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.

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

Official Title
-----------------
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.

Conditions
-----------------
Prevention of the Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: rMenB+OMV NZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); In good health as determined by medical history, physical examination and clinical judgment of the investigator; Who are or might be routinely exposed to cultures of N. meningitidis serogroup B. Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria. Exclusion Criteria: Pregnancy or nursing (breastfeeding) mothers; Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry; Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria; History of any serogroup B meningococcal vaccine administration; Previous known or suspected disease caused by N. meningitidis; History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine; Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): Receipt of any chronic immunosuppressive therapy Receipt of any chronic immunostimulants Immune deficiency disorder, or known HIV infection Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study; History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; Any significant chronic infection; Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time; Family members and household members of research staff; Participation in another clinical trial within the last 30 days or planned for during study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rMenB+OMV NZ<br>A single 0.5mL dose of the study vaccine will be administered intramuscularly in the deltoid muscle. | Biological: rMenB+OMV NZ<br>* Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | 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. | Day1 and Day 91 | 
| Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | 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. | Day1 and Day 91 | 
| Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | 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. | Day1 and Day91 | 
| Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | 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. | Day1 and Day91 | 
| 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. | 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. | Day 91 | 
| Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | 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. | Day 1 and Day 91 | 
| Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | 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. | Day 1 and Day 91 | 
| Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | 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. | Day 1 and Day 91 | 
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | 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. | Day 1 through Day 7 postvaccination. | 
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | 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. | Day 1 through Day 91 postvaccination. | 
| Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | 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. | Day 1 through Day 91 postvaccination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, Meningococcal disease,