Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Liaoning Chengda Biotechnology

Status: Completed

Conditions: Japanese Encephalitis

Study type: Observational

Funder types: Industry

Identifiers

NCT06372665

CDB-IV-JE-025202301

Details and patient eligibility

About

This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.

Full description

Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.

The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.

Enrollment: 15,357 patients

Sex: All

Ages: 8+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children who have received the inactivated Japanese encephalitis vaccine.
• Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
• Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.

Exclusion criteria

-

Trial design

15,357 participants in 1 patient group

Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Group

Description:

Healthy children aged 8 months and above who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province