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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00262041
First received: December 2, 2005
Last updated: September 13, 2006
Last verified: September 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013