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

NCT06678373 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-12-13

No results posted yet for this study

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.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Liaoning Chengda Inactivated Japanese Encephalitis Vaccine

The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine.

BIOLOGICAL

Liaoning Chengda Inactivated Japanese Encephalitis Vaccine

The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days.

BIOLOGICAL

Liaoning Chengda Inactivated Japanese Encephalitis Vaccine

The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days.

Sponsors & Collaborators

  • Liaoning Chengda Biotechnology CO., LTD

    lead INDUSTRY

Principal Investigators

  • Xing Fang · Liaoning Provincial Center for Disease Control and Prevention

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678373 on ClinicalTrials.gov