Postmarketing Surveillance Study for IMOJEV® in Republic of 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.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

001

Seoul, 100-380, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: Day 0 up to Day 42 post-vaccination

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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Oct 14, 2016
Registry last updated: Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed