Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vaccine groups
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 three consecutive lots of EV71 vaccine is an investigational inactivated enterovirus type 71 vaccine developed by Sinovac Biotech, Ltd. It is being studied for the prevention of Hand, Foot and Mouth Disease, which is commonly associated with EV71 infection. The vaccine is a Phase 3 candidate tested in a single completed clinical trial.
The three consecutive lots of EV71 vaccine is intended for the prevention of Hand, Foot and Mouth Disease caused by enterovirus type 71. It is an inactivated vaccine candidate evaluated in healthy volunteers, including infants from 6 months of age. The Phase 3 trial enrolled 1,400 participants in China.
Sinovac Biotech, Ltd is developing the three consecutive lots of EV71 vaccine. The company trades under the ticker SVA. Sinovac conducted the Phase 3 study of the vaccine in China, where the trial evaluated immunogenicity and safety in healthy volunteers.
The three consecutive lots of EV71 vaccine is in Phase 3 development. The single registered trial, NCT01636245, has been completed. The vaccine remains an investigational candidate and is not described as approved for marketing in any territory based on the available development information.
The three consecutive lots of EV71 vaccine has been studied in one clinical trial, NCT01636245, titled Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine. The Phase 3 trial was completed, enrolled 1,400 participants in China, and used a randomized, double-blind, placebo-controlled design.