Trials / Completed
CompletedNCT01583049
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
Observational Post Authorisation Safety Study to Describe the Safety Profile of the Diphtheria, Tetanus, Acellular Pertussis Combination Vaccine, Reduced Antigen Content (Triaxis) as a 5th Dose in 4-6 Year Old Spanish Children
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 556 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Accepted
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
Conditions
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2012-04-23
- Last updated
- 2017-09-11
Locations
22 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01583049. Inclusion in this directory is not an endorsement.