Concentrations Anti-T, M1	18.446 IU/mL Interval 14.797 to 22.995	18.137 IU/mL Interval 12.085 to 27.218	4.412 IU/mL Interval 3.298 to 5.901
Anti-tetanus (Anti-T) Antibody Concentrations Anti-T, M2	—	16.643 IU/mL Interval 12.46 to 22.23	13.773 IU/mL Interval 10.932 to 17.352

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period after each dose

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=180 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=88 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2, Synflorix	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1, Synflorix	90 Participants	0 Participants	47 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1, Synflorix	14 Participants	0 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1, Nimenrix	87 Participants	40 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1, Nimenrix	14 Participants	4 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1, Synflorix	54 Participants	0 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1, Synflorix	2 Participants	0 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1, Nimenrix	56 Participants	31 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1, Nimenrix	3 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1, Synflorix	70 Participants	0 Participants	42 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1, Synflorix	3 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1, Nimenrix	66 Participants	37 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1, Nimenrix	3 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2, Synflorix	0 Participants	43 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2, Synflorix	0 Participants	8 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2, Nimenrix	0 Participants	0 Participants	34 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3, Dose 2, Nimenrix	0 Participants	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2, Synflorix	0 Participants	29 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2, Synflorix	0 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2, Nimenrix	0 Participants	0 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2, Nimenrix	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2, Synflorix	0 Participants	38 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2, Nimenrix	0 Participants	0 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2, Nimenrix	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-vaccination period after each dose

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=180 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=88 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	59 Participants	21 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 1	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 1	55 Participants	18 Participants	34 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	72 Participants	33 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 1	2 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 1	65 Participants	30 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	55 Participants	22 Participants	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	2 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	46 Participants	18 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	25 Participants	10 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	24 Participants	10 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	0 Participants	25 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	0 Participants	22 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	0 Participants	35 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 2	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 2	0 Participants	30 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	0 Participants	22 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	0 Participants	20 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	0 Participants	18 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	0 Participants	16 Participants	9 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Day 0-30) post-vaccination period after each dose

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With Any Unsolicited Adverse Events (AEs) Any AE(s) post-Dose 1	82 Participants	39 Participants	42 Participants
Number of Subjects With Any Unsolicited Adverse Events (AEs) Any AE(s) post-Dose 2	0 Participants	40 Participants	31 Participants

SECONDARY outcome

Timeframe: Throughout the entire study duration (Day 0-Month 7)

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With Serious Adverse Events (SAEs)	6 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Throughout the entire study duration (Day 0-Month 7)

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects Reporting Rash	9 Participants	10 Participants	5 Participants

SECONDARY outcome

Timeframe: Throughout the entire study duration (Day 0-Month 7)

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects With New Onset Chronic Illnesses (NOCIs)	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the entire study duration (Day 0-Month 7)

Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.

Outcome measures

Outcome measures
Measure	Nimenrix + Synflorix Group n=182 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 Participants Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits	13 Participants	10 Participants	9 Participants

Adverse Events

Nimenrix + Synflorix Group

Serious events: 6 serious events

Other events: 154 other events

Deaths: 0 deaths

Nimenrix Group

Serious events: 3 serious events

Other events: 81 other events

Deaths: 0 deaths

Synflorix Group

Serious events: 4 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	Nimenrix + Synflorix Group n=182 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Infections and infestations Bronchopneumonia	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	2.2% 2/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Croup infectious	1.1% 2/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Oral herpes	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	2.2% 2/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Bronchiolitis	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Nervous system disorders Febrile convulsion	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Gastroenteritis	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	1.1% 1/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Gastroenteritis bacterial	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Injury, poisoning and procedural complications Head injury	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	1.1% 1/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Gastrointestinal disorders Ileus paralytic	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Respiratory, thoracic and mediastinal disorders Infantile asthma	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Otitis media acute	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	1.1% 1/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Pharyngitis	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Respiratory tract infection	0.55% 1/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	1.1% 1/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Upper respiratory tract infection	0.00% 0/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	0.00% 0/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	1.1% 1/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).

Measure	Nimenrix + Synflorix Group n=182 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Nimenrix Group n=91 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	Synflorix Group n=90 participants at risk Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
Infections and infestations Upper respiratory tract infection (post-Dose 1)	12.1% 22/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	6.6% 6/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	10.0% 9/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Nasopharyngitis (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	15.4% 14/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	7.8% 7/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Nasopharyngitis (post-Dose 1)	13.7% 25/182 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	16.5% 15/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	20.0% 18/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Upper respiratory tract infection (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	6.6% 6/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	5.6% 5/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
Infections and infestations Upper respiratory tract infection bacterial (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	2.2% 2/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	5.6% 5/90 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Pain (post-Dose 1 of Synflorix)	50.0% 90/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	53.4% 47/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Pain (post-Dose 1 of Nimenrix)	48.3% 87/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	44.0% 40/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Redness (post-Dose 1 of Synflorix)	30.0% 54/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	36.4% 32/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Redness (post-Dose 1 of Nimenrix)	31.1% 56/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	34.1% 31/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Swelling (post-Dose 1 of Synflorix)	38.9% 70/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	47.7% 42/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Swelling (post-Dose 1 of Nimenrix)	36.7% 66/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	40.7% 37/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Pain (post-Dose 2 of Synflorix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	47.3% 43/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Pain (post-Dose 2 of Nimenrix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	40.0% 34/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Redness (post-Dose 2 of Synflorix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	31.9% 29/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Redness (post-Dose 2 of Nimenrix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	28.2% 24/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Swelling (post-Dose 2 of Synflorix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	41.8% 38/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Swelling (post-Dose 2 of Nimenrix)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	35.3% 30/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Drowsiness (post-Dose 1)	32.8% 59/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	23.1% 21/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	39.8% 35/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Irritability (post-Dose 1)	40.0% 72/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	36.3% 33/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	48.9% 43/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Loss of appetite (post-Dose 1)	30.6% 55/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	24.2% 22/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	37.5% 33/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Temperature (post-Dose 1)	13.9% 25/180 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	11.0% 10/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	17.0% 15/88 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Drowsiness (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	27.5% 25/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	20.0% 17/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Irritability(post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	38.5% 35/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	34.1% 29/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Loss of appetite (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	24.2% 22/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	25.9% 22/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).
General disorders Temperature (post-Dose 2)	— 0/0 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	19.8% 18/91 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).	12.9% 11/85 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).