Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.

Official Title
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A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age

Conditions
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Meningococcal Disease

Intervention / Treatment
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* Biological: serogroup B meningococcal vaccine
* Biological: serogroup B meningococcal vaccine
* Biological: serogroup B meningococcal vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adolescents between and including 11-18 years of age, who provide written informed consent. Exclusion Criteria: Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: rMenB<br> | Biological: serogroup B meningococcal vaccine<br>* 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.<br>|
| Experimental: Arm 2: rMenB + OMV<br> | Biological: serogroup B meningococcal vaccine<br>* 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.<br>|
| Placebo Comparator: Arm 3: Placebo<br> | Biological: serogroup B meningococcal vaccine<br>* 0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents |  | 1 month after completion of immunization schedule | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents |  | 6 months after completion of immunization schedule | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal Disease; Meningococcal Meningitis; Vaccine