Postmarketing Surveillance Study for IMOJEV® in Republic of Korea

• ClinicalTrials.gov Identifier: NCT02933710
• Recruitment Status: Completed
• First Posted: October 14, 2016
• Last Update Posted: April 25, 2022
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 12 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Locations

Korea, Republic of

001

Seoul, Korea, Republic of, 100-380

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02933710
• Other Study ID Numbers: JEC18; U1111-1174-4824 ( Other Identifier: WHO )
• First Posted: October 14, 2016
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• 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

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine

Additional relevant MeSH terms:

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