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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02933710

Enrollment

Registered

2016-10-14

Start date

2016-07-21

Completion date

2018-10-18

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese Encephalitis

Keywords

Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results