Approval Probability
TA Base Rate
Adjusted LOA
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three consecutive lots of EV71 vaccine · 1 trial · 1 indication
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
| Arm | Type | Description |
|---|---|---|
| Lot 1 | EXPERIMENTAL | inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Lot 2 | EXPERIMENTAL | inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Lot 3 | EXPERIMENTAL | inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Placebo | PLACEBO_COMPARATOR | Placebo in 350 infants aged 6 months to 5 years old on day 0,28 |
| Name | Type | Description |
|---|---|---|
| three consecutive lots of EV71 vaccine | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval |
| placebo | BIOLOGICAL | 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)...
The EV71 vaccine is used for the prevention of Hand, Foot and Mouth Disease. It is an inactivated enterovirus type 71 vaccine being developed by Sinovac Biotech, Ltd. The vaccine is intended for use in children as young as 6 months of age.
The EV71 vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company conducted a Phase 3 clinical trial of the vaccine in China. Sinovac Biotech is focused on the research, development, and commercialization of vaccines for infectious diseases.
The EV71 vaccine has completed a Phase 3 clinical trial. The trial, which was randomized, double-blind, and placebo-controlled, enrolled 1,400 participants. The vaccine is investigational and has not been approved for commercial use based on the available information.
The EV71 vaccine was studied in a Phase 3 clinical trial with the identifier NCT01636245. The trial, titled 'Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine', was conducted in China and has been completed. It enrolled 1,400 healthy volunteers aged 6 months and older.
Yes, the EV71 vaccine is an inactivated enterovirus type 71 vaccine. It is designed to protect against Hand, Foot and Mouth Disease caused by the enterovirus 71. The vaccine was tested in three consecutive lots to assess its immunogenicity and safety in a Phase 3 trial.