Trial Outcomes & Findings for Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years. (NCT NCT01973218)
NCT ID: NCT01973218
Last Updated: 2015-10-30
Results Overview
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
Day 1 and Day 61
Results posted on
2015-10-30
Participant Flow
Subjects were recruited from 7 study sites in Korea.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
rMENB
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
88
|
|
Overall Study
COMPLETED
|
174
|
88
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
rMENB
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Baseline characteristics by cohort
| Measure |
rMENB
n=176 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 61Population: Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
H44/76 strain (Day 1)
|
26 percentage of subjects
Interval 20.0 to 33.0
|
24 percentage of subjects
Interval 15.0 to 34.0
|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
H44/76 strain (Day 61)
|
98 percentage of subjects
Interval 97.0 to 99.0
|
27 percentage of subjects
Interval 18.0 to 38.0
|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
5/99 strain (Day 1)
|
12 percentage of subjects
Interval 8.0 to 18.0
|
10 percentage of subjects
Interval 5.0 to 19.0
|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
5/99 strain (Day 61)
|
97 percentage of subjects
Interval 93.0 to 99.0
|
16 percentage of subjects
Interval 9.0 to 25.0
|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
NZ98/254 strain (Day 1)
|
16 percentage of subjects
Interval 10.0 to 22.0
|
15 percentage of subjects
Interval 8.0 to 24.0
|
|
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
NZ98/254 strain (Day 61)
|
97 percentage of subjects
Interval 93.0 to 99.0
|
17 percentage of subjects
Interval 10.0 to 27.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 61Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
H44/76 strain (Day 1)
|
2.31 Titers
Interval 1.94 to 2.74
|
2.18 Titers
Interval 1.72 to 2.77
|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
H44/76 strain (Day 61)
|
91 Titers
Interval 74.0 to 112.0
|
2.56 Titers
Interval 1.91 to 3.43
|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
5/99 strain (Day 1)
|
1.5 Titers
Interval 1.31 to 1.72
|
1.37 Titers
Interval 1.16 to 1.61
|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
5/99 strain (Day 61)
|
351 Titers
Interval 284.0 to 432.0
|
1.84 Titers
Interval 1.34 to 2.52
|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
NZ98/254 strain (Day 1)
|
1.71 Titers
Interval 1.45 to 2.02
|
1.59 Titers
Interval 1.27 to 1.99
|
|
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
NZ98/254 strain (Day 61)
|
32 Titers
Interval 26.0 to 40.0
|
1.77 Titers
Interval 1.35 to 2.32
|
SECONDARY outcome
Timeframe: Day 61/ Day 1Population: Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints
The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
H44/76 strain
|
40 Ratio
Interval 32.0 to 49.0
|
1.18 Ratio
Interval 0.92 to 1.51
|
|
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
5/99 strain
|
234 Ratio
Interval 181.0 to 301.0
|
1.34 Ratio
Interval 1.0 to 1.81
|
|
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
NZ98/254 strain
|
19 Ratio
Interval 15.0 to 23.0
|
1.11 Ratio
Interval 0.92 to 1.35
|
SECONDARY outcome
Timeframe: Day 61Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
H44/76 strain
|
93 percentage of subjects
Interval 88.0 to 96.0
|
8 percentage of subjects
Interval 3.0 to 16.0
|
|
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
5/99 strain
|
97 percentage of subjects
Interval 93.0 to 99.0
|
6 percentage of subjects
Interval 2.0 to 13.0
|
|
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
NZ98/254 strain
|
83 percentage of subjects
Interval 76.0 to 88.0
|
6 percentage of subjects
Interval 2.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 61Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints
The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.
Outcome measures
| Measure |
rMenb
n=172 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
Day1
|
23 IU/mL
Interval 22.0 to 24.0
|
26 IU/mL
Interval 23.0 to 29.0
|
|
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
Day61
|
1208 IU/mL
Interval 1025.0 to 1423.0
|
27 IU/mL
Interval 23.0 to 32.0
|
SECONDARY outcome
Timeframe: Day 61/Day 1Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.
Outcome measures
| Measure |
rMenb
n=172 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
|
52 Ratio
Interval 44.0 to 62.0
|
1.05 Ratio
Interval 0.9 to 1.22
|
SECONDARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.
The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Any Local (1st vacc; N=174, 87)
|
160 Number of subjects
|
22 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site pain (1st vacc; N=174,87)
|
158 Number of subjects
|
18 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site erythema I (1st vacc; N=174,87)
|
62 Number of subjects
|
5 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site erythema II (1st vacc; N=174,87)
|
14 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site swelling I (1st vacc; N=174,87)
|
57 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site swelling II (1st vacc; N=174,87)
|
19 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site induration I (1st vacc; N=174,87)
|
55 Number of subjects
|
3 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site induration II (1st vacc; N=174,87)
|
29 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Any Local (2nd vacc; N=173,88)
|
145 Number of subjects
|
36 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site pain (2nd vacc; N=173,88)
|
142 Number of subjects
|
33 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site erythema I (2nd vacc; N=173,88)
|
49 Number of subjects
|
17 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site erythema II (2nd vacc; N=173,88)
|
11 Number of subjects
|
7 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site swelling I (2nd vacc; N=173,88)
|
47 Number of subjects
|
16 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site swelling II (2nd vacc; N=173,88)
|
16 Number of subjects
|
3 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site induration I (2nd vacc; N=172,88)
|
54 Number of subjects
|
17 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Injec site induration II (2nd vacc; N=172,88)
|
26 Number of subjects
|
7 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Any Systemic (1st vacc; N=174,87)
|
89 Number of subjects
|
31 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Loss of appetite (1st vacc; N=174,87)
|
15 Number of subjects
|
8 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Nausea (1st vacc; N=174,88)
|
20 Number of subjects
|
7 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Malaise (1st vacc; N=174,87)
|
51 Number of subjects
|
13 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Myalgia (1st vacc; N=174,87)
|
45 Number of subjects
|
10 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Arthralgia (1st vacc; N=174,87)
|
14 Number of subjects
|
4 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Headache (1st vacc; N=174,87)
|
42 Number of subjects
|
19 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Body Temperature (≥38°C) (1st vacc; N=174,87)
|
6 Number of subjects
|
1 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Prevention of pain/fever (1st vacc;N=174,87)
|
1 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Treatment of pain/fever (1st vacc;N=174,87)
|
11 Number of subjects
|
1 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Medically attended fever (1st vacc;N=174,86)
|
1 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Any Systemic (2nd vacc; N=173,88)
|
74 Number of subjects
|
21 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Loss of appetite (2nd vacc; N=173,88)
|
21 Number of subjects
|
4 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Nausea (2nd vacc; N=173,88)
|
15 Number of subjects
|
5 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Malaise (2nd vacc; N=173,88)
|
47 Number of subjects
|
10 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Myalgia (2nd vacc; N=173,88)
|
29 Number of subjects
|
9 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Arthralgia (2nd vacc; N=173,88)
|
15 Number of subjects
|
7 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Headache (2nd vacc; N=173,88)
|
50 Number of subjects
|
16 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Body Temperature (≥38°C) (2nd vacc; N=173,88)
|
9 Number of subjects
|
1 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Prevention of pain/fever (2nd vacc;N=173,88)
|
1 Number of subjects
|
0 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Treatment of pain/fever (2nd vacc;N=173,88)
|
12 Number of subjects
|
1 Number of subjects
|
|
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Medically attended fever (2nd vacc;N=171,88)
|
2 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: Day 1 through Day 61Population: Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.
The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Outcome measures
| Measure |
rMenb
n=174 Participants
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 Participants
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
|---|---|---|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Any AE
|
45 number of subjects
|
10 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Possibly or Probably Related AES
|
30 number of subjects
|
3 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
SAEs
|
2 number of subjects
|
0 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
At least possibly related SAEs
|
0 number of subjects
|
0 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Deaths
|
0 number of subjects
|
0 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Medically attended AEs
|
45 number of subjects
|
20 number of subjects
|
|
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
AEs resulting in premature withdrawal
|
1 number of subjects
|
0 number of subjects
|
Adverse Events
rMENB
Serious events: 2 serious events
Other events: 167 other events
Deaths: 0 deaths
Placebo/MenACWY
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Total
Serious events: 2 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rMENB
n=175 participants at risk；n=174 participants at risk
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 participants at risk
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
Total
n=263 participants at risk；n=262 participants at risk
Total of subjects
|
|---|---|---|---|
|
Infections and infestations
GASTROENTERITIS
|
0.57%
1/174 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
0.00%
0/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
0.38%
1/262 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Reproductive system and breast disorders
PAROVARIAN CYST
|
0.57%
1/174 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
0.00%
0/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
0.38%
1/262 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
Other adverse events
| Measure |
rMENB
n=175 participants at risk；n=174 participants at risk
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
|
Placebo/MenACWY
n=88 participants at risk
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
|
Total
n=263 participants at risk；n=262 participants at risk
Total of subjects
|
|---|---|---|---|
|
General disorders
INJECTION SITE INDURATION
|
24.6%
43/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
8.0%
7/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
19.0%
50/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Gastrointestinal disorders
NAUSEA
|
17.1%
30/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
11.4%
10/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
15.2%
40/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
General disorders
INJECTION SITE ERYTHEMA
|
14.3%
25/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
9.1%
8/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
12.5%
33/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
General disorders
INJECTION SITE PAIN
|
94.9%
166/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
54.5%
48/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
81.4%
214/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
General disorders
INJECTION SITE SWELLING
|
17.7%
31/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
4.5%
4/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
13.3%
35/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
General disorders
MALAISE
|
44.0%
77/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
19.3%
17/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
35.7%
94/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
General disorders
PYREXIA
|
9.1%
16/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
2.3%
2/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
6.8%
18/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.1%
16/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
15.9%
14/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
11.4%
30/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Psychiatric disorders
EATING DISORDERS
|
16.6%
29/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
12.5%
11/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
15.2%
40/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
14.9%
26/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
12.5%
11/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
14.1%
37/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
34.3%
60/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
17.0%
15/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
28.5%
75/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
|
Nervous system disorders
HEADACHE
|
44.6%
78/175 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
35.2%
31/88 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
41.4%
109/263 • Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER