Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/19/2018 |
| Start Date: | January 2006 |
| End Date: | December 2012 |
Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
To further characterize the vaccine safety profile and to identify any signals of potentially
vaccine-related adverse events (AEs) not detected during pre-licensure studies.
vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Surveillance using a healthcare organization with large comprehensive medical encounter
databases will be used in this study to identify any risks or uncommon events associated with
use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a
large population.
No investigational vaccines will be administered in this study. Participants will be included
in the study on the basis of their having received Adacel vaccine as part of routine care.
databases will be used in this study to identify any risks or uncommon events associated with
use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a
large population.
No investigational vaccines will be administered in this study. Participants will be included
in the study on the basis of their having received Adacel vaccine as part of routine care.
Inclusion Criteria:
- Receipt of ADACEL vaccine during the study period
Exclusion Criteria:
We found this trial at
3
sites
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