Trial Outcomes & Findings for Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan. (NCT NCT02173704)

Last Updated: 2020-08-25

Results Overview

Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

225 participants

Primary outcome timeframe

At Day 1 and at one month after the third vaccination (Day 152)

Results posted on

2020-08-25

Participant Flow

Subjects were recruited from 2 sites in Taiwan

All subjects were enrolled

Participant milestones

Participant milestones
Measure	Bexsero + Routine Group Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Overall Study STARTED	150	75
Overall Study COMPLETED	137	71
Overall Study NOT COMPLETED	13	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Bexsero + Routine Group Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Other	1	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	9	4

Baseline Characteristics

Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bexsero + Routine Group n=150 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=75 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.	Total n=225 Participants Total of all reporting groups
Age, Continuous	67.9 Days STANDARD_DEVIATION 6.46 • n=5 Participants	68.9 Days STANDARD_DEVIATION 6.86 • n=7 Participants	68.3 Days STANDARD_DEVIATION 6.60 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	27 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	48 Participants n=7 Participants	116 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 1 and at one month after the third vaccination (Day 152)

Population: Analysis was done on Full Analysis Population (FAS) population day 152, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=135 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=71 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains H44/76 strain [Day 1]	0 Percentages of subjects Interval 0.0 to 3.1	0 Percentages of subjects Interval 0.0 to 6.1
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains H44/76 strain [Day 152]	100 Percentages of subjects Interval 97.2 to 100.0	0 Percentages of subjects Interval 0.0 to 5.4
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains 5/99 strain [Day 1]	1 Percentages of subjects Interval 0.02 to 4.4	1 Percentages of subjects Interval 0.04 to 7.8
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains 5/99 strain [Day 152]	100 Percentages of subjects Interval 97.2 to 100.0	0 Percentages of subjects Interval 0.0 to 5.1
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains M10713 strain [Day 1]	10 Percentages of subjects Interval 4.9 to 17.6	19 Percentages of subjects Interval 10.0 to 31.9
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains M10713 strain [Day 152]	59 Percentages of subjects Interval 50.1 to 68.1	8 Percentages of subjects Interval 2.5 to 17.0
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains NZ98/254 strain [Day 1]	0 Percentages of subjects Interval 0.0 to 2.7	0 Percentages of subjects Interval 0.0 to 5.1
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains NZ98/254 strain [Day 152]	79 Percentages of subjects Interval 71.4 to 85.8	0 Percentages of subjects Interval 0.0 to 5.1

PRIMARY outcome

Timeframe: At Day 1 and at one month after third vaccination (Day 152)

Population: Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=136 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=71 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains H44/76 strain [Day 1]	0 Percentage of subjects Interval 0.0 to 3.1	0 Percentage of subjects Interval 0.0 to 6.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains H44/76 strain [Day 152]	100 Percentage of subjects Interval 97.2 to 100.0	0 Percentage of subjects Interval 0.0 to 5.4
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains 5/99 strain [Day 1]	1 Percentage of subjects Interval 0.02 to 4.4	1 Percentage of subjects Interval 0.04 to 7.8
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains 5/99 strain [Day 152]	100 Percentage of subjects Interval 97.2 to 100.0	0 Percentage of subjects Interval 0.0 to 5.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains M10713 strain [Day 1]	11 Percentage of subjects Interval 5.6 to 18.8	25 Percentage of subjects Interval 14.1 to 37.8
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains M10713 strain [Day 152]	71 Percentage of subjects Interval 61.9 to 78.6	8 Percentage of subjects Interval 2.5 to 17.0
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains NZ98/254 strain [Day 1]	0 Percentage of subjects Interval 0.0 to 2.7	0 Percentage of subjects Interval 0.0 to 5.1
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains NZ98/254 strain [Day 152]	87 Percentage of subjects Interval 80.6 to 92.5	0 Percentage of subjects Interval 0.0 to 5.1

SECONDARY outcome

Timeframe: At Day 305 and Day 335

Population: Analysis was done on FAS population Day 335. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=136 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=71 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) H44/76 strain [Day 305]	81 Percentage of subjects Interval 73.3 to 87.8	2 Percentage of subjects Interval 0.04 to 8.4
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) H44/76 strain [Day 335]	99 Percentage of subjects Interval 95.7 to 99.98	2 Percentage of subjects Interval 0.04 to 8.4
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) 5/99 strain [Day 305]	99 Percentage of subjects Interval 94.8 to 99.82	1 Percentage of subjects Interval 0.04 to 7.7
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) 5/99 strain [Day 335]	99 Percentage of subjects Interval 94.7 to 99.82	0 Percentage of subjects Interval 0.0 to 5.1
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) M10713 strain [Day 305]	22 Percentage of subjects Interval 14.8 to 29.6	11 Percentage of subjects Interval 4.4 to 20.9
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) M10713 strain [Day 335]	92 Percentage of subjects Interval 86.3 to 96.2	13 Percentage of subjects Interval 6.1 to 23.3
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) NZ98/254 strain [Day 305]	17 Percentage of subjects Interval 11.0 to 24.3	1 Percentage of subjects Interval 0.04 to 7.7
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) NZ98/254 strain [Day 335]	94 Percentage of subjects Interval 88.7 to 97.4	0 Percentage of subjects Interval 0.0 to 5.1

SECONDARY outcome

Timeframe: At Day 1, Day 152, Day 305 and Day 335

Population: Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=145 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=73 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain [Day 1]	1.01 Titer Interval 0.99 to 1.02	1.02 Titer Interval 0.98 to 1.05
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain [Day 152]	72 Titer Interval 64.0 to 81.0	1.01 Titer Interval 0.99 to 1.03
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain [Day 305]	11 Titer Interval 9.27 to 13.0	1.26 Titer Interval 1.06 to 1.5
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain [Day 335]	157 Titer Interval 131.0 to 188.0	1.1 Titer Interval 1.01 to 1.19
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain [Day 1]	1.08 Titer Interval 0.98 to 1.18	1.03 Titer Interval 0.98 to 1.08
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain [Day 152]	963 Titer Interval 864.0 to 1073.0	1 Titer Interval 1.0 to 1.0
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain [Day 305]	205 Titer Interval 174.0 to 242.0	1.1 Titer Interval 0.91 to 1.33
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain [Day 335]	2315 Titer Interval 1893.0 to 2832.0	1 Titer Interval 1.0 to 1.0
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain [Day 1]	1.36 Titer Interval 1.2 to 1.54	1.75 Titer Interval 1.37 to 2.24
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain [Day 152]	8.41 Titer Interval 6.63 to 11.0	1.25 Titer Interval 1.08 to 1.46
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain [Day 305]	2.18 Titer Interval 1.81 to 2.63	1.6 Titer Interval 1.34 to 1.91
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain [Day 335]	17 Titer Interval 14.0 to 20.0	1.58 Titer Interval 1.33 to 1.89
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain [Day 1]	1.01 Titer Interval 0.99 to 1.02	1 Titer Interval 1.0 to 1.0
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain [Day 152]	9.2 Titer Interval 7.82 to 11.0	1.02 Titer Interval 0.98 to 1.05
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain [Day 305]	1.91 Titer Interval 1.63 to 2.25	1.04 Titer Interval 0.98 to 1.1
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain [Day 335]	26 Titer Interval 21.0 to 31.0	1 Titer Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: At Day 1, Day 152, Day 305 and Day 335

GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=135 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=71 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. H44/76 strain [Day 152/Day 1]	71 Ratio Interval 63.0 to 80.0	0.99 Ratio Interval 0.95 to 1.04
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. H44/76 strain [Day 335/Day 305]	155 Ratio Interval 127.0 to 188.0	1.07 Ratio Interval 0.97 to 1.19
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. 5/99 strain [Day 152/Day 1]	875 Ratio Interval 752.0 to 1019.0	0.97 Ratio Interval 0.93 to 1.03
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. 5/99 strain [Day 335/Day 305]	2110 Ratio Interval 1674.0 to 2659.0	0.97 Ratio Interval 0.93 to 1.03
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. M10713 strain [Day 152/Day 1]	5.69 Ratio Interval 4.25 to 7.61	0.68 Ratio Interval 0.54 to 0.85
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. M10713 strain [Day 335/Day 305]	12 Ratio Interval 8.99 to 15.0	0.91 Ratio Interval 0.68 to 1.21
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. NZ98/254 strain [Day 152/Day 1]	9.18 Ratio Interval 7.79 to 11.0	1.02 Ratio Interval 0.98 to 1.05
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. NZ98/254 strain [Day 335/Day 305]	25 Ratio Interval 21.0 to 31.0	1 Ratio Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: At Day 1,Day 152,Day 305, Day 335

Population: Analysis was done on FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines \[Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®\] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines \[Priorix® and Varilrix® vaccine\],as compared to when only routine vaccines were administered.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=145 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=73 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain (Day 1)	0 Percentages of subjects Interval 0.0 to 2.8	0 Percentages of subjects Interval 0.0 to 5.5
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain (Day 152)	100 Percentages of subjects Interval 97.2 to 100.0	0 Percentages of subjects Interval 0.0 to 5.4
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain (Day 305)	66 Percentages of subjects Interval 56.8 to 74.2	2 Percentages of subjects Interval 0.04 to 8.4
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines H44/76 strain (Day 335)	99 Percentages of subjects Interval 95.7 to 99.98	0 Percentages of subjects Interval 0.0 to 5.6
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain (Day 1)	1 Percentages of subjects Interval 0.02 to 3.9	0 Percentages of subjects Interval 0.0 to 5.0
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain (Day 152)	100 Percentages of subjects Interval 97.2 to 100.0	0 Percentages of subjects Interval 0.0 to 5.1
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain (Day 305)	99 Percentages of subjects Interval 94.8 to 99.82	1 Percentages of subjects Interval 0.04 to 7.7
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines 5/99 strain (Day 335)	99 Percentages of subjects Interval 94.7 to 99.82	0 Percentages of subjects Interval 0.0 to 5.1
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain (Day 1)	3 Percentages of subjects Interval 0.9 to 8.2	8 Percentages of subjects Interval 2.6 to 17.3
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain (Day 152)	49 Percentages of subjects Interval 39.7 to 58.0	5 Percentages of subjects Interval 1.0 to 12.9
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain (Day 305)	15 Percentages of subjects Interval 9.7 to 22.8	3 Percentages of subjects Interval 0.37 to 10.7
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines M10713 strain (Day 335)	77 Percentages of subjects Interval 68.7 to 83.9	6 Percentages of subjects Interval 1.6 to 14.2
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain (Day 1)	0 Percentages of subjects Interval 0.0 to 2.5	0 Percentages of subjects Interval 0.0 to 4.9
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain (Day 152)	59 Percentages of subjects Interval 49.7 to 66.9	0 Percentages of subjects Interval 0.0 to 5.1
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain (Day 305)	9 Percentages of subjects Interval 4.6 to 14.9	0 Percentages of subjects Interval 0.0 to 5.1
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines NZ98/254 strain (Day 335)	86 Percentages of subjects Interval 79.0 to 91.4	0 Percentages of subjects Interval 0.0 to 5.1

SECONDARY outcome

Timeframe: From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)

Population: Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.

Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=148 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=73 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (3rd Prevenar-13®)	27 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (1st Bexsero®)	54 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (1st Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (1st Bexsero®)	34 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (1st Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (1st Bexsero®)	63 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (1st Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (1st Bexsero®)	75 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (1st Bexsero®)	8 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (1st Infanrix-IPV + Hib®)	26 Number of participants	3 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema(1st Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (1st Infanrix-IPV + Hib®)	15 Number of participants	3 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling(1st Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (1st Infanrix-IPV + Hib®)	45 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Tenderness(1st Infanrix-IPV+Hib®)	2 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration(1st Infanrix-IPV + Hib®)	23 Number of participants	11 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Induration(1st Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (1st Prevenar-13®)	26 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (1st Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (1st Prevenar-13®)	29 Number of participants	15 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (1st Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (1st Prevenar-13®)	11 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (1st Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (1st Prevenar-13®)	50 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (1st Prevenar-13®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (2nd Bexsero®)	59 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (2nd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (2nd Bexsero®)	35 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (2nd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (2nd Bexsero®)	51 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (2nd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (2nd Bexsero®)	67 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (2nd Bexsero®)	5 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (2nd Infanrix-IPV + Hib®)	39 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema(2nd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (2nd Infanrix-IPV + Hib®)	18 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling(2nd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (2nd Infanrix-IPV + Hib®)	23 Number of participants	16 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Induration(2nd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (2nd Infanrix-IPV + Hib®)	45 Number of participants	10 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Tenderness(2nd Infanrix-IPV+Hib®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (2nd Prevenar-13®)	35 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (2nd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (2nd Prevenar-13®)	18 Number of participants	8 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (2nd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (2nd Prevenar-13®)	12 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (2nd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (2nd Prevenar-13®)	44 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (2nd Prevenar-13®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (3rd Engerix-B®)	33 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (3rd Engerix-B®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (3rd Engerix-B®)	33 Number of participants	17 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (3rd Engerix-B®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (3rd Engerix-B®)	25 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (3rd Engerix-B®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (3rd Engerix-B®)	45 Number of participants	7 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (3rd Engerix-B®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (3rd Bexsero®)	55 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (3rd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (3rd Bexsero®)	57 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (3rd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (3rd Bexsero®)	49 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (3rd Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (3rd Bexsero®)	68 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (3rd Bexsero®)	6 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (3rd Infanrix-IPV+Hib®)	20 Number of participants	10 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (3rd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (3rd Infanrix-IPV+Hib®)	28 Number of participants	15 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (3rd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration(3rd Infanrix-IPV+Hib®)	25 Number of participants	16 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Induration(3rd Infanrix-IPV+Hib®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (3rd Infanrix-IPV+ Hib®)	42 Number of participants	8 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3Tenderness(3rd Infanrix-IPV+Hib®)	2 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (3rd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (3rd Prevenar-13®)	21 Number of participants	11 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (3rd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (3rd Prevenar-13®)	17 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (3rd Prevenar-13®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (3rd Prevenar-13®)	45 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (3rd Prevenar-13®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (4th Bexsero®)	53 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (4th Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (4th Bexsero®)	44 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (4th Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (4th Bexsero®)	56 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration(4th Bexsero®)	0 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (4th Bexsero®)	66 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (4th Bexsero®)	6 Number of participants	—
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (4th Priorix®)	24 Number of participants	13 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (4th Priorix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (4th Priorix®)	15 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (4th Priorix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (4th Priorix®)	19 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (4th Priorix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (4th Priorix®)	37 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (4th Priorix®)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Erythema (4th Varilrix®)	32 Number of participants	14 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Erythema (4th Varilrix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Induration (4th Varilrix®)	14 Number of participants	7 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Induration (4th Varilrix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Swelling (4th Varilrix®)	21 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Swelling (4th Varilrix®)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Tenderness (4th Varilrix®)	41 Number of participants	5 Number of participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Tenderness (4th Varilrix®)	3 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: From day 1 (6 hours) to day 7 after each vaccination

Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=148 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=73 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Change in Eating Habits (1st vacc)	92 Number of participants	26 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade3 Change in Eating Habits(1st vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Change in Eating Habits (2nd vacc)	72 Number of participants	21 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade3 Change in Eating Habits(2nd vacc)	2 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Change in Eating Habits (3rd vacc)	72 Number of participants	17 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade3 Change in Eating Habits(3rd vacc)	1 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Diarrhea (1st vacc)	28 Number of participants	8 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Diarrhea (1st vacc)	2 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Diarrhea (2nd vacc)	30 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Diarrhea (2nd vacc)	1 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Diarrhea (3rd vacc)	19 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Diarrhea (3rd vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Irritability (1st vacc)	111 Number of participants	32 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Irritability (1st vacc)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Irritability (2nd vacc)	90 Number of participants	31 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Irritability (2nd vacc)	5 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Irritability (3rd vacc)	94 Number of participants	28 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Irritability (3rd vacc)	3 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Persistent Crying (1st vacc)	96 Number of participants	30 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Persistent Crying (1st vacc)	5 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Persistent Crying (2nd vacc)	82 Number of participants	23 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Persistent Crying (2nd vacc)	5 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Persistent Crying (3rd vacc)	72 Number of participants	28 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Persistent Crying (3rd vacc)	3 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Rash (1st vacc)	18 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Rash (1st vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Rash (2nd vacc)	18 Number of participants	8 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Rash (2nd vacc)	0 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Rash (3rd vacc)	16 Number of participants	4 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Rash (3rd vacc)	1 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Sleepiness (1st vacc)	79 Number of participants	33 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Sleepiness (1st vacc)	0 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Sleepiness (2nd vacc)	66 Number of participants	21 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Sleepiness (2nd vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Sleepiness (3rd vacc)	49 Number of participants	13 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Sleepiness (3rd vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Vomiting (1st vacc)	21 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Vomiting (1st vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Vomiting (2nd vacc)	16 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Vomiting (2nd vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Vomiting (3rd vacc)	15 Number of participants	7 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Vomiting (3rd vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Fever (1st vacc)	71 Number of participants	11 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Fever (2nd vacc)	72 Number of participants	11 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Fever (3rd vacc)	68 Number of participants	12 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Change in Eating Habits (4th vacc)	58 Number of participants	19 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade3 Change in Eating Habits(4th vacc)	2 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Diarrhea (4th vacc)	27 Number of participants	10 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Diarrhea (4th vacc)	1 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Irritability (4th vacc)	71 Number of participants	16 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Irritability (4th vacc)	2 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Persistent Crying (4th vacc)	58 Number of participants	15 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Persistent Crying (4th vacc)	0 Number of participants	1 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Rash (4th vacc)	25 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Rash (4th vacc)	1 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Sleepiness (4th vacc)	36 Number of participants	9 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Sleepiness (4th vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Any Vomiting (4th vacc)	10 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Grade 3 Vomiting (4th vacc)	0 Number of participants	0 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Fever (4th vacc)	60 Number of participants	6 Number of participants
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. Lymphadenopathy (4th vacc)	1 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28 after vaccination

Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=137 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=72 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. Any Rash (4th vacc)	50 Number of participants	24 Number of participants
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. Grade 3 rash (4th vacc)	5 Number of participants	5 Number of participants
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. Lymphadenopathy (4th vacc)	34 Number of participants	21 Number of participants
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. Fever (temperature ≥ 38.0°C)	91 Number of participants	33 Number of participants
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. Grade 3 fever (temperature ≥ 40.0°C)	2 Number of participants	5 Number of participants

SECONDARY outcome

Timeframe: From day 1 to day 7 after each vaccination

Population: Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.

Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=145 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=72 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines Any AEs (1st vacc)	46 Number of subjects	8 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines At least possible related AEs (1st vacc)	35 Number of subjects	6 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines Any AEs (2nd vacc)	30 Number of subjects	7 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines At least possible related AEs (2nd vacc)	22 Number of subjects	5 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines Any AEs (3rd vacc)	51 Number of subjects	18 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines At least possible related AEs (3rd vacc)	45 Number of subjects	7 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines Any AEs (booster)	43 Number of subjects	9 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines At least possible related AEs (booster)	37 Number of subjects	4 Number of subjects

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Day 335)

Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.

Outcome measures

Outcome measures
Measure	Bexsero + Routine Group n=145 Participants Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	Routine Group n=72 Participants Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. Any SAEs	13 Number of participants	8 Number of participants
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. At least possible related SAEs	0 Number of participants	0 Number of participants
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. AEs resulting in premature withdrawal	4 Number of participants	0 Number of participants
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. AEs leading to hospitalization	13 Number of participants	8 Number of participants
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. Medically attended AEs	131 Number of participants	66 Number of participants
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. AEs leading to death	0 Number of participants	0 Number of participants

Adverse Events

Bexsero + Routine Group

Serious events: 13 serious events

Other events: 148 other events

Deaths: 0 deaths

Routine Group

Serious events: 8 serious events

Other events: 72 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