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Clinical Trials in China / NCT06058416
Active, not recruiting Phase 4

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

NCT06058416 · tracked via the Priya Life Science China tracker
Sponsor
Sinovac Biotech Co., Ltd
Phase
Phase 4
Started
2023-10-24
Last updated
2024-08-21

Condition(s) studied

Hepatitis A

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18-50; * Adults can understand and sign the informed consent form voluntarily; * Adults can provide valid and legal identity certificate. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month — 28 days after two dose of vaccination of hepatitis A vaccine
  • Incidence of adverse reaction within 28 days after one dose of vaccination — 28 days after one dose of vaccination

Trial sites (1)

FacilityCityRegionStatus
Liaoning Center for Disease Control and Prevention Shenyang Liaoning

More Sinovac Biotech Co., Ltd trials in China

Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations Recruiting
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). Starting soon
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine Recruiting
A Phase IV Clinical Trial of Influenza Vaccine (Split Virion), Inactivatedin (Anflu®) Pregnant Women (AnFLU-PREG) Starting soon
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months Recruiting

Other trials for the same condition

Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine Recruiting
Phase IV Study of Concomitant Administration of the sIPV and HepA Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06058416 on ClinicalTrials.gov ↗ ← All trials in China