Clinical Trials Directory

Trials / Completed

CompletedNCT00772369

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children

Status
Completed
Phase
Study type
Observational
Enrollment
3,214 (actual)
Sponsor
Sanofi Pasteur, a Sanofi Company · Industry
Sex
All
Age
12 Months – 24 Months
Healthy volunteers
Accepted

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 4th dose of the Pentacel® series before their 2nd birthday.

Conditions

Timeline

Start date
2003-09-01
Primary completion
2004-04-01
Completion
2005-04-01
First posted
2008-10-15
Last updated
2014-02-14
Results posted
2010-04-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00772369. Inclusion in this directory is not an endorsement.