Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (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.

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis

Detailed Description

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
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 100-380
    • 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who receive IMOJEV® (either primary or booster dose) during a routine health-care visit

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial	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	Day 0 up to Day 42 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Kim HS, Oh Y, Korejwo J, Castells VB, Yang K. Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019. Infect Dis Ther. 2020 Sep;9(3):589-598. doi: 10.1007/s40121-020-00305-6. Epub 2020 May 30.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2016
• Primary Completion (ACTUAL): October 18, 2018
• Study Completion (ACTUAL): October 18, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (ESTIMATE): October 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: JEC18; U1111-1174-4824 (OTHER: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes