Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
- Conditions
- Hepatitis A
- Registration Number
- NCT06058416
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1092
Inclusion Criteria:<br><br> - Adults aged 18-50;<br><br> - Adults can understand and sign the informed consent form voluntarily;<br><br> - Adults can provide valid and legal identity certificate.<br><br>Exclusion Criteria:<br><br> - A history of hepatitis A infection;<br><br> - Previously vaccinated with inactivated hepatitis A vaccine, live attenuated<br> hepatitis A vaccine, or hepatitis A and B combined vaccine;<br><br> - Allergic constitution or have severe allergic reaction to vaccines in the past (such<br> as acute allergic reaction, angioedema, dyspnea, etc.);<br><br> - Pregnant women and lactating women;<br><br> - People suffering from uncontrolled epilepsy and other serious neurological diseases<br> (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases,<br> etc.);<br><br> - Patients with fever during vaccination, or acute exacerbation of chronic diseases,<br> or patients with uncontrolled severe chronic diseases, or suffering from acute<br> diseases;<br><br> - Received other research drugs within 30 days before vaccination with the<br> experimental vaccine;<br><br> - Have received a live attenuated vaccine within 14 days before vaccination with the<br> experimental vaccine;<br><br> - Have received subunit or inactivated vaccine within 7 days before vaccination with<br> experimental vaccine;<br><br> - Other conditions that are not suitable for vaccination judged by the researcher.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month;Incidence of adverse reaction within 28 days after one dose of vaccination
- Secondary Outcome Measures
Name Time Method