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NCT02933710 Clinical Trial

Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Japanese Encephalitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02933710
Other study ID # JEC18
Secondary ID U1111-1174-4824
Status Completed
Phase
First received
Last updated
Start date July 21, 2016
Est. completion date October 18, 2018

Study information
Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 18, 2018
Est. primary completion date October 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months and older
Eligibility Inclusion Criteria: - Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age) - Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper. Exclusion Criteria: - Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure. - Subjects who already participated in this study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of 001 Seoul

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (12 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 years and above, Fever (Temperature), Headache, Malaise, and Myalgia Day 0 up to Day 42 post-vaccination
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