NCT06372665

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

Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15,357 (actual)
• Sponsor: Liaoning Chengda Biotechnology CO., LTD · Industry
• Sex: All
• Age: 8 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Japanese Encephalitis

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-04-18
• Last updated: 2025-08-28

Locations

1 site across 1 country: China