Database Surveillance Safety Study of PENTACEL® Vaccine
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2008 |
| End Date: | January 2015 |
Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
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.
identification of potential vaccine-related adverse events not currently associated with
PENTACEL® vaccine administration.
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.
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.
Inclusion Criteria:
- Receipt of DTaP vaccine during the study period by a previously unvaccinated child
Exclusion Criteria:
We found this trial at
1
site
Click here to add this to my saved trials
