Clinical Trials Directory

Trials / Completed

CompletedNCT02933710

Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Sanofi Pasteur, a Sanofi Company · Industry
Sex
All
Age
12 Months
Healthy volunteers
Accepted

Summary

The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: * To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.

Detailed description

Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study. No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Conditions

Timeline

Start date
2016-07-21
Primary completion
2018-10-18
Completion
2018-10-18
First posted
2016-10-14
Last updated
2022-04-25

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02933710. Inclusion in this directory is not an endorsement.