drugset / Trial / NCT01137435

Post Marketing Surveillance for ADACEL™ in South Korea

NCT01137435

Phase 4 Completed 659 enrolled Sanofi Pasteur, a Sanofi Company
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

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine 0.5 ml Intramuscular