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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Sche

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 Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents [ Time Frame: 1 month after completion of immunization schedule ]

Original Primary Outcome: Safety, tolerability and immunogenicity of the two vaccines in healthy adolescents, 1 month after completion of immunization schedule.

Current Secondary Outcome: Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents [ Time Frame: 6 months after completion of immunization schedule ]

Original Secondary Outcome: Safety, tolerability and immunogenicity of the two vaccines in healthy adolescents, 6 months after completion of immunization schedule.

Information By: Novartis

Dates:
Date Received: February 27, 2006
Date Started: February 2006
Date Completion:
Last Updated: November 30, 2016
Last Verified: January 2012