Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

Study Overview
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Brief Summary
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This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Official Title
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A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

Conditions
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Meningococcal Disease

Intervention / Treatment
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* Biological: Men ACWY CRM
* Biological: 4CMenB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults,18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures Exclusion Criteria: Previous ascertained or suspected disease caused by N. meningitidis; Pregnancy or breastfeeding; History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; Any present or suspected serious acute or chronic disease Known or suspected autoimmune disease or impairment /alteration of immune function

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4CMenB<br> | Biological: 4CMenB<br>* All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.<br>|
| Experimental: MenACWY CRM<br> | Biological: Men ACWY CRM<br>* A single dose of a 0.5 mL injectable solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. | Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains. | One month after vaccinations | 
| Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination. | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: prior to the first vaccination 30 days following the first, second, prior to the third and 30 days after the third vaccination | One month after vaccinations | 
| Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination. | Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains. | One month after vaccinations | 
| Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination | Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: prior to the first vaccination 30 days following the first, second, prior to the third and 30 days after the third vaccination | One month after vaccinations | 
| Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination. | The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7. | One month after vaccinations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal disease, prevention, vaccination