drugset / Trial / NCT06678373

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

NCT06678373 ↗

Phase 4 Active not recruiting 250 enrolled Liaoning Chengda Biotechnology CO., LTD
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2024-11-14
Primary completion
2026-04-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Liaoning Chengda Inactivated Japanese Encephalitis Vaccine Vaccine — —

Indications