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Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Sponsor: Liaoning Chengda Biotechnology CO., LTD
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.
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-11-14
Completion Date
2026-12-31
Last Updated
2024-12-13
Healthy Volunteers
Yes
Conditions
Interventions
Liaoning Chengda Inactivated Japanese Encephalitis Vaccine
The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine.
Liaoning Chengda Inactivated Japanese Encephalitis Vaccine
The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days.
Liaoning Chengda Inactivated Japanese Encephalitis Vaccine
The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days.
Locations (1)
Liaoning Provincial Center for Disease Control and Prevention
Shenyang, Liaoning, China