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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00262028
First received: December 2, 2005
Last updated: January 31, 2008
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 administered to healthy children ages 1 - 10 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, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-Label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months 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:
  • Safety and tolerability of Chiron Meningococcal ACWY Vaccine

Estimated Enrollment: 1000
Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   12 Months to 10 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Group 1: Healthy children 2-10 years of age;
  • Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Exclusion Criteria:

  • Group 1: 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
  • Group 2: 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: NCT00262028

Locations
United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Director: Drug Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00262028     History of Changes
Other Study ID Numbers: V59P8
Study First Received: December 2, 2005
Last Updated: January 31, 2008
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 May 22, 2013