Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis

Conditions
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Meningitis, Meningococcal, Serogroup B

Intervention / Treatment
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* Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals of 18 through 50 years of age on the day of informed consent; 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; Individuals who could comply with study procedures including follow-up; Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method. Exclusion Criteria: Progressive, unstable or uncontrolled clinical conditions; Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study; Abnormal function of the immune system; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rMenB+OMV NZ<br>Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule | Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine<br>* One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.<br>* Other names: rMenB+OMV NZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination. | From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67) |