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Immunogenicity and Safety of Men ACWY in Infants (6 & 12 Months)

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00310856
First received: April 3, 2006
Last updated: April 16, 2008
Last verified: April 2008
History of Changes
  Purpose

To assess the immunogenicity of Chiron Men ACWY conjugate vaccine (Men ACWY) when administered as a two-dose schedule at 6 and 12 months of age.


Condition Intervention Phase
Meningococcal Meningitis
 Biological: Meningococcal ACWY conjugate 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, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of a Commercially Available Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

Resource links provided by NLM:

MedlinePlus related topics: Meningitis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • immunogenicity as measured by serum bactericidal activity and GMTs when administered at 6 and 12 months of age.

Secondary Outcome Measures:
  • booster response of C component of the vaccine when administered at 18 months of age, after second immunization at 12 months, as measured serum bactericidal activity and GMTs. Safety and tolerability.

Estimated Enrollment: 175
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants 6 months of age who previously received two doses of both heptavalent conjugate pneumococcal and DTaP-Hib-IPV vaccines
  • healthy subjects 12 months of age who previously received 3 doses of DTaP-Hib-IPV vaccine

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: NCT00310856

Locations
Canada, Ontario
Herridge Community Health Clinic
Ottawa, Ontario, Canada
Canada
Clinical Trials Research Center, Department of Pediatrics, Dalhousie University IWK Health Center
Halifax, Canada, B3K 6R8
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Canada
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Principal Investigator: Novartis Vaccines - Drug Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310856     History of Changes
Other Study ID Numbers: V59P9
Study First Received: April 3, 2006
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
meningitis
children
vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
 Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013