Can a new vaccine shield more people from hepatitis a?

NCT ID NCT07793227

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests an inactivated hepatitis A vaccine called Healive in healthy people aged 1 year and older. Researchers will measure how well the vaccine triggers protective antibodies and check its safety. Adults receive the vaccine in an open-label group, while children are randomly assigned to get either Healive or a comparator vaccine. All participants get two doses, six months apart, and the immune response is measured 30 days after the second dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inactivated hepatitis A vaccine (human diploid cell), known as Healive
What this could lead to
If successful, this could support the vaccine's approval for broader use, helping protect more people from hepatitis A infection.
What could go wrong
The trial is still in phase 3, so the vaccine may not prove as effective or safe as hoped. Side effects, though usually mild, can occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hanoi Medical University

    RECRUITING

    Hanoi, Vietnam