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

Meningitis Clinical Trial

Official title:
Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea

Clinical Trial 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.

Clinical Trial Description

Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study. They will be followed-up for up to Day 42 following vaccination. No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02864927
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date July 21, 2016
Completion date June 12, 2019
View Details
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