Clinical Trial: REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-Old Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined
Brief Summary:
Primary objective:
To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .
Secondary objectives:
- Additional immunogenicity assessments.
- To describe the safety profile of a single dose of REVAXIS® or DT-Polio®
Detailed Summary:
Sponsor: MCM Vaccines B.V.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: MCM Vaccines B.V.
Dates:
Date Received: March 12, 2007
Date Started: February 2007
Date Completion:
Last Updated: April 3, 2009
Last Verified: April 2009