Status:
ACTIVE_NOT_RECRUITING
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
Lead Sponsor:
Sinovac Biotech Co., Ltd
Collaborating Sponsors:
Liaoning Center for Disease Control and Prevention
Conditions:
Hepatitis A
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 screene...
Eligibility Criteria
Inclusion
- Adults aged 18-50;
- Adults can understand and sign the informed consent form voluntarily;
- Adults can provide valid and legal identity certificate.
Exclusion
- A history of hepatitis A infection;
- Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine;
- Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.);
- Pregnant women and lactating women;
- People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.);
- Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases;
- Received other research drugs within 30 days before vaccination with the experimental vaccine;
- Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine;
- Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine;
- Other conditions that are not suitable for vaccination judged by the researcher.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2029
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT06058416
Start Date
October 24 2023
End Date
December 31 2029
Last Update
August 21 2024
Active Locations (1)
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1
Liaoning Center for Disease Control and Prevention
Shenyang, Liaoning, China