An observational study in Japanese Encephalitis, sponsored by Liaoning Chengda Biotechnology CO., LTD. Completed at 1 site in China. Open to participants aged 8 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Liaoning Chengda Biotechnology CO., LTD · Observational
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.
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.
74 studies on the registry are indexed under Encephalitis, Japanese; 3 are open to participants now.
Browse Encephalitis, Japanese studies →Liaoning Chengda Biotechnology CO., LTD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy children aged 8 months and above who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province
Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events
Adverse events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but they may not necessarily have a causal relationship with the investigational drug. Unsolicited AEs will be collected within 30 days after each dose of vaccine administration, while solicited adverse reactions will be collected within 30 minutes and 30 minutes to 7 days after each dose of vaccine administration. A structured form (pre-listed) will be used to record the local and systemic reactions collected below. Local reactions: * Pain * Induration * Ecchymosis (Redness) * Pruritus * Rash Systemic reactions: * Headache * Courbature (not from injection site) * Diarrhea * Dysphagia * Anorexia * Vomiting * Sickness * Cough * Dyspnea * Irritability * Sleepiness * Acute allergic reaction * Pain (not from injection site)
Time frame: 30 days following each vaccination
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Liaoning Chengda Biotechnology CO., LTD