CompletedNot Applicable

Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

South Korea50 participantsStarted 2016-07-21

Plain-language 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.

Who can participate

Age range12 Months

SexALL

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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.

What they're measuring

Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial

Timeframe: Day 0 up to Day 42 post-vaccination

Trial details

NCT IDNCT02933710

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-10-18

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