A Phase 3 interventional study of Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) and Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) in Hepatitis A Vaccine, sponsored by Sinovac Biotech Co., Ltd. Recruiting at 1 site in Vietnam. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention
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.
343 studies on the registry are indexed under Hepatitis; 51 are open to participants now.
This study's planned enrollment of 680 is above the median of 85 across 245 interventional studies indexed under Hepatitis.
Browse Hepatitis studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)
Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)
Biological: Hepatitis A vaccine (inactivated, adsorbed)
Biological: Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)
Biological: Hepatitis A vaccine (inactivated, adsorbed)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Also known as: Healive® (1 mL)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)
Also known as: Healive® (0.5 mL)
Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
Seroconversion rate of anti-HAV antibodies
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
Time frame: 30 days after the second vaccination
Seropositive rate of anti-HAV antibodies
The seropositive rate of anti-HAV antibodies 30 days after the second vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days after each vaccination
Incidence of adverse events (AE)/adverse reactions (AR)
Incidence of AE/AR within 7 days after each vaccination
Time frame: 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
Time frame: From first vaccination to 30 days after second vaccination
The seroconversion rate of HAV antibodies
The seroconversion rate of HAV antibodies 30 days after the second vaccination in susceptible population
Time frame: 30 days after the second vaccination
The seropositive rate of anti-HAV antibodies
The seropositive rate of anti-HAV antibodies 30 days after the first vaccination
Time frame: 30 days after the first vaccination
The seroconversion rate of anti-HAV antibodies
The seroconversion rate of anti-HAV antibodies 30 days after the first vaccination
Time frame: 30 days after the first vaccination
The GMC of anti-HAV antibodies
The GMC of anti-HAV antibodies 30 days after the first vaccination
Time frame: 30 days after the first vaccination
The GMFR of anti-HAV antibodies
The GMFR of anti-HAV antibodies 30 days after the first vaccination
Time frame: 30 days after the first vaccination
Plan to share: No
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