Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
NCT ID: NCT06058416
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
1092 participants
INTERVENTIONAL
2023-10-24
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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immunogenicity group with vaccination interval of 6 month
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.
immunogenicity group with vaccination interval of 18 month
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.
immunogenicity group with vaccination interval of 36 month
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.
immunogenicity group with vaccination interval of 60 month
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.
safety observation group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Adults can understand and sign the informed consent form voluntarily;
* Adults can provide valid and legal identity certificate.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Liaoning Center for Disease Control and Prevention
OTHER
Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Liaoning Center for Disease Control and Prevention
Shenyang, Liaoning, China
Countries
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References
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Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.
Iwarson S, Lindh M, Widerstrom L. Excellent booster response 4 to 8 years after a single primary dose of an inactivated hepatitis A vaccine. J Travel Med. 2004 Mar-Apr;11(2):120-1. doi: 10.2310/7060.2004.17079. No abstract available.
Related Links
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WHO position paper on hepatitis A vaccines-October2022
Other Identifiers
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PRO-HAV-MA4001-LN
Identifier Type: -
Identifier Source: org_study_id
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