Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-21

Study Completion Date

2018-10-18

Brief Summary

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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.

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Detailed Description

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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

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Japanese Encephalitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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IMOJEV® Vaccine Group

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes