Trial Outcomes & Findings for A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive. (NCT NCT01911221)
NCT ID: NCT01911221
Last Updated: 2017-06-08
Results Overview
The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Day1 and Day 91
Results posted on
2017-06-08
Participant Flow
Subjects were recruited from single study center in Germany.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
rMenB+OMV NZ
Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
Baseline characteristics by cohort
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
|
|---|---|
|
Age, Continuous
|
38.5 year
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
FEMALE
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
MALE
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day1 and Day 91Population: Analysis was done on Full Analysis Set
The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
5/99 Prevaccination (Day 1)
|
2.27 Titers
Interval 1.34 to 3.85
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
H44/76 Prevaccination (Day 1)
|
1.18 Titers
Interval 0.92 to 1.52
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
Post 2nd vaccination (Day 91)
|
53 Titers
Interval 34.0 to 84.0
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
After 2nd vaccination (Day 91)(N=12)
|
143 Titers
Interval 57.0 to 356.0
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
NZ98/254 Prevaccination (Day 1)
|
1.09 Titers
Interval 0.91 to 1.31
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
Post 2nd vaccination (Day 91)(N=12)
|
15 Titers
Interval 5.41 to 43.0
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
M10713 Prevaccination (Day 1)
|
21 Titers
Interval 12.0 to 39.0
|
|
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
Post second vaccination (Day 91)(N=12)
|
56 Titers
Interval 31.0 to 99.0
|
PRIMARY outcome
Timeframe: Day1 and Day 91Population: The analysis was done on the Full Analysis Set.
The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
H44/76 (Day 91/Day 1)
|
45 ratio
Interval 29.0 to 70.0
|
|
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
5/99 (Day 91/Day 1)(N=12)
|
59 ratio
Interval 21.0 to 166.0
|
|
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
NZ98/254 (Day 91/Day 1)(N=12)
|
14 ratio
Interval 5.17 to 37.0
|
|
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
M10713 (Day 91/Day 1)(N=12)
|
2.99 ratio
Interval 1.43 to 6.27
|
PRIMARY outcome
Timeframe: Day1 and Day91Population: Analysis was done on Full Analysis Set.
The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
5/99 Prevaccination (Day 1)
|
31 Percentages of subjects
Interval 9.0 to 61.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
M10713 Prevaccination (Day 1)
|
92 Percentages of subjects
Interval 64.0 to 100.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
H44/76 Prevaccination (Day 1)
|
0 Percentages of subjects
Interval 0.0 to 25.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post 2nd vaccination (Day 91)
|
100 Percentages of subjects
Interval 75.0 to 100.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
After 2nd vaccination (Day 91)(N=12)
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
NZ98/254 Prevaccination (Day 1)
|
0 Percentages of subjects
Interval 0.0 to 25.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post 2nd vaccination (Day 91)(N=12)
|
75 Percentages of subjects
Interval 43.0 to 95.0
|
|
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post second vaccination (Day 91)(N=12)
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
PRIMARY outcome
Timeframe: Day1 and Day91Population: Analysis was done on Full Analysis Set.
The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
H44/76 Prevaccination (Day 1)
|
0 Percentage of Subjects
Interval 0.0 to 25.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post 2nd vaccination (Day 91)
|
100 Percentage of Subjects
Interval 75.0 to 100.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
5/99 Prevaccination (Day 1)
|
8 Percentage of Subjects
Interval 0.0 to 36.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
After 2nd vaccination (Day 91)(N=12)
|
92 Percentage of Subjects
Interval 62.0 to 100.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
NZ98/254 Prevaccination (Day 1)
|
0 Percentage of Subjects
Interval 0.0 to 25.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post 2nd vaccination (Day 91)(N=12)
|
75 Percentage of Subjects
Interval 43.0 to 95.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
M10713 Prevaccination (Day 1)
|
85 Percentage of Subjects
Interval 55.0 to 98.0
|
|
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
Post second vaccination (Day 91)(N=12)
|
92 Percentage of Subjects
Interval 62.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 91Population: Analysis was done on Full Analysis Set.
The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.
H44/76
|
100 Percentage of subjects
Interval 75.0 to 100.0
|
|
Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.
5/99 (N=12)
|
92 Percentage of subjects
Interval 62.0 to 100.0
|
|
Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.
NZ98/254 (N=12)
|
75 Percentage of subjects
Interval 43.0 to 95.0
|
|
Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.
M10713 (N=12)
|
33 Percentage of subjects
Interval 10.0 to 65.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 91Population: Analysis was done on Full Analysis Set.
The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule
Prevaccination (Day 1)
|
22 U/mL
Interval 18.0 to 28.0
|
|
Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule
Post second vaccination (Day 91)
|
1200 U/mL
Interval 537.0 to 2680.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 91Population: Analysis was done on Full Analysis Set.
The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
|
54 Ratio
Interval 24.0 to 120.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 91Population: Analysis was done on Full Analysis Set.
The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
|
85 Percentage of Subjects
Interval 55.0 to 98.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 postvaccination.Population: Analysis was done on Solicited Safety Set.
The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Any local
|
13 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Injection site erythema
|
0 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Injection site swelling
|
0 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Injection site induration
|
1 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Injection site pain
|
13 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Any Systemic
|
9 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Nausea
|
2 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Myalgia
|
3 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Arthralgia
|
3 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Fatigue
|
5 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Headache
|
8 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Fever (≥38°C)
|
1 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Prophylactic use of antipyretics/analgesics
|
0 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
Therapeutic use of antipyretics/analgesics
|
4 Number of Subjects
|
PRIMARY outcome
Timeframe: Day 1 through Day 91 postvaccination.Population: Analysis was done on Unsolicited Safety Set.
Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
At least possibly related unsolicited AEs
|
7 Number of subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
Any unsolicited AEs
|
8 Number of subjects
|
PRIMARY outcome
Timeframe: Day 1 through Day 91 postvaccination.Population: Analysis was done on Unsolicited Safety Set.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
Outcome measures
| Measure |
rMenB+OMV NZ
n=13 Participants
Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
AEs leading to death
|
0 Number of subjects
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
AEs leading to study withdrawal
|
0 Number of subjects
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
Medically attended AEs
|
2 Number of subjects
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
Any SAEs
|
0 Number of subjects
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
At least possibly related SAEs
|
0 Number of subjects
|
Adverse Events
rMenB+OMVNZ
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rMenB+OMVNZ
n=13 participants at risk
Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
|
|---|---|
|
Gastrointestinal disorders
NAUSEA
|
15.4%
2/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
CHILLS
|
7.7%
1/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
FATIGUE
|
38.5%
5/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
76.9%
10/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
INJECTION SITE INDURATION
|
38.5%
5/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
INJECTION SITE PAIN
|
100.0%
13/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
INJECTION SITE SWELLING
|
38.5%
5/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
General disorders
PYREXIA
|
7.7%
1/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.7%
1/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
15.4%
2/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
23.1%
3/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
23.1%
3/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
|
Nervous system disorders
HEADACHE
|
61.5%
8/13 • Day 1 through Day 91 postvaccination.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60