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

NCT01583049 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2017-09-11

No results posted yet for this study

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

  • Diphtheria, Tetanus and Pertussis

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583049 on ClinicalTrials.gov