Clinical Trial: Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of Fractional Booster Dose of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intrade
Brief Summary:
The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety.
Objectives:
- To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study.
- To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.
Detailed Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome:
- Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. [ Time Frame: 30 days post-vaccination ]
- Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine [ Time Frame: 30 days post-vaccination and entire study duration ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: April 20, 2009
Date Started: April 2009
Date Completion:
Last Updated: January 20, 2014
Last Verified: January 2014
