Postmarketing Surveillance Study for IMOJEV® in Republic of Korea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933710|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : April 25, 2022
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.
- To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea|
|Actual Study Start Date :||July 21, 2016|
|Actual Primary Completion Date :||October 18, 2018|
|Actual Study Completion Date :||October 18, 2018|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933710
|Korea, Republic of|
|Seoul, Korea, Republic of, 100-380|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|