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