Trials / Completed
CompletedNCT01137435
Post Marketing Surveillance for ADACEL™ in South Korea
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 659 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 11 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug". The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined | 0.5 mL, intramuscular (IM) |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2016-03-01
- Completion
- 2016-09-01
- First posted
- 2010-06-04
- Last updated
- 2022-04-28
- Results posted
- 2017-01-04
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01137435. Inclusion in this directory is not an endorsement.