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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment680

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated 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
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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
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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
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Recent Changes (Last 90 Days)

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