Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

Phase 1

Completed

• Conditions: Meningitis, Meningococcal

• Registration Number: NCT00297687
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-02-28
• Study Start: 2006-03
• Study Completion: 2007-03
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Healthy 18-25 year olds

Exclusion Criteria

• Prior history of vaccination with any meningococcal vaccine
• Prior history of any invasive meningococcal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local & systemic safety throughout the trial

Secondary Outcome Measures

Name	Time	Method
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3