Trials / Completed
CompletedNCT00258882
Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 327,293 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tetanus Toxoid, acellular pertussis, diphtheria toxoid | 0.5 mL, Intramuscular |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2011-07-01
- Completion
- 2012-12-01
- First posted
- 2005-11-28
- Last updated
- 2018-07-17
- Results posted
- 2016-04-13
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00258882. Inclusion in this directory is not an endorsement.