Trial Outcomes & Findings for Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants (NCT NCT02106390)

Last Updated: 2018-08-22

Results Overview

Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

750 participants

Primary outcome timeframe

At Day 331 (one month after the fourth vaccination)

Results posted on

2018-08-22

Participant Flow

750 healthy infants, aged 3 months were recruited from 3 sites in Argentina and 4 sites in Mexico.

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	rMenB+ACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.	rMenB Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Overall Study STARTED	252	250	248
Overall Study COMPLETED	203	202	205
Overall Study NOT COMPLETED	49	48	43

Reasons for withdrawal

Reasons for withdrawal
Measure	rMenB+ACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.	rMenB Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Overall Study Withdrawal by Subject	15	16	15
Overall Study Lost to Follow-up	25	20	13
Overall Study Other: Administrative Reason	8	5	12
Overall Study Other: Unspecified	1	4	2
Overall Study Adverse Event	0	2	1
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rMenB+ACWY Group n=252 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age.	rMenB Group n=250 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group n=248 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.	Total n=750 Participants Total of all reporting groups
Age, Continuous	104.0 Days STANDARD_DEVIATION 10.72 • n=5 Participants	101.4 Days STANDARD_DEVIATION 10.57 • n=7 Participants	102.7 Days STANDARD_DEVIATION 10.9 • n=5 Participants	102.7 Days STANDARD_DEVIATION 10.77 • n=4 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	118 Participants n=7 Participants	139 Participants n=5 Participants	377 Participants n=4 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	132 Participants n=7 Participants	109 Participants n=5 Participants	373 Participants n=4 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	54 Participants n=4 Participants
Race/Ethnicity, Customized Other	235 Participants n=5 Participants	230 Participants n=7 Participants	231 Participants n=5 Participants	696 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Population: Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=148 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=158 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains H44/76	92 Titers Interval 67.0 to 128.0	104 Titers Interval 77.0 to 141.0	—
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains 5/99	1850 Titers Interval 1122.0 to 3050.0	1790 Titers Interval 1128.0 to 2842.0	—
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains NZ98/254	39 Titers Interval 29.0 to 53.0	38 Titers Interval 28.0 to 52.0	—
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains M10713	13 Titers Interval 7.82 to 21.0	12 Titers Interval 7.72 to 20.0	—

PRIMARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=161 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=156 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y Serogroup A	409 Titers Interval 300.0 to 556.0	165 Titers Interval 122.0 to 224.0	—
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y Serogroup C	452 Titers Interval 312.0 to 655.0	421 Titers Interval 294.0 to 602.0	—
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y Serogroup W	721 Titers Interval 493.0 to 1053.0	536 Titers Interval 370.0 to 776.0	—
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	410 Titers Interval 293.0 to 575.0	391 Titers Interval 280.0 to 546.0	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (day 1).

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=191 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. H44/76	1.03 Titers Interval 0.99 to 1.08	1.02 Titers Interval 0.98 to 1.07	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. 5/99	1.09 Titers Interval 0.99 to 1.21	1.07 Titers Interval 0.97 to 1.17	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. NZ98/254	1.06 Titers Interval 1.01 to 1.12	1.07 Titers Interval 1.02 to 1.12	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. M10713	1.88 Titers Interval 1.51 to 2.34	1.59 Titers Interval 1.29 to 1.96	—

SECONDARY outcome

Timeframe: At Day 151 (one month after the third vaccination)

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. 5/99	891 Titers Interval 752.0 to 1055.0	935 Titers Interval 803.0 to 1088.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. H44/76	116 Titers Interval 100.0 to 135.0	129 Titers Interval 113.0 to 147.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. NZ98/254	32 Titers Interval 26.0 to 39.0	33 Titers Interval 27.0 to 40.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. M10713	9.09 Titers Interval 6.57 to 13.0	10 Titers Interval 7.5 to 14.0	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination( Day 301).

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=173 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. H44/76	7.68 Titers Interval 5.91 to 9.99	8.31 Titers Interval 6.54 to 11.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. 5/99	131 Titers Interval 107.0 to 161.0	109 Titers Interval 90.0 to 132.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. NZ98/254	3.21 Titers Interval 2.44 to 4.21	2.93 Titers Interval 2.25 to 3.81	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. M10713	2.48 Titers Interval 1.89 to 3.27	2.40 Titers Interval 1.85 to 3.1	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=196 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. H44/76	122 Titers Interval 98.0 to 151.0	126 Titers Interval 104.0 to 154.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. 5/99	1404 Titers Interval 1016.0 to 1939.0	1262 Titers Interval 934.0 to 1706.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. NZ98/254	37 Titers Interval 30.0 to 45.0	36 Titers Interval 30.0 to 44.0	—
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. M10713	18 Titers Interval 14.0 to 24.0	17 Titers Interval 13.0 to 22.0	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=213 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=210 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup A	2.05 Titers Interval 1.97 to 2.15	2.08 Titers Interval 1.99 to 2.17	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup C	2.16 Titers Interval 1.98 to 2.35	2.09 Titers Interval 1.92 to 2.27	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup W	2.33 Titers Interval 2.13 to 2.55	2.31 Titers Interval 2.11 to 2.52	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup Y	2.06 Titers Interval 1.95 to 2.17	2.16 Titers Interval 2.05 to 2.28	—

SECONDARY outcome

Timeframe: At Day 151 (one month after the third vaccination)

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=215 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=214 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup A	303 Titers Interval 242.0 to 379.0	136 Titers Interval 108.0 to 169.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup C	388 Titers Interval 320.0 to 469.0	416 Titers Interval 345.0 to 502.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup W	347 Titers Interval 282.0 to 427.0	298 Titers Interval 244.0 to 364.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	226 Titers Interval 182.0 to 282.0	283 Titers Interval 228.0 to 351.0	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=203 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup Y	38 Titers Interval 30.0 to 49.0	43 Titers Interval 33.0 to 55.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup A	20 Titers Interval 15.0 to 28.0	15 Titers Interval 11.0 to 21.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup C	31 Titers Interval 23.0 to 41.0	43 Titers Interval 32.0 to 58.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup W	48 Titers Interval 37.0 to 63.0	47 Titers Interval 36.0 to 62.0	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=199 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup A	329 Titers Interval 269.0 to 403.0	132 Titers Interval 108.0 to 161.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup C	331 Titers Interval 268.0 to 409.0	311 Titers Interval 252.0 to 384.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup W	576 Titers Interval 458.0 to 723.0	428 Titers Interval 342.0 to 537.0	—
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. Serogroup Y	377 Titers Interval 304.0 to 466.0	363 Titers Interval 294.0 to 448.0	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline(Day 1)

Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=191 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains H44/76	0 Percentage of subjects Interval 0.0 to 2.3	1 Percentage of subjects Interval 0.01 to 2.8	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains 5/99	1 Percentage of subjects Interval 0.15 to 4.5	1 Percentage of subjects Interval 0.13 to 3.7	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains NZ98/254	1 Percentage of subjects Interval 0.01 to 2.9	1 Percentage of subjects Interval 0.01 to 2.7	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains M10713	16 Percentage of subjects Interval 11.4 to 22.7	11 Percentage of subjects Interval 6.9 to 15.9	—

SECONDARY outcome

Timeframe: At Day 151 (one month after the third vaccination)

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151).

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains 5/99	100 Percentage of subjects Interval 97.3 to 100.0	100 Percentage of subjects Interval 98.1 to 100.0	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains H44/76	100 Percentage of subjects Interval 97.6 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains NZ98/254	96 Percentage of subjects Interval 92.2 to 98.4	97 Percentage of subjects Interval 93.7 to 98.9	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains M10713	70 Percentage of subjects Interval 62.7 to 77.0	68 Percentage of subjects Interval 61.1 to 74.3	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=173 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. H44/76	74 Percentage of subjects Interval 65.4 to 81.2	75 Percentage of subjects Interval 67.9 to 80.7	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. 5/99	100 Percentage of subjects Interval 97.4 to 100.0	97 Percentage of subjects Interval 93.9 to 99.1	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. NZ98/254	42 Percentage of subjects Interval 34.2 to 49.3	36 Percentage of subjects Interval 29.7 to 43.3	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. M10713	33 Percentage of subjects Interval 25.7 to 41.2	31 Percentage of subjects Interval 24.5 to 37.7	—

SECONDARY outcome

Timeframe: At Day 331 (One month after the fourth vaccination)

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=196 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. H44/76	100 Percentage of subjects Interval 97.4 to 100.0	99 Percentage of subjects Interval 97.1 to 99.99	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. 5/99	99 Percentage of subjects Interval 95.0 to 99.83	97 Percentage of subjects Interval 93.0 to 98.8	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. NZ98/254	100 Percentage of subjects Interval 98.0 to 100.0	98 Percentage of subjects Interval 94.9 to 99.4	—
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. M10713	87 Percentage of subjects Interval 80.8 to 91.7	87 Percentage of subjects Interval 81.6 to 91.5	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at baseline (day 1)

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=191 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains H44/76	0 Percentage of subjects Interval 0.0 to 2.3	0 Percentage of subjects Interval 0.0 to 1.8	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains 5/99	1 Percentage of subjects Interval 0.02 to 3.5	1 Percentage of subjects Interval 0.01 to 2.9	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains NZ98/254	1 Percentage of subjects Interval 0.01 to 2.9	1 Percentage of subjects Interval 0.01 to 2.7	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains M10713	12 Percentage of subjects Interval 7.3 to 17.1	8 Percentage of subjects Interval 4.6 to 12.5	—

SECONDARY outcome

Timeframe: At Day 151 (one month after the third vaccination)

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=206 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains H44/76	100 Percentage of subjects Interval 97.6 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains 5/99	100 Percentage of subjects Interval 97.3 to 100.0	100 Percentage of subjects Interval 98.1 to 100.0	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains NZ98/254	92 Percentage of subjects Interval 87.4 to 95.7	92 Percentage of subjects Interval 87.6 to 95.5	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains M10713	65 Percentage of subjects Interval 57.2 to 72.1	59 Percentage of subjects Interval 52.2 to 66.0	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=173 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains H44/76	58 Percentage of subjects Interval 49.5 to 67.0	56 Percentage of subjects Interval 48.9 to 63.5	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains 5/99	100 Percentage of subjects Interval 97.4 to 100.0	97 Percentage of subjects Interval 93.2 to 98.8	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains NZ98/254	26 Percentage of subjects Interval 19.6 to 33.2	26 Percentage of subjects Interval 20.6 to 33.1	—
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains M10713	21 Percentage of subjects Interval 14.4 to 27.9	23 Percentage of subjects Interval 17.5 to 29.7	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=181 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=196 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains M10713	83 Percentage of subjects Interval 76.5 to 88.6	82 Percentage of subjects Interval 76.4 to 87.5	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains H44/76	100 Percentage of subjects Interval 97.4 to 100.0	99 Percentage of subjects Interval 97.1 to 99.99	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains 5/99	99 Percentage of subjects Interval 95.0 to 99.83	97 Percentage of subjects Interval 93.0 to 98.8	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains NZ98/254	98 Percentage of subjects Interval 94.4 to 99.4	94 Percentage of subjects Interval 90.2 to 97.2	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=213 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=210 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	2 Percentage of subjects Interval 0.5 to 4.7	5 Percentage of subjects Interval 2.3 to 8.6	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	1 Percentage of subjects Interval 0.11 to 3.4	1 Percentage of subjects Interval 0.12 to 3.5	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	4 Percentage of subjects Interval 1.7 to 7.5	3 Percentage of subjects Interval 1.4 to 6.9	—
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	4 Percentage of subjects Interval 1.8 to 8.0	4 Percentage of subjects Interval 1.4 to 7.2	—

SECONDARY outcome

Timeframe: At Day 151 (one month after the third vaccination)

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=215 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=214 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	99 Percentage of subjects Interval 97.4 to 99.99	96 Percentage of subjects Interval 92.0 to 98.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	100 Percentage of subjects Interval 98.2 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	100 Percentage of subjects Interval 97.9 to 100.0	100 Percentage of subjects Interval 98.1 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	99 Percentage of subjects Interval 96.0 to 99.71	100 Percentage of subjects Interval 98.3 to 100.0	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=203 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	88 Percentage of subjects Interval 82.3 to 92.0	89 Percentage of subjects Interval 84.1 to 93.4	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	93 Percentage of subjects Interval 88.7 to 96.7	96 Percentage of subjects Interval 91.3 to 98.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	68 Percentage of subjects Interval 60.5 to 73.9	63 Percentage of subjects Interval 55.4 to 69.2	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	91 Percentage of subjects Interval 85.8 to 94.3	95 Percentage of subjects Interval 90.6 to 97.3	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=199 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	100 Percentage of subjects Interval 98.1 to 100.0	98 Percentage of subjects Interval 94.3 to 99.2	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	100 Percentage of subjects Interval 98.1 to 100.0	100 Percentage of subjects Interval 98.1 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	100 Percentage of subjects Interval 98.2 to 100.0	99 Percentage of subjects Interval 97.3 to 99.99	—

SECONDARY outcome

Timeframe: At Day 331 (one month after fourth vaccination)

Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 \& M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=155 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=195 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains H44/76	17 Ratio Interval 13.0 to 22.0	16 Ratio Interval 12.0 to 20.0	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains 5/99	9.60 Ratio Interval 6.99 to 13.0	12 Ratio Interval 8.86 to 16.0	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains NZ98/254	11 Ratio Interval 8.35 to 15.0	12 Ratio Interval 9.39 to 16.0	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains M10713	5.99 Ratio Interval 4.2 to 8.54	6.75 Ratio Interval 4.9 to 9.29	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 \& Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=197 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=201 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y Serogroup A	16 Ratio Interval 13.0 to 21.0	8.75 Ratio Interval 6.69 to 11.0	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y Serogroup C	11 Ratio Interval 8.86 to 14.0	7.79 Ratio Interval 6.25 to 9.71	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y Serogroup W	13 Ratio Interval 10.0 to 16.0	9.44 Ratio Interval 7.52 to 12.0	—
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y Serogroup Y	9.75 Ratio Interval 8.0 to 12.0	8.97 Ratio Interval 7.36 to 11.0	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was \<2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2).

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=155 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=195 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains H44/76	93 Percentage of subjects Interval 86.0 to 96.8	92 Percentage of subjects Interval 87.2 to 95.6	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains 5/99	94 Percentage of subjects Interval 88.2 to 97.6	95 Percentage of subjects Interval 90.9 to 97.9	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains NZ98/254	81 Percentage of subjects Interval 73.5 to 86.5	79 Percentage of subjects Interval 73.1 to 84.9	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains M10713	58 Percentage of subjects Interval 48.7 to 66.3	60 Percentage of subjects Interval 52.5 to 67.0	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W \& Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was \<4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4).

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=197 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=201 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup A	90 Percentage of subjects Interval 84.4 to 93.5	71 Percentage of subjects Interval 64.6 to 77.6	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup C	88 Percentage of subjects Interval 81.9 to 92.0	77 Percentage of subjects Interval 70.1 to 82.9	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup W	89 Percentage of subjects Interval 83.0 to 93.5	84 Percentage of subjects Interval 77.9 to 89.7	—
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	82 Percentage of subjects Interval 75.6 to 86.9	81 Percentage of subjects Interval 74.4 to 85.8	—

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=213 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=210 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	1 Percentage of subjects Interval 0.01 to 2.6	1 Percentage of subjects Interval 0.01 to 2.7	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	2 Percentage of subjects Interval 0.8 to 5.6	2 Percentage of subjects Interval 0.5 to 4.9	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	4 Percentage of subjects Interval 1.5 to 7.3	3 Percentage of subjects Interval 0.8 to 5.9	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	0 Percentage of subjects Interval 0.0 to 1.7	2 Percentage of subjects Interval 0.5 to 4.8	—

SECONDARY outcome

Timeframe: At Day 151 (one month before the third vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=215 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=214 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	99 Percentage of subjects Interval 97.4 to 99.99	96 Percentage of subjects Interval 92.0 to 98.0	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	100 Percentage of subjects Interval 98.2 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	100 Percentage of subjects Interval 97.9 to 100.0	99 Percentage of subjects Interval 97.1 to 99.99	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	98 Percentage of subjects Interval 95.3 to 99.5	99 Percentage of subjects Interval 97.4 to 99.99	—

SECONDARY outcome

Timeframe: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=203 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	65 Percentage of subjects Interval 58.0 to 71.6	58 Percentage of subjects Interval 50.8 to 64.9	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	77 Percentage of subjects Interval 70.5 to 82.7	85 Percentage of subjects Interval 79.3 to 89.9	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	92 Percentage of subjects Interval 86.5 to 95.4	91 Percentage of subjects Interval 85.8 to 94.8	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	86 Percentage of subjects Interval 80.1 to 90.2	91 Percentage of subjects Interval 85.8 to 94.3	—

SECONDARY outcome

Timeframe: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=199 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=204 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup A	100 Percentage of subjects Interval 98.1 to 100.0	96 Percentage of subjects Interval 92.4 to 98.3	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup C	99 Percentage of subjects Interval 97.1 to 99.99	100 Percentage of subjects Interval 98.1 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup W	100 Percentage of subjects Interval 98.0 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	—
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y Serogroup Y	98 Percentage of subjects Interval 95.7 to 99.69	99 Percentage of subjects Interval 97.3 to 99.99	—

SECONDARY outcome

Timeframe: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)

Population: Analysis was performed on the Solicited Safety Set. The solicited safety set included all subjects who provide informed consent \& provide demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post vaccination solicited adverse events data

Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=240 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=232 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group n=237 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Any	235 Participants	226 Participants	194 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Any local	220 Participants	214 Participants	157 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Sleepiness (vaccination 4)	50 Participants	37 Participants	33 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Treatment of Pain/Fever (vaccination 2)	74 Participants	91 Participants	29 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Erythema (vaccination 3)	86 Participants	96 Participants	35 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Induration (vaccination 3)	92 Participants	103 Participants	30 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Swelling (vaccination 3)	73 Participants	82 Participants	19 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Tenderness (vaccination 3)	139 Participants	128 Participants	59 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Change in Eating Habits (vaccination 3)	42 Participants	45 Participants	33 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Any Systemic	217 Participants	217 Participants	178 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Erythema (vaccination 1)	101 Participants	102 Participants	44 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Induration (vaccination 1)	111 Participants	102 Participants	22 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Swelling (vaccination 1)	82 Participants	86 Participants	22 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Tenderness (vaccination 1)	162 Participants	159 Participants	73 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Change in Eating Habits (vaccination 1)	53 Participants	47 Participants	34 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Diarrhea (vaccination 1)	46 Participants	41 Participants	42 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Irritability (vaccination 1)	111 Participants	121 Participants	87 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Persistent Crying (vaccination 1)	124 Participants	132 Participants	85 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Rash (vaccination 1)	19 Participants	28 Participants	18 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Sleepiness (vaccination 1)	69 Participants	78 Participants	54 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Vomiting (vaccination 1)	14 Participants	28 Participants	23 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fever (vaccination 1)	49 Participants	54 Participants	10 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Treatment of Pain/Fever (vaccination 1)	82 Participants	98 Participants	25 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Erythema (vaccination 2)	97 Participants	102 Participants	47 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Induration (vaccination 2)	99 Participants	110 Participants	32 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Swelling (vaccination 2)	78 Participants	83 Participants	24 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Tenderness (vaccination 2)	142 Participants	138 Participants	66 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Change in Eating Habits (vaccination 2)	46 Participants	44 Participants	31 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Diarrhea (vaccination 2)	37 Participants	36 Participants	24 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Irritability (vaccination 2)	99 Participants	95 Participants	70 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Persistent Crying (vaccination 2)	104 Participants	108 Participants	66 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Rash (vaccination 2)	16 Participants	21 Participants	13 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Sleepiness (vaccination 2)	51 Participants	55 Participants	45 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Vomiting (vaccination 2)	10 Participants	21 Participants	17 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fever (vaccination 2)	48 Participants	54 Participants	15 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Diarrhea (vaccination 3)	24 Participants	40 Participants	25 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Irritability (vaccination 3)	83 Participants	84 Participants	61 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Persistent Crying (vaccination 3)	90 Participants	92 Participants	60 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Rash (vaccination 3)	10 Participants	11 Participants	11 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Sleepiness (vaccination 3)	39 Participants	46 Participants	39 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Vomiting (vaccination 3)	7 Participants	27 Participants	14 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fever (vaccination 3)	37 Participants	38 Participants	25 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Treatment of Pain/Fever (vaccination 3)	57 Participants	69 Participants	31 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Erythema (vaccination 4)	73 Participants	88 Participants	37 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Induration (vaccination 4)	84 Participants	93 Participants	29 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Swelling (vaccination 4)	75 Participants	74 Participants	21 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Tenderness (vaccination 4)	126 Participants	129 Participants	64 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Change in Eating Habits (vaccination 4)	59 Participants	45 Participants	40 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Diarrhea (vaccination 4)	29 Participants	28 Participants	23 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Irritability (vaccination 4)	81 Participants	74 Participants	57 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Persistent Crying (vaccination 4)	84 Participants	89 Participants	56 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Rash (vaccination 4)	11 Participants	13 Participants	6 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Vomiting (vaccination 4)	15 Participants	14 Participants	11 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fever (vaccination 4)	53 Participants	46 Participants	19 Participants
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Treatment of Pain/Fever (vaccination 4)	71 Participants	67 Participants	31 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)

Population: Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent \& demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record

An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=249 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=249 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group n=246 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Number of Subjects With Unsolicited Adverse Events Any	103 Participants	116 Participants	70 Participants
Number of Subjects With Unsolicited Adverse Events Any unsolicited AEs( vaccination 1)	63 Participants	62 Participants	20 Participants
Number of Subjects With Unsolicited Adverse Events Any unsolicited AEs( vaccination 2)	60 Participants	69 Participants	29 Participants
Number of Subjects With Unsolicited Adverse Events Any unsolicited AEs( vaccination 3)	57 Participants	63 Participants	23 Participants
Number of Subjects With Unsolicited Adverse Events Any unsolicited AEs( vaccination 4)	44 Participants	58 Participants	13 Participants

SECONDARY outcome

Timeframe: Throughout the whole study period (from Day 1 upto Day 331)

A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.

Outcome measures

Outcome measures
Measure	rMenB+ACWY Group n=249 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age	rMenB Group n=249 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.	MenACWY Group n=246 Participants Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age.
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) Any SAEs	6 Participants	13 Participants	11 Participants
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) Any Medically Attended AEs	177 Participants	188 Participants	183 Participants
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) Any AEs leading to premature withdrawal	0 Participants	2 Participants	1 Participants

Adverse Events

rMenB+ACWY Group

Serious events: 6 serious events

Other events: 240 other events

Deaths: 0 deaths

rMenB Group

Serious events: 13 serious events

Other events: 232 other events

Deaths: 0 deaths

MenACWY Group

Serious events: 11 serious events

Other events: 221 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