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

This study has been completed.

First Received: December 2, 2005 Last Updated: September 13, 2006 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00262041

Purpose

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.

Condition	Intervention	Phase
Prevention of Meningococcal Disease	Biological: Meningococcal Conjugate ACWY Vaccine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Childhood Immunization

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	490
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262041

Locations

United States, Minnesota

Rochester, Minnesota, United States, 55905
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15241
United States, Washington

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines

Novartis

More Information

No publications provided

Study ID Numbers:	V59P6
Study First Received:	December 2, 2005
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00262041 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on March 18, 2010