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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-11-30

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.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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4CMenB

Group Type EXPERIMENTAL

4CMenB

Intervention Type BIOLOGICAL

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.

MenACWY CRM

Group Type EXPERIMENTAL

Men ACWY CRM

Intervention Type BIOLOGICAL

A single dose of a 0.5 mL injectable solution

Interventions

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Men ACWY CRM

A single dose of a 0.5 mL injectable solution

Intervention Type BIOLOGICAL

4CMenB

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.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes