Hepatitis A VaccinePhase 3NCT07793227
Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine
A Phase 3 study testing Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL), Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) and Hepatitis A vaccine (inactivated, adsorbed) in people with Hepatitis A Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in Vietnam.
Trial summary
This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage). Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A Vaccine
- What is being tested?
- Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL), Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) and Hepatitis A vaccine (inactivated, adsorbed)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Aug 2026to 15 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy participants aged 1 year and older;
- Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
- 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.
- Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
- Participants should agree to comply with the lifestyle precautions outlined in the protocol.
Who cannot join
- Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
- Prior history of HAV infection;
- 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;
- Known allergy to vaccines or vaccines ingredients;
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
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- 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;
- 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;
- 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;
- Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
- Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
- 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;
- Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
- 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;
- Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
- Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Medical University
Hanoi
Van Anh Thi Pham, 84 915595690, phamthivananh.hmu@gmail.com
About this study
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
This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage).
A total of 680 healthy participants aged 1 year and above will be enrolled, including 200 participants aged 16 years and older (adult dose group), and 480 participants aged 1 to less than 16 years (pediatric dose group).
Read more
For the adult dose group: open-label, single-arm design, 200 participants aged 16 years and above will be enrolled to receive Healive® (1.0 mL).
For the pediatric dose group: double-blinded, randomized, positive-controlled design, 480 participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratio to receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receive two doses of either Healive® or Avaxim® at 0 and 6 months.
- Conditions
- Hepatitis A Vaccine
- Being tested
- Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL), Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL), Hepatitis A vaccine (inactivated, adsorbed)
- Keywords
- Hepatitis A Vaccine, Immunogenicity, Safety
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)Biological
Also called Healive® (1 mL)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)Biological
Also called Healive® (0.5 mL)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1~<16 years)
Hepatitis A vaccine (inactivated, adsorbed)Biological
Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
| Study group | Role | What they receive |
|---|---|---|
| Adult dose, treatment group (≥16 years) | Experimental | Not described Receives: Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) |
| Pediatric dose, treatment group (6~ <16 years) | Experimental | Not described Receives: Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) |
| Pediatric dose, control group (6~ <16 years) | Active comparator | Not described Receives: Biological: Hepatitis A vaccine (inactivated, adsorbed) |
| Pediatric dose, treatment group (1~ <6 years) | Experimental | Not described Receives: Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) |
| Pediatric dose, conrol group (1~ <6 years) | Active comparator | Not described Receives: Biological: Hepatitis A vaccine (inactivated, adsorbed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of anti-HAV antibodies
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
Measured: 30 days after the second vaccination
Secondary outcomes (6)
Seropositive rate of anti-HAV antibodies
The seropositive rate of anti-HAV antibodies 30 days after the second vaccination
Measured: 30 days after the second vaccination
Geometric mean concentration (GMC) of anti-HAV antibodies
The geometric mean concentration (GMC) of anti-HAV antibodies 30 days after the second vaccination
Measured: 30 days after the second vaccination
Geometric mean fold rise (GMFR) of anti-HAV antibodies
The geometric mean fold rise (GMFR) of anti-HAV antibodies 30 days after the second vaccination
Measured: 30 days after the second vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Incidence of adverse events (AE)/adverse reactions (AR) within 30 days after each vaccination
Measured: 30 days after each vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Incidence of AE/AR within 7 days after each vaccination
Measured: 7 days after each vaccination
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) from first vaccination to 30 days after second vaccination
Measured: From first vaccination to 30 days after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start20 Aug 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis A VaccineStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DUC MINH MEDICAL JSC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793227
- Sponsor's protocol ID
- PRO-HAV-4018
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07793227
- Acronym / sponsor ID
- PRO-HAV-4018
- Conditions
- Hepatitis A Vaccine
- Keywords
- Hepatitis A Vaccine, Immunogenicity, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- DUC MINH MEDICAL JSC.
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage).
A total of 680 healthy participants aged 1 year and above will be enrolled, including 200 participants aged 16 years and older (adult dose group), and 480 participants aged 1 to less than 16 years (pediatric dose group).
For the adult dose group: open-label, single-arm design, 200 participants aged 16 years and above will be enrolled to receive Healive® (1.0 mL).
For the pediatric dose group: double-blinded, randomized, positive-controlled design, 480 participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratio to receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receive two doses of either Healive® or Avaxim® at 0 and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adult dose, treatment group (≥16 years) | Experimental | Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) |
| Pediatric dose, treatment group (6~ <16 years) | Experimental | Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) |
| Pediatric dose, control group (6~ <16 years) | Active comparator | Biological: Hepatitis A vaccine (inactivated, adsorbed) |
| Pediatric dose, treatment group (1~ <6 years) | Experimental | Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) |
| Pediatric dose, conrol group (1~ <6 years) | Active comparator | Biological: Hepatitis A vaccine (inactivated, adsorbed) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy participants aged 1 year and older;
- Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
- 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.
- Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
- Participants should agree to comply with the lifestyle precautions outlined in the protocol.
Key exclusion criteria (16 listed)
- Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
- Prior history of HAV infection;
- 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;
- Known allergy to vaccines or vaccines ingredients;
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)Also: Healive® (1 mL)Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years) | Biological | Adult dose, treatment group (≥16 years) |
| Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)Also: Healive® (0.5 mL)Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1~<16 years) | Biological | Pediatric dose, treatment group (1~ <6 years), Pediatric dose, treatment group (6~ <16 years) |
| Hepatitis A vaccine (inactivated, adsorbed)Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi | Biological | Pediatric dose, conrol group (1~ <6 years), Pediatric dose, control group (6~ <16 years) |
Primary outcome
Seroconversion rate of anti-HAV antibodies
Time frame: 30 days after the second vaccination
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
6 secondary outcomes
Seropositive rate of anti-HAV antibodies
Time frame: 30 days after the second vaccination
Geometric mean concentration (GMC) of anti-HAV antibodies
Time frame: 30 days after the second vaccination
Geometric mean fold rise (GMFR) of anti-HAV antibodies
Time frame: 30 days after the second vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Time frame: 30 days after each vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Time frame: 7 days after each vaccination
Incidence of serious adverse events (SAE)
Time frame: From first vaccination to 30 days after second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL), Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) and Hepatitis A vaccine (inactivated, adsorbed) in people with Hepatitis A Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Van Anh Thi Pham (84 915595690, phamthivananh.hmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate of anti-HAV antibodies (time frame: 30 days after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.