Trial Outcomes & Findings for Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years (NCT NCT03587207)

Last Updated: 2020-02-12

Results Overview

hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

520 participants

Primary outcome timeframe

1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group

Results posted on

2020-02-12

Participant Flow

Subjects were recruited from 1 center at Czechia.

Out of the total 520 subjects enrolled in this study, 500 subjects received the vaccination. Among the 20 subjects that were not vaccinated, 15 did not fuflill eligibility criteria and 5 were excluded due to other reasons.

Participant milestones

Participant milestones
Measure	MenABCWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Overall Study STARTED	100	104	100	94	102
Overall Study COMPLETED	100	104	100	94	102
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenABCWY Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.	Total n=500 Participants Total of all reporting groups
Age, Continuous	17.1 Years STANDARD_DEVIATION 4.34 • n=5 Participants	16.9 Years STANDARD_DEVIATION 4.28 • n=7 Participants	17.1 Years STANDARD_DEVIATION 4.49 • n=5 Participants	17.4 Years STANDARD_DEVIATION 4.64 • n=4 Participants	17.1 Years STANDARD_DEVIATION 4.57 • n=21 Participants	17.1 Years STANDARD_DEVIATION 4.45 • n=10 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	53 Participants n=4 Participants	49 Participants n=21 Participants	246 Participants n=10 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	56 Participants n=7 Participants	51 Participants n=5 Participants	41 Participants n=4 Participants	53 Participants n=21 Participants	254 Participants n=10 Participants
Race/Ethnicity, Customized Race · WHITE	100 Participants n=5 Participants	104 Participants n=7 Participants	100 Participants n=5 Participants	94 Participants n=4 Participants	102 Participants n=21 Participants	500 Participants n=10 Participants

PRIMARY outcome

Timeframe: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group

Population: Analysis performed on Per Protocol Set(PPS) for immunogenicity that included subjects without major protocol violations \& whose assay results were available for atleast 1 serogroup/B strain at Day 91 for all study groups except MenACWY group that was not considered for this analysis as only serogroup B strains were assessed in this outcome measure

Outcome measures

Outcome measures
Measure	MenABCWY Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.	31.84 titers Interval 28.18 to 35.98	38.48 titers Interval 34.23 to 43.26	40.08 titers Interval 35.44 to 45.33	42.38 titers Interval 37.31 to 48.13	—

PRIMARY outcome

Timeframe: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group.

hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=101 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis B M14459 (fHbp)	23.91 titers Interval 20.52 to 27.86	23.34 titers Interval 20.16 to 27.01	23.23 titers Interval 19.91 to 27.1	22.87 titers Interval 19.52 to 26.8	2.48 titers Interval 2.13 to 2.89
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis B 96217(NadA)	81.09 titers Interval 69.24 to 94.97	102.68 titers Interval 88.24 to 119.5	97.54 titers Interval 83.18 to 114.39	113.54 titers Interval 96.25 to 133.93	4.15 titers Interval 3.54 to 4.86
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis B NZ98/254(PorA)	12.97 titers Interval 10.89 to 15.45	16.39 titers Interval 13.86 to 19.39	21.12 titers Interval 17.71 to 25.18	20.97 titers Interval 17.47 to 25.16	2.15 titers Interval 1.81 to 2.57
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis B M07-0241084(NHBA)	13.08 titers Interval 11.09 to 15.43	18.00 titers Interval 15.35 to 21.11	22.59 titers Interval 19.12 to 26.69	25.34 titers Interval 21.3 to 30.13	4.08 titers Interval 3.45 to 4.82
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis A	104.90 titers Interval 87.02 to 126.47	187.52 titers Interval 156.94 to 224.05	204.01 titers Interval 169.06 to 246.18	94.91 titers Interval 78.26 to 115.12	52.03 titers Interval 43.01 to 62.95
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis C	172.99 titers Interval 140.43 to 213.09	144.80 titers Interval 118.48 to 176.97	145.42 titers Interval 117.91 to 179.34	32.01 titers Interval 25.75 to 39.79	34.66 titers Interval 28.09 to 42.78
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis W	260.11 titers Interval 219.31 to 308.51	245.63 titers Interval 208.4 to 289.52	254.20 titers Interval 213.76 to 302.3	193.58 titers Interval 161.68 to 231.76	80.11 titers Interval 67.42 to 95.19
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination. Meningitis Y	219.52 titers Interval 173.1 to 278.39	186.08 titers Interval 148.25 to 233.55	204.92 titers Interval 161.4 to 260.16	3.66 titers Interval 2.86 to 4.69	92.41 titers Interval 72.75 to 117.37

PRIMARY outcome

Timeframe: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Outcome measures

Outcome measures
Measure	MenABCWY Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=101 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis B M07-0241084 (NHBA)	59.2 Percentage of subjects Interval 52.22 to 65.86	74.0 Percentage of subjects Interval 67.54 to 79.71	77.1 Percentage of subjects Interval 70.66 to 82.62	80.9 Percentage of subjects Interval 74.48 to 86.22	23.2 Percentage of subjects Interval 17.57 to 29.64
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis A	94.8 Percentage of subjects Interval 90.65 to 97.47	100.0 Percentage of subjects Interval 97.75 to 100.0	99.0 Percentage of subjects Interval 96.05 to 99.89	91.1 Percentage of subjects Interval 85.96 to 94.76	68.8 Percentage of subjects Interval 61.86 to 75.15
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis B M14459 (fHbp)	83.5 Percentage of subjects Interval 77.64 to 88.28	86.0 Percentage of subjects Interval 80.5 to 90.35	88.5 Percentage of subjects Interval 83.22 to 92.57	83.3 Percentage of subjects Interval 77.18 to 88.31	12.4 Percentage of subjects Interval 8.21 to 17.78
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Mengitis B 96217(NadA)	96.9 Percentage of subjects Interval 93.31 to 98.87	99.0 Percentage of subjects Interval 96.17 to 99.89	99.0 Percentage of subjects Interval 96.05 to 99.89	100.0 Percentage of subjects Interval 97.47 to 100.0	33.3 Percentage of subjects Interval 26.96 to 40.24
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis B NZ98/254 (PorA)	59.2 Percentage of subjects Interval 52.22 to 65.86	76.0 Percentage of subjects Interval 69.66 to 81.53	80.4 Percentage of subjects Interval 74.27 to 85.57	78.7 Percentage of subjects Interval 72.05 to 84.23	5.2 Percentage of subjects Interval 2.53 to 9.35
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis C	100.0 Percentage of subjects Interval 97.68 to 100.0	100.0 Percentage of subjects Interval 97.72 to 100.0	100.0 Percentage of subjects Interval 97.65 to 100.0	96.7 Percentage of subjects Interval 92.73 to 98.77	86.6 Percentage of subjects Interval 81.06 to 90.92
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Meningitis W	98.0 Percentage of subjects Interval 94.66 to 99.46	96.0 Percentage of subjects Interval 92.17 to 98.24	99.0 Percentage of subjects Interval 96.01 to 99.89	93.3 Percentage of subjects Interval 88.59 to 96.46	66.0 Percentage of subjects Interval 59.09 to 72.36
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination. Menngitis Y	99.0 Percentage of subjects Interval 96.05 to 99.89	98.0 Percentage of subjects Interval 94.77 to 99.47	96.9 Percentage of subjects Interval 93.24 to 98.86	24.7 Percentage of subjects Interval 18.79 to 31.54	85.4 Percentage of subjects Interval 79.71 to 89.94

PRIMARY outcome

Timeframe: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Outcome measures

Outcome measures
Measure	MenABCWY Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B M14459 (fHbp)	66.0 Percentage of subjects Interval 59.09 to 72.36	69.0 Percentage of subjects Interval 62.32 to 75.09	66.3 Percentage of subjects Interval 59.36 to 72.74	63.3 Percentage of subjects Interval 56.09 to 70.11	2.1 Percentage of subjects Interval 0.55 to 5.39
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B 96217(NadA)	80.4 Percentage of subjects Interval 74.27 to 85.57	88.0 Percentage of subjects Interval 82.74 to 92.04	90.5 Percentage of subjects Interval 85.46 to 94.2	80.7 Percentage of subjects Interval 74.2 to 86.06	2.1 Percentage of subjects Interval 0.56 to 5.45
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B NZ98/254 (PorA)	48.0 Percentage of subjects Interval 41.06 to 54.92	60.0 Percentage of subjects Interval 53.11 to 66.58	58.8 Percentage of subjects Interval 51.75 to 65.49	60.7 Percentage of subjects Interval 53.35 to 67.63	1.0 Percentage of subjects Interval 0.11 to 3.95
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B M07-0241084(NHBA)	21.4 Percentage of subjects Interval 16.1 to 27.68	38.8 Percentage of subjects Interval 32.18 to 45.72	42.1 Percentage of subjects Interval 35.27 to 49.2	56.3 Percentage of subjects Interval 48.88 to 63.54	2.1 Percentage of subjects Interval 0.57 to 5.56
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis A	92.7 Percentage of subjects Interval 88.04 to 95.9	99.0 Percentage of subjects Interval 96.17 to 99.89	98.9 Percentage of subjects Interval 95.97 to 99.89	87.8 Percentage of subjects Interval 82.14 to 92.06	67.4 Percentage of subjects Interval 60.34 to 73.85
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis C	90.8 Percentage of subjects Interval 85.89 to 94.38	91.9 Percentage of subjects Interval 87.21 to 95.24	86.6 Percentage of subjects Interval 81.06 to 90.92	57.3 Percentage of subjects Interval 49.95 to 64.4	52.1 Percentage of subjects Interval 45.05 to 59.05
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis W	83.3 Percentage of subjects Interval 77.41 to 88.15	78.6 Percentage of subjects Interval 72.32 to 83.9	74.2 Percentage of subjects Interval 67.48 to 80.1	74.1 Percentage of subjects Interval 67.04 to 80.3	41.1 Percentage of subjects Interval 34.26 to 48.14
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis Y	95.9 Percentage of subjects Interval 91.93 to 98.19	91.9 Percentage of subjects Interval 87.21 to 95.24	93.7 Percentage of subjects Interval 89.18 to 96.65	11.4 Percentage of subjects Interval 7.19 to 16.97	76.8 Percentage of subjects Interval 70.36 to 82.43

PRIMARY outcome

Timeframe: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).

hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B M14459 (fHbp)	11.17 Ratio Interval 9.59 to 13.02	10.90 Ratio Interval 9.42 to 12.62	10.85 Ratio Interval 9.3 to 12.66	10.69 Ratio Interval 9.12 to 12.52	1.16 Ratio Interval 0.99 to 1.35
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B 96217(NadA)	21.33 Ratio Interval 18.22 to 24.99	27.02 Ratio Interval 23.22 to 31.44	25.66 Ratio Interval 21.88 to 30.1	29.87 Ratio Interval 25.32 to 35.24	1.09 Ratio Interval 0.93 to 1.28
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B NZ98/254(PorA)	7.28 Ratio Interval 6.11 to 8.67	9.20 Ratio Interval 7.78 to 10.88	11.85 Ratio Interval 9.94 to 14.13	11.77 Ratio Interval 9.81 to 14.12	1.21 Ratio Interval 1.01 to 1.44
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis B M07-0241084(NHBA)	3.60 Ratio Interval 3.05 to 4.25	4.96 Ratio Interval 4.23 to 5.81	6.22 Ratio Interval 5.27 to 7.35	6.98 Ratio Interval 5.87 to 8.3	1.12 Ratio Interval 0.95 to 1.33
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis A	33.21 Ratio Interval 27.55 to 40.04	59.36 Ratio Interval 49.68 to 70.93	64.58 Ratio Interval 53.52 to 77.93	30.05 Ratio Interval 24.77 to 36.44	16.47 Ratio Interval 13.62 to 19.93
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis C	34.34 Ratio Interval 27.88 to 42.3	28.74 Ratio Interval 23.52 to 35.13	28.86 Ratio Interval 23.4 to 35.6	6.35 Ratio Interval 5.11 to 7.9	6.88 Ratio Interval 5.58 to 8.49
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis W	24.58 Ratio Interval 20.72 to 29.15	23.21 Ratio Interval 19.69 to 27.36	24.02 Ratio Interval 20.2 to 28.56	18.29 Ratio Interval 15.28 to 21.9	7.57 Ratio Interval 6.37 to 8.99
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination. Meningitis Y	106.87 Ratio Interval 84.27 to 135.53	90.59 Ratio Interval 72.18 to 113.7	99.76 Ratio Interval 78.58 to 126.66	1.78 Ratio Interval 1.39 to 2.28	44.99 Ratio Interval 35.42 to 57.14

SECONDARY outcome

Timeframe: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain after first vaccination for all study groups except for MenACWY group that was not considered for this analysis as only serogroup B strains assessed in this outcome.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=96 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=103 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=91 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination	6.51 Titers Interval 5.63 to 7.52	8.33 Titers Interval 7.24 to 9.58	8.16 Titers Interval 7.08 to 9.41	9.45 Titers Interval 8.14 to 10.95	—

SECONDARY outcome

Timeframe: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/ B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 2).

Outcome measures

Outcome measures
Measure	MenABCWY Group n=96 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=103 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=91 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis B M14459(fHbp)	5.50 Titers Interval 4.55 to 6.66	6.36 Titers Interval 5.29 to 7.65	4.94 Titers Interval 4.09 to 5.96	6.08 Titers Interval 5.0 to 7.39	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis B 96217 (NadA)	8.21 Titers Interval 6.87 to 9.81	11.30 Titers Interval 9.51 to 13.42	12.18 Titers Interval 10.23 to 14.52	14.07 Titers Interval 11.72 to 16.89	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis B NZ98/254 (PorA)	3.79 Titers Interval 3.1 to 4.63	4.83 Titers Interval 3.98 to 5.86	4.76 Titers Interval 3.91 to 5.79	5.48 Titers Interval 4.47 to 6.71	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis B M07-0241084 (NHBA)	6.27 Titers Interval 5.23 to 7.52	7.31 Titers Interval 6.12 to 8.73	6.75 Titers Interval 5.65 to 8.06	7.69 Titers Interval 6.38 to 9.26	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis A	31.38 Titers Interval 24.79 to 39.73	67.95 Titers Interval 54.07 to 85.4	88.29 Titers Interval 69.95 to 111.44	8.22 Titers Interval 6.48 to 10.44	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis C	41.35 Titers Interval 32.39 to 52.79	33.76 Titers Interval 26.61 to 42.85	40.33 Titers Interval 31.71 to 51.29	11.47 Titers Interval 8.92 to 14.74	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis W	108.91 Titers Interval 88.67 to 133.78	81.38 Titers Interval 66.62 to 99.42	92.84 Titers Interval 75.75 to 113.8	42.99 Titers Interval 34.66 to 53.33	—
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination. Meningitis Y	75.07 Titers Interval 56.86 to 99.13	76.48 Titers Interval 58.31 to 100.32	100.30 Titers Interval 76.13 to 132.15	3.98 Titers Interval 3.0 to 5.3	—

SECONDARY outcome

Timeframe: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 3).

Outcome measures

Outcome measures
Measure	MenABCWY Group n=96 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=103 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=98 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=91 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M14459 (fHbp)	36.8 Percentage of subjects Interval 30.24 to 43.88	49.5 Percentage of subjects Interval 42.77 to 56.27	37.8 Percentage of subjects Interval 31.21 to 44.69	42.2 Percentage of subjects Interval 35.19 to 49.53	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B 96217 (NadA)	57.3 Percentage of subjects Interval 50.24 to 64.11	66.0 Percentage of subjects Interval 59.35 to 72.2	69.4 Percentage of subjects Interval 62.65 to 75.51	75.8 Percentage of subjects Interval 69.12 to 81.64	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B NZ98/254 (PorA)	29.2 Percentage of subjects Interval 23.08 to 35.93	37.9 Percentage of subjects Interval 31.48 to 44.61	33.7 Percentage of subjects Interval 27.35 to 40.51	37.8 Percentage of subjects Interval 30.94 to 45.04	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M07-0241084 (NHBA)	35.1 Percentage of subjects Interval 28.56 to 42.14	49.5 Percentage of subjects Interval 42.69 to 56.33	37.5 Percentage of subjects Interval 30.9 to 44.51	44.4 Percentage of subjects Interval 37.33 to 51.75	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis A	65.3 Percentage of subjects Interval 58.28 to 71.75	73.5 Percentage of subjects Interval 67.12 to 79.22	80.2 Percentage of subjects Interval 74.01 to 85.41	25.6 Percentage of subjects Interval 19.58 to 32.38	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis C	89.6 Percentage of subjects Interval 84.41 to 93.42	94.1 Percentage of subjects Interval 89.9 to 96.88	92.8 Percentage of subjects Interval 88.16 to 95.94	70.0 Percentage of subjects Interval 62.96 to 76.35	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis W	71.9 Percentage of subjects Interval 65.16 to 77.88	70.6 Percentage of subjects Interval 64.04 to 76.51	74.2 Percentage of subjects Interval 67.67 to 80.0	52.3 Percentage of subjects Interval 44.9 to 59.56	—
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis Y	83.2 Percentage of subjects Interval 77.18 to 88.02	81.8 Percentage of subjects Interval 75.86 to 86.76	88.4 Percentage of subjects Interval 83.05 to 92.49	20.0 Percentage of subjects Interval 14.6 to 26.45	—

SECONDARY outcome

Timeframe: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 4).

Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise is defined as: a) for individuals whose pre-vaccination titers were less than (\<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (\<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).

Outcome measures

Outcome measures
Measure	MenABCWY Group n=96 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=103 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=91 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M14459 (fHbp)	24.2 Percentage of subjects Interval 18.52 to 30.76	24.3 Percentage of subjects Interval 18.8 to 30.53	18.8 Percentage of subjects Interval 13.67 to 24.86	25.6 Percentage of subjects Interval 19.58 to 32.38	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B 96217 (NadA)	22.1 Percentage of subjects Interval 16.62 to 28.51	34.0 Percentage of subjects Interval 27.8 to 40.65	30.5 Percentage of subjects Interval 24.31 to 37.38	32.6 Percentage of subjects Interval 26.01 to 39.77	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B NZ98/254 (PorA)	20.8 Percentage of subjects Interval 15.51 to 27.11	26.2 Percentage of subjects Interval 20.57 to 32.58	26.8 Percentage of subjects Interval 20.94 to 33.42	27.8 Percentage of subjects Interval 21.6 to 34.72	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M07-0241084 (NHBA)	9.6 Percentage of subjects Interval 5.86 to 14.69	20.6 Percentage of subjects Interval 15.35 to 26.84	13.8 Percentage of subjects Interval 9.37 to 19.52	20.5 Percentage of subjects Interval 14.94 to 27.03	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis A	61.7 Percentage of subjects Interval 54.6 to 68.42	71.3 Percentage of subjects Interval 64.73 to 77.18	80.6 Percentage of subjects Interval 74.37 to 85.88	23.3 Percentage of subjects Interval 17.57 to 30.03	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis C	54.2 Percentage of subjects Interval 47.11 to 61.09	46.5 Percentage of subjects Interval 39.78 to 53.39	51.0 Percentage of subjects Interval 44.02 to 58.03	24.7 Percentage of subjects Interval 18.79 to 31.54	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis W	60.6 Percentage of subjects Interval 53.53 to 67.4	52.0 Percentage of subjects Interval 45.12 to 58.82	51.6 Percentage of subjects Interval 44.46 to 58.71	39.8 Percentage of subjects Interval 32.53 to 47.37	—
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis Y	77.9 Percentage of subjects Interval 71.49 to 83.38	75.5 Percentage of subjects Interval 69.06 to 81.14	78.3 Percentage of subjects Interval 71.76 to 83.79	9.0 Percentage of subjects Interval 5.3 to 14.19	—

SECONDARY outcome

Timeframe: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)

Population: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 5).

hSBA mean ratios at 1 month after the first vaccination versus baseline were calculated in terms of GMRs. i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after first vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted mean were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=96 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=103 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=97 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=90 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis A	10.15 Ratio Interval 8.02 to 12.85	21.97 Ratio Interval 17.48 to 27.62	28.55 Ratio Interval 22.62 to 36.04	2.66 Ratio Interval 2.09 to 3.38	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis C	8.08 Ratio Interval 6.33 to 10.31	6.59 Ratio Interval 5.2 to 8.37	7.88 Ratio Interval 6.19 to 10.02	2.24 Ratio Interval 1.74 to 2.88	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M14459 (fHbp)	2.59 Ratio Interval 2.14 to 3.14	3.00 Ratio Interval 2.49 to 3.61	2.33 Ratio Interval 1.93 to 2.81	2.87 Ratio Interval 2.36 to 3.48	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B 96217(NadA)	2.15 Ratio Interval 1.8 to 2.57	2.96 Ratio Interval 2.49 to 3.51	3.19 Ratio Interval 2.68 to 3.8	3.68 Ratio Interval 3.07 to 4.42	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B NZ98/254 (PorA)	2.16 Ratio Interval 1.77 to 2.64	2.76 Ratio Interval 2.27 to 3.34	2.72 Ratio Interval 2.23 to 3.31	3.13 Ratio Interval 2.55 to 3.83	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis B M07-0241084 (NHBA)	1.73 Ratio Interval 1.44 to 2.07	2.01 Ratio Interval 1.69 to 2.41	1.86 Ratio Interval 1.56 to 2.22	2.12 Ratio Interval 1.76 to 2.55	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis W	11.08 Ratio Interval 9.02 to 13.6	8.28 Ratio Interval 6.77 to 10.11	9.44 Ratio Interval 7.7 to 11.57	4.37 Ratio Interval 3.52 to 5.42	—
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination Meningitis Y	36.58 Ratio Interval 27.7 to 48.3	37.26 Ratio Interval 28.41 to 48.88	48.87 Ratio Interval 37.09 to 64.39	1.94 Ratio Interval 1.46 to 2.58	—

SECONDARY outcome

Timeframe: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)

Population: Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination \& was reported with any solicited adverse event data.No results for dose 2 categories for subjects of MenACWY Group as they received only 1 dose at day 1.

Assessed local AEs were erythema, swelling, induration and pain. Any erythema, swelling and induration is defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Number of Subjects With Any Solicited Local Adverse Events (AEs) Erythema at Dose 1	17 Participants	19 Participants	18 Participants	9 Participants	7 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Swelling at Dose 1	20 Participants	21 Participants	16 Participants	13 Participants	10 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Induration at Dose 1	9 Participants	15 Participants	12 Participants	6 Participants	4 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Pain at Dose 1	89 Participants	100 Participants	95 Participants	88 Participants	52 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Erythema at Dose 2	15 Participants	18 Participants	15 Participants	10 Participants	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) Swelling at Dose 2	13 Participants	14 Participants	15 Participants	12 Participants	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) Induration at Dose 2	6 Participants	11 Participants	12 Participants	12 Participants	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) Pain at Dose 2	87 Participants	97 Participants	95 Participants	87 Participants	—

SECONDARY outcome

Population: Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination \& was reported with any solicited adverse event data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.

Assessed systemic AEs were arthralgia, fatigue, nausea, headache, myalgia and fever. Any fever is defined as body temperature equal or greater than 38 degrees Celsius.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Number of Subjects With Any Solicited Systemic AEs Headache at Dose 2	52 Participants	36 Participants	37 Participants	39 Participants	—
Number of Subjects With Any Solicited Systemic AEs Arthralgia at Dose 1	20 Participants	15 Participants	9 Participants	9 Participants	18 Participants
Number of Subjects With Any Solicited Systemic AEs Fatigue at Dose 1	56 Participants	61 Participants	55 Participants	46 Participants	50 Participants
Number of Subjects With Any Solicited Systemic AEs Nausea at Dose 1	16 Participants	23 Participants	14 Participants	13 Participants	14 Participants
Number of Subjects With Any Solicited Systemic AEs Headache at Dose 1	40 Participants	46 Participants	38 Participants	36 Participants	36 Participants
Number of Subjects With Any Solicited Systemic AEs Myalgia at Dose 1	34 Participants	29 Participants	27 Participants	21 Participants	28 Participants
Number of Subjects With Any Solicited Systemic AEs Fever at Dose 1	6 Participants	5 Participants	5 Participants	1 Participants	3 Participants
Number of Subjects With Any Solicited Systemic AEs Arthralgia at Dose 2	22 Participants	19 Participants	12 Participants	17 Participants	—
Number of Subjects With Any Solicited Systemic AEs Fatigue at Dose 2	58 Participants	61 Participants	62 Participants	56 Participants	—
Number of Subjects With Any Solicited Systemic AEs Nausea at Dose 2	16 Participants	13 Participants	15 Participants	17 Participants	—
Number of Subjects With Any Solicited Systemic AEs Myalgia at Dose 2	41 Participants	38 Participants	35 Participants	38 Participants	—
Number of Subjects With Any Solicited Systemic AEs Fever at Dose 2	6 Participants	3 Participants	3 Participants	1 Participants	—

SECONDARY outcome

Timeframe: During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)

Population: Analysis was performed on unsolicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received any study vaccination \& was reported with any unsolicited AE data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subjects/parent(s)/ Legally Acceptable Representative who has signed the informed consent or a solicited local or systemic adverse event that continues beyond the solicited period at day 7 after vaccination.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Number of Subjects With Unsolicited AEs Any unsolicited AEs- Dose 1	16 Participants	19 Participants	16 Participants	16 Participants	15 Participants
Number of Subjects With Unsolicited AEs Any unsolicited AEs- Dose 2	11 Participants	14 Participants	13 Participants	10 Participants	—

SECONDARY outcome

Timeframe: During the whole study period i.e from Day 1 to Day 91

Population: Analysis was performed on the unsolicited safety set that included all subjects who provided informed consent, underwent screening procedures, had a subject number assigned, received any study vaccination and was reported with any adverse event data.

SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Medically attended AEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.

Outcome measures

Outcome measures
Measure	MenABCWY Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 Participants Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs) SAE(s)	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs) MAE(s)	14 Participants	17 Participants	14 Participants	13 Participants	6 Participants
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs) AE(s) leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs) AESI(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

MenABCWY Group

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

rMenBOMV+ACWY_S Group

Serious events: 2 serious events

Other events: 103 other events

Deaths: 0 deaths

rMenBOMV+ACWY_D Group

Serious events: 1 serious events

Other events: 98 other events

Deaths: 0 deaths

rMenBOMV Group

Serious events: 2 serious events

Other events: 94 other events

Deaths: 0 deaths

MenACWY Group

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenABCWY Group n=100 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Injury, poisoning and procedural complications Concussion	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.9% 2/104 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Syncope	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).

Other adverse events

Other adverse events
Measure	MenABCWY Group n=100 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_S Group n=104 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).	rMenBOMV+ACWY_D Group n=100 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).	rMenBOMV Group n=94 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).	MenACWY Group n=102 participants at risk Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.
Infections and infestations Upper respiratory tract infection	5.0% 5/100 • Number of events 5 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.9% 3/104 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	3.2% 3/94 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.9% 3/102 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Viral infection	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Gastroenteritis	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Syncope	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.9% 2/104 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.1% 2/94 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Tonsillitis	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Bronchitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Rhinitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.0% 2/102 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Lyme disease	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Otitis externa	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Skin infection	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Face oedema	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Fatigue	70.0% 70/100 • Number of events 114 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	71.2% 74/104 • Number of events 122 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	72.0% 72/100 • Number of events 117 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	67.0% 63/94 • Number of events 102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	49.0% 50/102 • Number of events 50 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Inflammation	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Toothache	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.1% 2/94 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Abdominal pain	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Anal fissure	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Dyspepsia	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Enteritis	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Gastritis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Nausea	24.0% 24/100 • Number of events 32 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	25.0% 26/104 • Number of events 36 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	26.0% 26/100 • Number of events 29 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	27.7% 26/94 • Number of events 30 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	13.7% 14/102 • Number of events 14 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Arthralgia	29.0% 29/100 • Number of events 42 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	27.9% 29/104 • Number of events 34 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	18.0% 18/100 • Number of events 21 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	20.2% 19/94 • Number of events 26 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	17.6% 18/102 • Number of events 18 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Tendonitis	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Ligament sprain	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.1% 2/94 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Contusion	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Pericoronitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Pharyngitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Pharyngitis streptococcal	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Viral pharyngitis	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Migraine	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.9% 2/104 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	3.2% 3/94 • Number of events 4 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Musculoskeletal and connective tissue disorders Myalgia	50.0% 50/100 • Number of events 75 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	47.1% 49/104 • Number of events 67 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	45.0% 45/100 • Number of events 64 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	43.6% 41/94 • Number of events 59 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	27.5% 28/102 • Number of events 28 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Head injury	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Limb injury	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Skin and subcutaneous tissue disorders Urticaria	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Psychiatric disorders Depression	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Paronychia	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Gastrointestinal disorders Diarrhoea	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.0% 2/102 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site pain	94.0% 94/100 • Number of events 176 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	98.1% 102/104 • Number of events 197 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	97.0% 97/100 • Number of events 190 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	98.9% 93/94 • Number of events 175 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	52.0% 53/102 • Number of events 53 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Erythema	50.0% 50/100 • Number of events 78 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	68.3% 71/104 • Number of events 108 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	57.0% 57/100 • Number of events 82 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	61.7% 58/94 • Number of events 81 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	27.5% 28/102 • Number of events 28 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Swelling	51.0% 51/100 • Number of events 80 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	60.6% 63/104 • Number of events 98 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	46.0% 46/100 • Number of events 69 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	48.9% 46/94 • Number of events 65 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	22.5% 23/102 • Number of events 23 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Induration	44.0% 44/100 • Number of events 65 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	51.9% 54/104 • Number of events 85 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	49.0% 49/100 • Number of events 72 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	40.4% 38/94 • Number of events 56 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	18.6% 19/102 • Number of events 19 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Pyrexia	12.0% 12/100 • Number of events 13 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	6.7% 7/104 • Number of events 8 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	8.0% 8/100 • Number of events 8 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.1% 2/94 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.9% 3/102 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site induration	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	4.8% 5/104 • Number of events 5 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	4.3% 4/94 • Number of events 4 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site erythema	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.9% 3/104 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	4.0% 4/100 • Number of events 4 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site swelling	3.0% 3/100 • Number of events 4 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.9% 2/104 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Vaccination site erythema	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	3.0% 3/100 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Vaccination site swelling	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.0% 2/102 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Vaccination site induration	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site hypersensitivity	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
General disorders Injection site discolouration	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Respiratory tract infection viral	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Sinusitis	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Oral herpes	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Acute sinusitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Infections and infestations Nasopharyngitis	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	2.9% 3/104 • Number of events 3 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Arthropod sting	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Injury, poisoning and procedural complications Vaccination complication	2.0% 2/100 • Number of events 2 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Headache	60.0% 60/100 • Number of events 92 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	54.8% 57/104 • Number of events 82 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	54.0% 54/100 • Number of events 75 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	55.3% 52/94 • Number of events 75 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	35.3% 36/102 • Number of events 36 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Dizziness	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Nervous system disorders Paraesthesia	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.96% 1/104 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.1% 1/94 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Ear and labyrinth disorders Vertigo	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Immune system disorders Food allergy	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.98% 1/102 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Investigations Weight decreased	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Investigations Weight increased	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/100 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/104 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	1.0% 1/100 • Number of events 1 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/94 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).	0.00% 0/102 • Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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.
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