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