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

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Mar 17, 2024 to Mar 17, 2028
    • Eligibility criteria expanded, about 1 word
    v3
  2. Trial status: Not Yet Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Enrollment target: estimated 1000 to confirmed 1092
    • Study sites: 0 to 1
    • Primary completion date: Oct 17, 2023 to Mar 17, 2024
    • Start date changed from estimate of Oct 11, 2023 to Oct 24, 2023
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06058416
Lead Sponsor Sinovac Biotech Co., Ltd
Collaborators: Liaoning Center for Disease Control and Prevention
Conditions
(from sponsor)		 Hepatitis A
Related terms Hepatitis, Hepatitis A
Enrollment 1,092 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov