Database Surveillance Safety Study of PENTACEL® Vaccine

Status Completed

Clinical Trial Summary

The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.

Clinical Trial Description

The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.

Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events. ;

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00804284
Study type	Observational
Source	Sanofi
Contact
Status	Completed
Phase	N/A
Start date	September 2008
Completion date	January 2015

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