Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine

NCT07793227 | Recruiting Phase 3

• 1 other identifier: PRO-HAV-4018
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hepatitis A Vaccine

Keywords

Hepatitis A Vaccine; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate of anti-HAV antibodies

  The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination

  30 days after the second vaccination

Secondary Outcomes (6)

• Seropositive rate of anti-HAV antibodies

  30 days after the second vaccination

• Geometric mean concentration (GMC) of anti-HAV antibodies

  30 days after the second vaccination

• Geometric mean fold rise (GMFR) of anti-HAV antibodies

  30 days after the second vaccination

• Incidence of adverse events (AE)/adverse reactions (AR)

  30 days after each vaccination

• Incidence of adverse events (AE)/adverse reactions (AR)

  7 days after each vaccination

Other Outcomes (5)

• The seroconversion rate of HAV antibodies

  30 days after the second vaccination

• The seropositive rate of anti-HAV antibodies

  30 days after the first vaccination

• The seroconversion rate of anti-HAV antibodies

  30 days after the first vaccination

Study Arms (5)

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)

Interventions

Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) BIOLOGICAL

Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)

Also known as: Healive® (1 mL)

Adult dose, treatment group (≥16 years)

Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL) BIOLOGICAL

Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)

Also known as: Healive® (0.5 mL)

Pediatric dose, treatment group (1~ <6 years); Pediatric dose, treatment group (6~ <16 years)

Hepatitis A vaccine (inactivated, adsorbed) BIOLOGICAL

Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi

Pediatric dose, conrol group (1~ <6 years); Pediatric dose, control group (6~ <16 years)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead
• DUC MINH MEDICAL JSC.: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Hepatitis

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Van Anh Thi Pham

CONTACT

84 915595690; phamthivananh.hmu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)