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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06372665
Study type Observational
Source Liaoning Chengda Biotechnology CO., LTD
Contact Li Tong
Phone +86 15811315908
Email 14877107@qq.com
Status Recruiting
Phase
Start date January 1, 2024
Completion date June 30, 2025

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