Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 1 Year and up

Hepatitis A vaccine study to see how well different doses work in adults and kids

Official title: A Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine (Human Diploid Cell) in Healthy Adults and Children Aged ≥1 Year

Run by Sinovac Biotech Co., Ltd · NCT07793227 · Data updated 2026-11-12

This Phase 3 study tests two doses of Healive for safety and immune response in adults and children, with adults receiving a single actively treated dose and children randomly receiving Healive or another HepA vaccine.

Quick facts

PhasePhase 3
Study typeInterventional
Ages1 Year and up
SexAll
Enrollment680 (estimated)
SponsorSinovac Biotech Co., Ltd
Industry-sponsored
Drugs / interventionsprednisone
Locations1 site (Hanoi)
StatusRecruiting
StartedAugust 20, 2026
Main results expectedSeptember 15, 2027
Study endsSeptember 15, 2027
Registry record updatedAugust 28, 2026
Trial IDNCT07793227 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy individuals aged 1 year or older who can provide informed consent (or guardian consent for minors) and comply with study procedures.

Probably not a fit

Individuals who have prior Hepatitis A vaccination, prior HAV infection, or pregnancy plans within the study window may be less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial combines an open-label, single-arm adult-dose cohort with a double-blind, randomized pediatric-dose cohort to compare immune responses and safety of Hepatitis A vaccines. A total of 680 healthy participants aged 1 year and older are enrolled: 200 adults receive 1.0 mL Healive, and 480 children aged 1 to under 16 are randomized 2:1 to receive either Healive 0.5 mL or Avaxim 0.5 mL, with two vaccinations at 0 and 6 months. The study assesses immunogenicity and safety outcomes, using a structured follow-up to monitor adverse events and seroconversion. Ethical conduct, informed consent, and adherence to contraception requirements are emphasized for all participants.

Why it matters

Potential benefit: If successful, the study could confirm the immunogenicity and safety of Healive across age groups and dose levels, supporting broader vaccination options.

How similar studies have gone: Similar HepA vaccine trials have demonstrated immunogenicity and acceptable safety profiles in adults and children, supporting this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy participants aged 1 year and older;
2. Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
3. Participants of reproductive potential and their sexual partners should voluntarily use effective contraception from signing the ICF to 30 days after the second vaccination and avoid donating sperm or eggs.
4. Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
5. Participants should agree to comply with the lifestyle precautions outlined in the protocol.

Exclusion Criteria:

1. Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
2. Prior history of HAV infection;
3. Female participants of reproductive potential who are pregnant (including a positive urine pregnancy test) or have a pregnancy plan within 30 days after the second vaccination, or who are currently lactating;
4. Known allergy to vaccines or vaccines ingredients;
5. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
6. Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
7. Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
8. Current or history of severe neurological diseases \[epilepsy, convulsions or seizures (excluding history of febrile seizures)\] or psychiatric disorders, or presence of a family history of psychiatric disorders;
9. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
10. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
11. Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
12. Receipt of attenuated live vaccines or nucleic acid vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
13. Fever on vaccination day, with axillary temperature \>37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
14. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
15. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
16. Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.

Where it's running

  • Hanoi Medical University
    Hanoi, Vietnam
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.