drugset / Trial / NCT01137435
Post Marketing Surveillance for ADACEL™ in South Korea
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2010-06
- Primary completion
- 2016-03
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adacel | Vaccine | 0.5 ml | Intramuscular |