Meningitis, Meningococcal, Serogroup B
Conditions
Brief summary
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
Interventions
One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals of 18 through 50 years of age on the day of informed consent; 2. Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry; 3. Individuals who could comply with study procedures including follow-up; 4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.
Exclusion criteria
1. Progressive, unstable or uncontrolled clinical conditions; 2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study; 3. Abnormal function of the immune system; 4. Chronic clinical significant conditions; 4\. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67) | Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. | Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2. | The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test. |
Countries
Poland
Participant flow
Recruitment details
Subjects will be enrolled at one site in Poland from December 2014 to February 2015.
Pre-assignment details
All enrolled subjects will be included in the trial and assigned to the same treatment group.
Participants by arm
| Arm | Count |
|---|---|
| rMenB+OMV NZ Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | rMenB+OMV NZ |
|---|---|
| Age, Continuous | 27.2 YEARS STANDARD_DEVIATION 6.932 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 1 / 55 |
Outcome results
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
Time frame: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)
Population: Analysis were evaluated on the Unsolicited Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Any Serious Adverse Events (SAEs) (vaccination 1) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Any Serious Adverse Events (SAEs) (vaccination 2) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | At least possibly related SAEs (vaccination 1) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | At least possibly related SAEs (vaccination 2) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | AEs leading to premature withdrawal (vaccination1) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | AEs leading to premature withdrawal (vaccination2) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Medically attended AEs (vaccination 1) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Medically attended AEs (vaccination 2) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | AESIs (AEs of Special Interest) (vaccination 1) | 0 Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | AESIs (AEs of Special Interest) (vaccination 2) | 0 Subjects |
Other Pre-specified
Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.
The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.
Time frame: Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.
Population: The analysis was performed on the all enrolled dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. | Study Day 1 Blood Sample | 55 Participants |
| rMenB+OMV NZ | Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. | Postvaccination 2 Blood Sample | 50 Participants |