Immunogenicity and Safety of Men ACWY in Infants (6 & 12 Months)
This study has been completed.
Information provided by:
First received: April 3, 2006
Last updated: April 16, 2008
Last verified: April 2008
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.
Biological: Meningococcal ACWY conjugate vaccine
|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:
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.
|Study Start Date:||June 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310856
|Herridge Community Health Clinic|
|Ottawa, Ontario, 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|
Sponsors and Collaborators
|Principal Investigator:||Novartis Vaccines - Drug Information Services||Novartis Vaccines & Diagnostics|