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
Sponsor study identifier
observational
15,357
1 country
1
Study Start
January 1, 2024
Actual (reported)Primary Completion
April 30, 2025
Actual (reported)Study Completion
April 30, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Actual (reported)April 15, 2024
Actual (reported)April 18, 2024
Actual (reported)April 30, 2025
Actual (reported)April 30, 2025
Actual (reported)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)
30 days following each vaccination
Healthy children aged 8 months and above who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province
Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
Liu L, Zhang L, Hu R, Kang G, Yu J, Sun X, Wang Z. An active surveillance study of adverse events following to Japanese encephalitis inactivated vaccine (JE-I) in Jiangsu Province, China, 2024-2025. Expert Rev Vaccines. 2026 Dec;25(1):2653748. doi: 10.1080/14760584.2026.2653748. Epub 2026 Apr 14.
Huanyu Wang
Liaoning Chengda Biotechnology CO., LTD
15,357 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2024
First Posted
April 18, 2024
Study Start
January 1, 2024
Actual (reported)Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
Contact the study team to confirm eligibility.
Primary Completion
April 30, 2025
Actual (reported)Study Completion
April 30, 2025
Actual (reported)Last Updated
August 28, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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