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

Phase 2

Completed

• Conditions: Meningococcal Disease
• Interventions: Biological: serogroup B meningococcal vaccine

• Registration Number: NCT00297817
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-03-01
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: rMenB + OMV	serogroup B meningococcal vaccine	-
Arm 1: rMenB	serogroup B meningococcal vaccine	-
Arm 3: Placebo	serogroup B meningococcal vaccine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents	6 months after completion of immunization schedule