Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea

Summary

The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: * To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Timeline

Start

2016-07-21

Primary completion

2019-06-12

Completion

2019-06-12

Publications

• Kim HS, Engel S, Neveu D, Thollot Y, Oster P, Yang K. Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra(R)) in the Republic of Korea, 2014-2019. Infect Dis Ther. 2021 Mar;10(1):399-409. doi: 10.1007/s40121-020-00393-4. Epub 2021 Jan 13.

Drugs

Indications