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Clinical Trials in China / NCT07889219
Recruiting Observational

Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine

NCT07889219 · tracked via the Priya Life Science China tracker
Sponsor
Sinovac Biotech Co., Ltd
Phase
Observational
Started
2026-08-02
Last updated
2026-10-22

Condition(s) studied

Hepatitis A

Investigational drug(s) / intervention(s)

Healive®Havrix® →

Healive®: Healive® developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, two doses administered in the prior trial.

Havrix®: The control vaccine (0.5 mL/dose) contained 720 ELISA units (El.U) antigen and 0.25 mg alum with 2-phenoxyethanol as preservative.

Study summary

This study is a single-center, open-label, controlled study. Its primary objective is to evaluate the 20-year persistence of immunity induced by the inactivated hepatitis A vaccine. At least 106 healthy participants aged 21-28 years will be enrolled. Participants will be selected from individuals who completed the full vaccination course in the PRO-HA-4006 clinical study (Three-Batch Consistency Study of Healive® in Healthy Children Aged 1-8 Years in Changzhou) . After voluntarily providing informed consent, each participant will undergo one venous blood collection of approximately 3.0 mL for hepatitis A antibody testing to assess the persistence of immunity induced by the hepatitis A vaccine.

Eligibility

Sex
ALL
Min age
21 Years
Max age
28 Years
Healthy volunteers
Accepted
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for this study: 1. Healthy participants aged 21-28 years who previously participated in PRO-HA-4006 and completed the full vaccination course; 2. Participants who are able to understand and voluntarily sign the informed consent form; 3. Provision of valid legal identification. Exclusion Criteria: Individuals meeting any of the following criteria will be excluded from this study: 1. History of hepatitis A virus infection; 2. Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4006 clinical study; 3. Autoimmune disease or immunodeficiency/immunosuppression; 4. Coagulation abnormalities, such as coagulation factor deficiency or platelet abnormalities, or a history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture; 5. In the investigator's judgment, any other factor that makes the participant unsuitable for participation in the clinical study.

Primary outcome measure(s)

  • Seropositivity rate and geometric mean concentration (GMC) of hepatitis A antibodies at Year 20 after vaccination. — 20 years after vaccination
    Evaluate the immune persistence of anti-HAV antibodies in serum 20 years after two doses of inactivated hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.

Trial sites (1)

FacilityCityRegionStatus
Changzhou City Center for Disease Control and Prevention Changzhou Jiangsu Recruiting

More Sinovac Biotech Co., Ltd trials in China

Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations Recruiting
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Active, not recruiting
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). Starting soon
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine Recruiting
A Phase IV Clinical Trial of Influenza Vaccine (Split Virion), Inactivatedin (Anflu®) Pregnant Women (AnFLU-PREG) Starting soon

Other trials for the same condition

Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Active, not recruiting
Phase IV Study of Concomitant Administration of the sIPV and HepA Starting soon
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 NCT07889219 on ClinicalTrials.gov ↗ ← All trials in China