Clinical Trial

Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas

Active, Not Recruiting Phase 4
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Record status
This record was last updated December 13, 2024 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to assess the neutralizing antibody levels and prevalence risk of Japanese encephalitis among residents in low-endemic areas, as well as to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in healthy populations. The study uses an open-label, single-arm trial design with a sample size of 250 participants. Primary endpoints include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, and incidence of adverse events.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-06; most recent amendment 2024-12-12.
Status change: Not Yet Recruiting → Active, Not Recruiting 2024-12-12
Trial Details
NCT Number NCT06678373
Lead Sponsor Liaoning Chengda Biotechnology CO., LTD
Conditions Japanese Encephalitis
Enrollment 250 participants
Start Date 2024-11-14
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-13