Regulatory Post-Marketing Surveillance Study for TETRAXIM™

Summary

The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Timeline

Start

2011-06

Primary completion

2015-11

Completion

2015-11

Publications

• Choe YJ, Vidor E, Manson C. Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015. Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 2022 May 14.

Drugs

Indications