Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EV71 Vaccine
Inactivated Enterovirus Type 71 Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1: 200U EV71 vaccine | EXPERIMENTAL | 12 adults received 3 doses of 200U EV71 vaccine 14 days apart |
| Group 2: 400U EV71 vaccine | EXPERIMENTAL | 12 adults received 3 doses of 400U EV71 vaccine 14 days apart |
| Group 1: Placebo | PLACEBO_COMPARATOR | 6 adults received 3 doses of placebo 14 days apart |
| Group 2: Placebo | PLACEBO_COMPARATOR | 6 adults received 3 doses of placebo 14 days apart |
| Name | Type | Description |
|---|---|---|
| Inactivated Enterovirus Type 71 Vaccine | BIOLOGICAL | A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit) |
| Placebo | OTHER | Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents. |
Inclusion Criteria: 1. Healthy males and females, aged from 18 to 49 years old. Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. Provided legal identification for the sake of recruitment. 3. Subjects are able to under...
The Inactivated Enterovirus Type 71 Vaccine is an investigational vaccine developed by Sinovac Biotech, Ltd for protection against enterovirus type 71 infection. It uses inactivated virus to stimulate an immune response. It is in Phase 1 clinical development and has been studied in healthy adult volunteers in China.
It is being developed to prevent infection caused by enterovirus type 71, a viral pathogen. The Phase 1 trial enrolled healthy adults rather than patients with active disease, which is typical for preventive vaccine studies. The vaccine is not approved and remains investigational.
Sinovac Biotech, Ltd, which trades under the ticker SVA, is the developer of the Inactivated Enterovirus Type 71 Vaccine. The company ran the Phase 1 study in China.
The Inactivated Enterovirus Type 71 Vaccine is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved for use.
The Inactivated Enterovirus Type 71 Vaccine has been studied in one completed Phase 1 trial, NCT01273233, titled Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults. It was randomized, double blind, and placebo controlled, enrolling 36 healthy adults aged 18 years and older in China.