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

NCT06825312 · tracked via the Priya Life Science China tracker

Sponsor

Liaoning Chengda Biotechnology CO., LTD

Phase

Phase 4

Started

2023-11-11

Last updated

2026-09-02

Condition(s) studied

Japanese Encephalitis Vaccine

Investigational drug(s) / intervention(s)

Japanese Encephalitis Vaccine (Vero Cell), InactivatedJapanese Encephalitis Vaccine, Live

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.

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.

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.

Eligibility

Sex

ALL

Min age

8 Months

Max age

8 Months

Healthy volunteers

Accepted

Inclusion Criteria: * Healthy children aged 8 months who are permanent residents of the study area. * Legal guardians can understand the requirements and processes of the study, provide written informed consent, and comply with all procedures as required by the clinical research protocol. * Able to receive the full course of Japanese encephalitis vaccinations according to the immunization strategy in the research protocol, including receiving the primary immunization at 8 months of age and the booster immunizations at 24 months of age and 6 years of age. Exclusion Criteria: * Unable to finish the full course of primary and booster immunizations at the study area, and unable to fulfill the follow-up visits prescribed in the protocol. * Non-compliance with the vaccination strategy for each group, as stated in the protocol, regarding Japanese encephalitis vaccines with proper doses and varieties. * Allergic to any component of the study vaccine or having a history of allergic reactions to any vaccines. * Having a history of symptoms or signs of neurological diseases or other contraindications for Japanese encephalitis vaccine vaccination. * Having used immunosuppressants or blood products following birth. * Receiving other vaccines simultaneously while receiving the Japanese encephalitis vaccine of this project. * Any conditions that may interfere with the evaluation of the study, as deemed by the researcher.

Primary outcome measure(s)

Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies — 4 years after the booster vaccination at 24 months of age
The persistence of immunity following various Japanese encephalitis (JE) vaccination schedules is evaluated based on the proportion of participants exhibiting seropositivity for JE neutralizing antibodies at 6 years of age. Seropositivity is defined as a JE neutralizing antibody titer of at least 1:10, as ascertained by the 50% plaque reduction neutralization test.

Trial sites (6)

Facility	City	Region
Jiashan County Center for Disease Control and Prevention	Jiaxing	Zhejiang
Pinghu Center For Disease Control and Prevention	Jiaxing	Zhejiang
Dongyang Center for Disease Control and Prevention	Jinhua	Zhejiang
Yongkang Center for Disease Control and Prevention	Jinhua	Zhejiang
Yuyao Center for Disease Control and Prevention	Ningbo	Zhejiang
Jiangshan Center For Disease Control and Prevention	Quzhou	Zhejiang

More Liaoning Chengda Biotechnology CO., LTD trials in China

Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations Recruiting

Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06825312 on ClinicalTrials.gov ↗ ← All trials in China