Clinical Trial: Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational Post Authorisation Safety Study to Describe the Safety Profile of the Diphtheria, Tetanus, Acellular Pertussis Combination Vaccine, Reduced Antigen Content (

Brief Summary: Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children

Detailed Summary:
Sponsor: MCM Vaccines B.V.

Current Primary Outcome: all injection site and systemic Adverse Events [ Time Frame: for 30 days following vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: MCM Vaccines B.V.

Dates:
Date Received: April 20, 2012
Date Started: March 2012
Date Completion:
Last Updated: August 3, 2012
Last Verified: August 2012