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Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Japanese Encephalitis

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 12 Months to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Seoul, South Korea