Trials / Completed
CompletedNCT01040052
A Study to Assess the Safety of Adacel® Vaccine
A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration. Primary objective: To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.
Detailed description
Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety. An additional visit will be conducted 30 days post-vaccination to collect safety information.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) | 0.5 mL, Intramuscular |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2010-02-01
- Completion
- 2010-04-01
- First posted
- 2009-12-25
- Last updated
- 2016-05-16
- Results posted
- 2011-03-29
Locations
1 site across 1 country: Vietnam
Source: ClinicalTrials.gov record NCT01040052. Inclusion in this directory is not an endorsement.