Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This study has been completed.
Information provided by:
First received: February 11, 2008
Last updated: January 20, 2010
Last verified: January 2010
This is a follow-up of Study A3L10. Immunogenicity
- To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
- To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.
- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.
Biological: DTaP-IPV-HB-PRP~T vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Resource links provided by NLM:
MedlinePlus related topics: Diphtheria Hepatitis Hepatitis A Hepatitis B Polio and Post-Polio Syndrome Whooping Cough
Genetic and Rare Diseases Information Center resources: Whooping Cough Haemophilus Influenzae Diphtheria Poliomyelitis MyelitisU.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Immunogenicity -Antibody persistence in a subset and booster response in all subjects [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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