Clinical Trial

Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old

Active, Not Recruiting Phase 4
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Summary
This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-21; most recent amendment 2024-08-20.
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-11-22
Trial Details
NCT Number NCT06058416
Lead Sponsor Sinovac Biotech Co., Ltd
Collaborators: Liaoning Center for Disease Control and Prevention
Conditions Hepatitis A
Enrollment 1,092 participants
Start Date 2023-10-24
Primary Completion 2028-03-17 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-21