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Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine
Sponsor: Sinovac Biotech Co., Ltd
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.
Official title: A 20-Year Study of the Persistence of Immunity in Healthy Children Aged 1-8 Years Induced by Inactivated Hepatitis A Vaccine
Key Details
Gender
All
Age Range
21 Years - 28 Years
Study Type
OBSERVATIONAL
Enrollment
106
Start Date
2026-08-02
Completion Date
2026-11-30
Last Updated
2026-10-22
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu, China