Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

NCT02933710 | Completed

• 2 other identifiers: JEC18U1111-1174-4824
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Japanese Encephalitis

Keywords

Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

001

Seoul, 100-380, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32474892 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: July 21, 2016
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)