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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 an inactivated enterovirus type 71 (EV71) vaccine developed by Sinovac Biotech, Ltd for the prevention of Hand, Foot and Mouth Disease. It is a vaccine candidate that has completed a Phase 3 clinical trial in China.
400U/ EV71 vaccine is intended for the prevention of Hand, Foot and Mouth Disease, which is a common childhood illness often caused by enterovirus type 71. The vaccine is designed to protect against EV71 infection, a major cause of severe cases of the disease.
400U/ EV71 vaccine is developed by Sinovac Biotech, Ltd, a biopharmaceutical company whose common stock trades under the ticker symbol SVA. Sinovac is based in China and focuses on vaccines for infectious diseases.
400U/ EV71 vaccine has completed a Phase 3 clinical trial. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial, NCT01507857, was a randomized, double-blind, placebo-controlled study conducted in China.
400U/ EV71 vaccine has been evaluated in one clinical trial: NCT01507857, titled "An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine." This Phase 3 trial is completed and enrolled 10,077 healthy volunteers aged 6 months and older in China.