Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inactivated Hepatitis A Vaccine · 1 trial · 1 indication
The seroconversion rate of anti-hepatitis A virus (HAV) antibodies 30 days after the second vaccination
| Arm | Type | Description |
|---|---|---|
| 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 | - |
| Name | Type | Description |
|---|---|---|
| Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL) | BIOLOGICAL | Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 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) |
| Hepatitis A vaccine (inactivated, adsorbed) | BIOLOGICAL | Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi |
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...
Inactivated Hepatitis A Vaccine is used to prevent hepatitis A, a viral infection of the liver. It is given as a vaccine in the hepatitis A vaccine category. The formulation described here is an inactivated hepatitis A vaccine (human diploid cell) at 1 mL, developed by Sinovac Biotech, Ltd.
Inactivated Hepatitis A Vaccine is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor of the clinical program for this inactivated hepatitis A vaccine (human diploid cell) 1 mL formulation.
Inactivated Hepatitis A Vaccine is in Phase 3 clinical development. It is an investigational vaccine and is not approved based on the development stage reported here. The Phase 3 program is active, with one recruiting trial and no completed trials.
Inactivated Hepatitis A Vaccine is being studied in one Phase 3 trial, NCT07793227, titled Phase III Clinical Trial of an Inactivated Hepatitis A Vaccine. The trial is recruiting 680 healthy volunteers of all sexes in Vietnam, with a minimum age of 1 year. It is randomized, double blind, and active controlled.