Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents - Tabular View

Tracking Information

First Received Date ^ICMJE

December 2, 2005

Last Updated Date

September 13, 2006

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Immunogenicity as measured by serum bactericidal activity at one month following immunization

Original Primary Outcome Measures ^ICMJE

To compare the immunogenicity of a single dose of either the adjuvanted or unadjuvanted formulation of Chiron MenACWY Conjugate Vaccine with the immunogenicity of a single dose of licensed meningococcal ACWY polysaccharide vaccine (Menomune®), defined as

Change History

Complete list of historical versions of study NCT00262041 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immunogenicity as measured by serum bactericidal activity at twelve months following immunization; Safety and tolerability

Original Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of a single dose of either the adjuvanted or unadjuvanted formulation of Chiron MenACWY Conjugate Vaccine compared to the safety and tolerability of a single dose of Menomune® when administered to adolescents 11 to

Descriptive Information

Brief Title ^ICMJE

Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Official Title ^ICMJE

A Phase 2, Randomized, Single-Blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of a Commercially Available Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prevention of Meningococcal Disease

Intervention ^ICMJE

Biological: Meningococcal Conjugate ACWY Vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

490

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria:

Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Gender

Both

Ages

11 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00262041

Responsible Party

Study ID Numbers ^ICMJE

V59P6

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Director:

Novartis Vaccines

Novartis

Information Provided By

Novartis

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP