Recruiting

Immunogenicity and Safety Evaluation of Inactivated Hepatitis A Vaccine in Healthy Adults and Children

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Study Aim

This study aims to evaluate the safety and effectiveness of an inactivated Hepatitis A vaccine in healthy adults and children, by measuring the seroconversion rate of anti-Hepatitis A virus antibodies 30 days after the second vaccination.

What is being tested

Hepatitis A Vaccine for Adults

+ Hepatitis A Vaccine for Children

+ Sanofi's Hepatitis A Vaccine Study

Biological
Who is being recruted

Digestive System Diseases

+ Liver Diseases

+ Hepatitis

Over 1 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: August 2026
See protocol details

Summary

Principal SponsorSinovac Biotech Co., Ltd
Study ContactVan Anh Thi PhamMore contacts
Last updated: August 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2026

Actual date on which the first participant was enrolled.

This clinical trial is all about evaluating the safety and effectiveness of a vaccine called Healive®, which is designed to prevent hepatitis A in healthy adults and children aged 1 year and older. The study is particularly interested in understanding how well the vaccine works in two different age groups: adults (16 years and above) and children (1 to less than 16 years). The importance of this study lies in its potential to provide a reliable solution for preventing hepatitis A, a contagious liver disease, in a broad age range. The trial involves 680 participants in total. Adults will receive a 1 mL dose of Healive®, while children will receive either a 0.5 mL dose of Healive® or a comparable vaccine, Avaxim®. Participants in the children's group will be randomly assigned to receive one of these two vaccines. Everyone involved will receive two doses of their assigned vaccine, six months apart. The study's primary focus is to measure the percentage of participants who develop protective antibodies against hepatitis A 30 days after their second vaccination. This helps researchers understand how well the vaccine prompts the body's immune response.

Principal SponsorSinovac Biotech Co., Ltd
Study ContactVan Anh Thi PhamMore contacts
Last updated: August 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

680 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 1 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesHepatitis

Criteria

5 inclusion criteria required to participate
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 agree to comply with the lifestyle precautions outlined in the protocol

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16 exclusion criteria prevent from participating
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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive the Inactivated Hepatitis A Vaccine (Human Diploid Cell), manufactured by Sinovac. This is the adult dose for individuals aged 16 years and older.

Group II

Experimental
Participants in this group receive the Hepatitis A Vaccine, specifically designed for children aged 6 to under 16. This vaccine is produced by Sinovac.

Group III

Active Comparator
This group is for children aged 6 to under 16 years. They receive the Hepatitis A vaccine (inactivated, adsorbed) made by Sanofi.

Group IV

Experimental
Participants in this group will receive the Hepatitis A Vaccine, specifically designed for children aged between 1 and 6 years. The vaccine is manufactured by Sinovac.

Group 5

Active Comparator
This group receives the Hepatitis A vaccine, which is an active vaccine manufactured by Sanofi. It's designed for children aged between 1 and less than 6 years.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hanoi Medical University

Hanoi, VietnamOpen Hanoi Medical University in Google Maps
Recruiting
One Study Center