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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00262002
First received: December 2, 2005
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Chiron Meningococcal ACWY Conjugate Vaccine administered to healthy infants.


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: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity as measured by serum bactericidal activity at one month following 3rd vaccination

Secondary Outcome Measures:
  • Immune response following 2nd immunization and memory response at 12 months of age; Safety and tolerability

Estimated Enrollment: 600
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   55 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 2-month old infants born after full-term pregnancy

Exclusion Criteria:

  • Subjects who previously received any meningococcal vaccine; Subjects with any serious, acute or chronic progressive disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262002

Locations
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines Novartis Vaccines & Diagnostics
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00262002     History of Changes
Other Study ID Numbers: V59P5, 2004-000195-13
Study First Received: December 2, 2005
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 16, 2014