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Recruiting NCT07889219

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

Conditions: Hepatitis A

Sex: All
Ages: 21 Years – 28 Years
Healthy volunteers: Yes
Enrollment: 106
Sponsor: Sinovac Biotech Co., Ltd

Location: Changzhou City Center for Disease Control and Prevention Changzhou Jiangsu

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07889219). StuddyBuddy aggregates publicly available trial information.