Recent Updates
Recently added Catalysts

Hepatitis A vaccine

Phase 3

Hepatitis A Vaccine | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Aug 28, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as Hepatitis A vaccine (inactivated, adsorbed)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment680

FDA Designations

No designations recorded

Clinical trial landscape

Hepatitis A vaccine · 1 trial · 1 indication

Phase 3 1
NCT07793227Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A VaccineHepatitis A Vaccine
RECRUITING680 Analytics
PHASE3RECRUITING
Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine
Hepatitis A VaccineUnlock trial analytics

Study Endpoints

Primary Endpoints

Seroconversion rate of anti-HAV antibodies
30 days after the second vaccination

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

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Adult dose, treatment group (≥16 years)EXPERIMENTAL -
Pediatric dose, treatment group (6~ <16 years)EXPERIMENTAL -
Pediatric dose, control group (6~ <16 years)ACTIVE_COMPARATOR -
Pediatric dose, treatment group (1~ <6 years)EXPERIMENTAL -
Pediatric dose, conrol group (1~ <6 years)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)BIOLOGICALInactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)BIOLOGICALInactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)
Hepatitis A vaccine (inactivated, adsorbed)BIOLOGICALHepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
Unlock Study Design Details

Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Vietnam
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07793227NEW_TRIAL: changed
LOWAug 28, 2026NCT07793227NEW_TRIAL: changed

Frequently asked questions about Hepatitis A vaccine

What is Hepatitis A vaccine used for?

Hepatitis A vaccine is used for the prevention of Hepatitis A infection. It is an inactivated, adsorbed vaccine being developed for use in individuals as young as 1 year old. The vaccine is intended to stimulate the immune system to produce protection against the Hepatitis A virus.

Who makes Hepatitis A vaccine?

Hepatitis A vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is conducting a Phase 3 clinical trial for this vaccine candidate. Sinovac Biotech is listed on the stock exchange under the ticker symbol SVA.

What phase is Hepatitis A vaccine in?

Hepatitis A vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use. The Phase 3 trial is actively recruiting participants to evaluate the vaccine's safety and efficacy in preventing Hepatitis A.

What clinical trials is Hepatitis A vaccine in?

Hepatitis A vaccine is being studied in a Phase 3 clinical trial with the identifier NCT07793227. This trial is titled 'Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine' and is currently recruiting participants in Vietnam. The study is randomized, double-blind, and active-controlled, with an enrollment target of 680 participants.

Is Hepatitis A vaccine the same as Hepatitis A vaccine (inactivated, adsorbed)?

Yes, Hepatitis A vaccine is also known as Hepatitis A vaccine (inactivated, adsorbed). This alternative name describes the vaccine's formulation, which contains inactivated Hepatitis A virus particles that are adsorbed to an adjuvant to enhance the immune response.