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Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis

NCT06825312 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-03-11

No results posted yet for this study

Summary

The main objective of this study is to evaluate the persistence of Japanese encephalitis antibodies in participants at the age of 6, after they have followed different Japanese encephalitis vaccination schedules. Furthermore, the study will assess the immunogenicity and antibody persistence of primary immunization across different Japanese encephalitis vaccination schedules, as well as the immunogenicity following booster immunizations within these schedules. The safety of each vaccine dose will also be evaluated.

Conditions

  • Japanese Encephalitis Vaccine

Interventions

BIOLOGICAL

Japanese Encephalitis Vaccine (Vero Cell), Inactivated

0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology Co., Ltd., administered in the deltoid area of lateral arm by intramuscular injection.

BIOLOGICAL

Japanese Encephalitis Vaccine, Live

0.5ml for each dose, manufactured by Chengdu Institute of Biological Products Co., Ltd., administered subcutaneously in the lower part of the deltoid area of lateral arm.

Sponsors & Collaborators

  • Zhejiang Provincial Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Liaoning Chengda Biotechnology CO., LTD

    lead INDUSTRY

Principal Investigators

  • Huanyu Wang · Liaoning Chengda Biotechnology CO., LTD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-11
Primary Completion
2030-12-31
Completion
2031-12-31

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 NCT06825312 on ClinicalTrials.gov