Approval Probability
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Adjusted LOA
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400U/ EV71 vaccine · 1 trial · 1 indication
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
| Arm | Type | Description |
|---|---|---|
| 400U /0.5ml in infants | EXPERIMENTAL | inactivated vaccine(vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28 |
| 0/0.5ml placebo in infants | PLACEBO_COMPARATOR | 0/0.5ml placebo in 5000 infants aged 6-35 months old on day0,28 |
| Name | Type | Description |
|---|---|---|
| 400U /0.5ml EV71 vaccine | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval |
| 0/0.5ml placebo | BIOLOGICAL | 0/0.5ml placebo, two doses, 28 days interval |
Inclusion Criteria: * Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator * Provided legal identification for the sake of recruitment * Subjects and/or parent(s)...
400U/ EV71 vaccine is used for the prevention of Hand, Foot and Mouth Disease. It is an investigational vaccine developed by Sinovac Biotech, Ltd (SVA). The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
400U/ EV71 vaccine targets the Enterovirus type 71 (EV71), which is a major cause of Hand, Foot and Mouth Disease. The vaccine is designed to elicit an immune response against this virus, potentially reducing the incidence of the disease.
400U/ EV71 vaccine is developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker SVA. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for the prevention of Hand, Foot and Mouth Disease.
400U/ EV71 vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 3 trial has been completed, with results expected to support potential future registration and licensure.
400U/ EV71 vaccine has been studied in one Phase 3 clinical trial, identified as NCT01507857. This randomized, double-blind, placebo-controlled trial enrolled 10,077 participants in China to evaluate the vaccine's efficacy in preventing Hand, Foot and Mouth Disease. The trial has been completed.
400U/ EV71 vaccine is a specific formulation of the EV71 vaccine, with the dosage strength indicated as 400U. It is designed to protect against Enterovirus type 71, a cause of Hand, Foot and Mouth Disease. The vaccine is being developed by Sinovac Biotech, Ltd.