Status:

COMPLETED

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Lead Sponsor:

Sanofi Pasteur, a Sanofi Company

Conditions:

Diphtheria

Pertussis

Eligibility:

All Genders

12-24 years

Brief Summary

The purpose of this survey is to collect selected safety data. Primary Objective: To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.

Detailed Description

This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4...

Eligibility Criteria

Inclusion

  • Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
  • Written Informed Consent and Telephone consent from the parent(s) or guardian(s).
  • Able to comply with the survey procedures.

Exclusion

  • Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.

Key Trial Info

Start Date :

September 1 2003

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2005

Estimated Enrollment :

3214 Patients enrolled

Trial Details

Trial ID

NCT00772369

Start Date

September 1 2003

End Date

April 1 2005

Last Update

February 14 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Vancouver, British Columbia, Canada, V5Z 4R4