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

NCT06058416 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1092

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Healive (hepatitis A vacine(human diploid cell), inactivated)

The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.

Sponsors & Collaborators

  • Liaoning Center for Disease Control and Prevention

    collaborator OTHER

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2028-03-17
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058416 on ClinicalTrials.gov