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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: Men ACWY CRM; Biological: 4CMenB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560313

2007-001563-29

V72P4

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

4CMenB

Experimental group

Treatment:

Biological: 4CMenB

MenACWY CRM

Experimental group

Treatment:

Biological: Men ACWY CRM