Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01273233 | Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults | PHASE1 | COMPLETED | 36 | — | — | Dec 1, 2010 | Feb 1, 2011 | Mar 15, 2013 | 1 | China |
| 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...