Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants (NCT NCT00433914)

Last Updated: 2015-03-06

Results Overview

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline and one month after second and third vaccination

Results posted on

2015-03-06

Participant Flow

Subjects were enrolled at one study center in the United Kingdom (UK).

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	rMenB 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	27
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	rMenB 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Study Withdrawal by Subject	0	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rMenB n=30 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=30 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	Total n=60 Participants Total of all reporting groups
Age, Continuous	7.0 Months STANDARD_DEVIATION 0.8 • n=93 Participants	7.1 Months STANDARD_DEVIATION 0.7 • n=4 Participants	7.1 Months STANDARD_DEVIATION 0.7 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	18 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	12 Participants n=4 Participants	28 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and one month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=24 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Baseline	8 Percentage of subjects Interval 1.0 to 26.0	29 Percentage of subjects Interval 13.0 to 51.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Baseline	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 14.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-3rd Vaccination (N=24,24)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Baseline	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 14.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	4 Percentage of subjects Interval 0.0 to 21.0	95 Percentage of subjects Interval 77.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-3rd Vaccination (N=22,24)	9 Percentage of subjects Interval 1.0 to 29.0	96 Percentage of subjects Interval 79.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UK P1.7-2,4 - Baseline (N=24,21)	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 16.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)	0 Percentage of subjects Interval 0.0 to 15.0	100 Percentage of subjects Interval 82.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)	5 Percentage of subjects Interval 0.0 to 24.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Baseline (N=24,21)	0 Percentage of subjects Interval 0.0 to 14.0	10 Percentage of subjects Interval 1.0 to 30.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-2nd Vaccination (N=22,21)	23 Percentage of subjects Interval 8.0 to 45.0	67 Percentage of subjects Interval 43.0 to 85.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-3rd Vaccination (N=22,22)	27 Percentage of subjects Interval 11.0 to 50.0	73 Percentage of subjects Interval 50.0 to 89.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Baseline (N=12,11)	0 Percentage of subjects Interval 0.0 to 26.0	0 Percentage of subjects Interval 0.0 to 28.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-2nd Vaccination (N=11,14)	0 Percentage of subjects Interval 0.0 to 28.0	7 Percentage of subjects Interval 0.0 to 34.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-3rd Vaccination (N=12,11)	0 Percentage of subjects Interval 0.0 to 26.0	18 Percentage of subjects Interval 2.0 to 52.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Baseline (N=22,17)	9 Percentage of subjects Interval 1.0 to 29.0	12 Percentage of subjects Interval 1.0 to 36.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-2nd Vaccination (N=19,16)	95 Percentage of subjects Interval 74.0 to 100.0	88 Percentage of subjects Interval 62.0 to 98.0
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-3rd Vaccination (N=17,19)	88 Percentage of subjects Interval 64.0 to 99.0	95 Percentage of subjects Interval 74.0 to 100.0

PRIMARY outcome

Timeframe: Baseline and one month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set.

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=24 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Baseline	0 Percentage of subjects Interval 0.0 to 14.0	4 Percentage of subjects Interval 0.0 to 21.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	96 Percentage of subjects Interval 80.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Baseline	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 14.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-3rd Vaccination (N=24,24)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Baseline	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 14.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	0 Percentage of subjects Interval 0.0 to 14.0	91 Percentage of subjects Interval 71.0 to 99.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-3rd Vaccination (N=22,24)	5 Percentage of subjects Interval 0.0 to 23.0	96 Percentage of subjects Interval 79.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UK P1.7-2,4 - Baseline (N=24,21)	0 Percentage of subjects Interval 0.0 to 14.0	0 Percentage of subjects Interval 0.0 to 16.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)	0 Percentage of subjects Interval 0.0 to 15.0	84 Percentage of subjects Interval 60.0 to 97.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)	0 Percentage of subjects Interval 0.0 to 16.0	95 Percentage of subjects Interval 77.0 to 100.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Baseline (N=24,21)	0 Percentage of subjects Interval 0.0 to 14.0	10 Percentage of subjects Interval 1.0 to 30.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-2nd Vaccination (N=22,21)	9 Percentage of subjects Interval 1.0 to 29.0	33 Percentage of subjects Interval 15.0 to 57.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-3rd Vaccination (N=22,22)	14 Percentage of subjects Interval 3.0 to 35.0	45 Percentage of subjects Interval 24.0 to 68.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Baseline (N=12,11)	0 Percentage of subjects Interval 0.0 to 26.0	0 Percentage of subjects Interval 0.0 to 28.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-2nd Vaccination (N=11,14)	0 Percentage of subjects Interval 0.0 to 28.0	0 Percentage of subjects Interval 0.0 to 23.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-3rd Vaccination (N=12,11)	0 Percentage of subjects Interval 0.0 to 26.0	0 Percentage of subjects Interval 0.0 to 28.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Baseline (N=22,17)	0 Percentage of subjects Interval 0.0 to 15.0	0 Percentage of subjects Interval 0.0 to 20.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-2nd Vaccination (N=19,16)	74 Percentage of subjects Interval 49.0 to 91.0	69 Percentage of subjects Interval 41.0 to 89.0
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-3rd Vaccination (N=17,19)	71 Percentage of subjects Interval 44.0 to 90.0	84 Percentage of subjects Interval 60.0 to 97.0

SECONDARY outcome

Timeframe: One month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set.

Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=24 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	96 Percentage of subjects Interval 80.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-3rd Vaccination	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	0 Percentage of subjects Interval 0.0 to 14.0	91 Percentage of subjects Interval 71.0 to 99.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-3rd Vaccination (N=22,24)	5 Percentage of subjects Interval 0.0 to 23.0	96 Percentage of subjects Interval 79.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17)	0 Percentage of subjects Interval 0.0 to 15.0	88 Percentage of subjects Interval 64.0 to 99.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20)	0 Percentage of subjects Interval 0.0 to 17.0	95 Percentage of subjects Interval 75.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-2nd Vaccination (N=21,18)	10 Percentage of subjects Interval 1.0 to 30.0	22 Percentage of subjects Interval 6.0 to 48.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-3rd Vaccination (N=21,19)	14 Percentage of subjects Interval 3.0 to 36.0	32 Percentage of subjects Interval 13.0 to 57.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-2nd Vaccination (N=5,7)	0 Percentage of subjects Interval 0.0 to 52.0	0 Percentage of subjects Interval 0.0 to 41.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-3rd Vaccination (N=7,6)	0 Percentage of subjects Interval 0.0 to 41.0	0 Percentage of subjects Interval 0.0 to 46.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-2nd Vaccination (N=17,14)	76 Percentage of subjects Interval 50.0 to 93.0	64 Percentage of subjects Interval 35.0 to 87.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-3rd Vaccination (N=15,15)	80 Percentage of subjects Interval 52.0 to 96.0	80 Percentage of subjects Interval 52.0 to 96.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ 287-953proteinantigen-Post-2ndVaccination(N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ 287-953proteinantigen-Post-3rdVaccination(N=24,25)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and one month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set.

The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=24 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-3rd Vaccination (N=12,11)	1.06 Geometric mean titers Interval 0.82 to 1.36	1.46 Geometric mean titers Interval 1.12 to 1.9
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Baseline	1.16 Geometric mean titers Interval 0.89 to 1.52	1.70 Geometric mean titers Interval 1.29 to 2.24
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-2nd Vaccination (N=25,23)	94 Geometric mean titers Interval 66.0 to 134.0	250 Geometric mean titers Interval 173.0 to 361.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	109 Geometric mean titers Interval 79.0 to 153.0	189 Geometric mean titers Interval 136.0 to 263.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Baseline	1.00 Geometric mean titers Interval 0.94 to 1.07	1.05 Geometric mean titers Interval 0.98 to 1.12
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-2nd Vaccination (N=25,23)	710 Geometric mean titers Interval 532.0 to 947.0	534 Geometric mean titers Interval 395.0 to 721.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain 5/99 - Post-3rd Vaccination (N=24,24)	1202 Geometric mean titers Interval 929.0 to 1555.0	906 Geometric mean titers Interval 700.0 to 1172.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Baseline	1.00 Geometric mean titers Interval 1.0 to 1.0	1.00 Geometric mean titers Interval 1.0 to 1.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	1.06 Geometric mean titers Interval 0.82 to 1.38	27 Geometric mean titers Interval 21.0 to 36.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain NZ98/254 - Post-3rd Vaccination (N=22,24)	1.21 Geometric mean titers Interval 0.86 to 1.72	44 Geometric mean titers Interval 32.0 to 62.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UK P1.7-2,4 - Baseline (N=24,21)	1.00 Geometric mean titers Interval 1.0 to 1.0	1.00 Geometric mean titers Interval 1.0 to 1.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)	1.00 Geometric mean titers Interval 0.75 to 1.34	17 Geometric mean titers Interval 12.0 to 24.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)	1.07 Geometric mean titers Interval 0.72 to 1.58	34 Geometric mean titers Interval 23.0 to 50.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Baseline (N=24,21)	1.12 Geometric mean titers Interval 0.81 to 1.56	1.49 Geometric mean titers Interval 1.05 to 2.11
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-2nd Vaccination (N=22,21)	1.82 Geometric mean titers Interval 1.14 to 2.9	4.56 Geometric mean titers Interval 2.83 to 7.35
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB101 - Post-3rd Vaccination (N=22,22)	2.20 Geometric mean titers Interval 1.14 to 4.23	9.36 Geometric mean titers Interval 4.87 to 18.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Baseline (N=12,11)	1.00 Geometric mean titers Interval 1.0 to 1.0	1.00 Geometric mean titers Interval 1.0 to 1.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB355 - Post-2nd Vaccination (N=11,14)	1.00 Geometric mean titers Interval 0.83 to 1.21	1.16 Geometric mean titers Interval 0.98 to 1.37
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Baseline (N=22,17)	1.46 Geometric mean titers Interval 1.19 to 1.79	1.50 Geometric mean titers Interval 1.19 to 1.9
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-2nd Vaccination (N=19,16)	11 Geometric mean titers Interval 6.39 to 19.0	12 Geometric mean titers Interval 6.75 to 23.0
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Strain GB364 - Post-3rd Vaccination (N=17,19)	12 Geometric mean titers Interval 6.17 to 22.0	21 Geometric mean titers Interval 11.0 to 37.0

SECONDARY outcome

Timeframe: Baseline and one month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set.

The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Antigen 287-953 - Baseline	24 µg/mL Interval 21.0 to 28.0	21 µg/mL Interval 18.0 to 24.0
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Antigen 287-953 - Post-2nd Vaccination (N=25,23)	1759 µg/mL Interval 1331.0 to 2324.0	2912 µg/mL Interval 2178.0 to 3894.0
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Antigen 287-953 - Post-3rd Vaccination (N=24,25)	2298 µg/mL Interval 1778.0 to 2970.0	3521 µg/mL Interval 2739.0 to 4527.0

SECONDARY outcome

Timeframe: One month after second and third vaccination

Population: Analysis was performed on the per protocol (PP) population set.

Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Outcome measures

Outcome measures
Measure	rMenB n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=25 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Antigen 287-953 - Post-2nd Vaccination (N=25,23)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 85.0 to 100.0
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ Antigen 287-953 - Post-3rd Vaccination (N=24,25)	100 Percentage of subjects Interval 86.0 to 100.0	100 Percentage of subjects Interval 86.0 to 100.0

SECONDARY outcome

Timeframe: Day 1 through day 7 after each vaccination

Population: Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.

Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).

Outcome measures

Outcome measures
Measure	rMenB n=30 Participants 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=30 Participants 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Local reactions	29 Number of subjects	29 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Tenderness - Vaccination 1	4 Number of subjects	9 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Tenderness - Vaccination 2 (N=30,28)	5 Number of subjects	11 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Tenderness - Vaccination 3 (N=30,27)	12 Number of subjects	10 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Erythema - Vaccination 1	26 Number of subjects	26 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Erythema - Vaccination 2 (N=30,28)	22 Number of subjects	25 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Erythema - Vaccination 3 (N=30,27)	24 Number of subjects	26 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Induration - Vaccination 1	15 Number of subjects	18 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Induration - Vaccination 2 (N=30,28)	12 Number of subjects	16 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Induration - Vaccination 3 (N=30,27)	15 Number of subjects	18 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Swelling - Vaccination 1	4 Number of subjects	11 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Swelling - Vaccination 2 (N=30,28)	9 Number of subjects	10 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Swelling - Vaccination 3 (N=30,27)	11 Number of subjects	9 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Systemic reactions	22 Number of subjects	28 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Change in eating habits - Vaccination 1 (N=30,29)	6 Number of subjects	8 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Change in eating habits - Vaccination 2 (N=30,27)	1 Number of subjects	7 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Change in eating habits - Vaccination 3 (N=30,27)	8 Number of subjects	5 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Sleepiness - Vaccination 1	7 Number of subjects	11 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Sleepiness - Vaccination 2 (N=30,28)	7 Number of subjects	8 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Sleepiness - Vaccination 3 (N=30,27)	7 Number of subjects	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Vomiting - Vaccination 1	6 Number of subjects	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Vomiting - Vaccination 2 (N=30,28)	1 Number of subjects	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Vomiting - Vaccination 3 (N=30,27)	6 Number of subjects	2 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Diarrhea - Vaccination 1	2 Number of subjects	5 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Diarrhea - Vaccination 2 (N=30,28)	4 Number of subjects	1 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Diarrhea - Vaccination 3 (N=30,27)	5 Number of subjects	5 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Unusual crying - Vaccination 1	2 Number of subjects	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Unusual crying - Vaccination 2 (N=30,28)	2 Number of subjects	2 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Unusual crying - Vaccination 3 (N=30,27)	4 Number of subjects	7 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Irritability - Vaccination 1	14 Number of subjects	14 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Irritability - Vaccination 2 (N=30,28)	10 Number of subjects	17 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Irritability - Vaccination 3 (N=30,28)	13 Number of subjects	18 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Rash - Vaccination 1	3 Number of subjects	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Rash - Vaccination 2 (N=30,28)	5 Number of subjects	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Rash - Vaccination 3 (N=30,27)	5 Number of subjects	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Fever (≥38 °C) - Vaccination 1	1 Number of subjects	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Fever (≥38 °C) - Vaccination 2 (N=30,28)	2 Number of subjects	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Fever (≥38 °C) - Vaccination 3 (N=30,27)	4 Number of subjects	1 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Analg/Antipyr medications used - Vaccination 1	10 Number of subjects	18 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Analg/Antipyr medications used - Vaccination 2	12 Number of subjects	17 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ Analg/Antipyr medications used - Vaccination 3	15 Number of subjects	16 Number of subjects

Adverse Events

rMenB

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

rMenB+OMV

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rMenB n=30 participants at risk 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=30 participants at risk 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Infections and infestations Cellulitis	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Croup infectious	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Gastroenteritis	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Localised infection	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Nervous system disorders Febrile convulsion	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Respiratory, thoracic and mediastinal disorders Wheezing	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	rMenB n=30 participants at risk 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.	rMenB+OMV n=30 participants at risk 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	20.0% 6/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Nervous system disorders Somnolence	46.7% 14/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	53.3% 16/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Induration	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	13.3% 4/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Injection site erythema	93.3% 28/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	93.3% 28/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Injection site swelling	46.7% 14/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	56.7% 17/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Pyrexia	23.3% 7/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	20.0% 6/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Swelling	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	10.0% 3/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Crying	16.7% 5/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	33.3% 10/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Injection site pain	43.3% 13/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	60.0% 18/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders vaccination site erythema	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Psychiatric disorders Irritability	60.0% 18/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	83.3% 25/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Psychiatric disorders Eating disorder	43.3% 13/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	46.7% 14/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Gastrointestinal disorders Diarrhoea	53.3% 16/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	43.3% 13/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Gastrointestinal disorders Teething	36.7% 11/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	43.3% 13/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Gastrointestinal disorders Vomiting	53.3% 16/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	33.3% 10/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Skin and subcutaneous tissue disorders Eczema	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Skin and subcutaneous tissue disorders Erythema	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	13.3% 4/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Skin and subcutaneous tissue disorders Rash	26.7% 8/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	30.0% 9/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Conjunctivitis	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	16.7% 5/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Gastroenteritis	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	13.3% 4/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Lower respiratory tract infection	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	10.0% 3/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Nasopharyngitis	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	10.0% 3/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Otitis media	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Rhinitis	16.7% 5/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	10.0% 3/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Tonsilitis	3.3% 1/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Upper respiratory tract infection	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Varicella	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Viral rash	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	6.7% 2/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Infections and infestations Viral upper respiratory tract infection	13.3% 4/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	0.00% 0/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
General disorders Injection site induration	66.7% 20/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)	86.7% 26/30 • Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)