Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Sanofi

Status: Completed

Conditions: Japanese Encephalitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02933710

JEC18

U1111-1174-4824 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 12+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

IMOJEV® Vaccine Group

Description:

Participants who are 12 months and older and who are given a first dose of IMOJEV® during a routine health care visit