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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01636245 | Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine | PHASE3 | COMPLETED | 1,400 | — | — | Jul 1, 2012 | Feb 1, 2013 | Mar 15, 2013 | 1 | China |
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)...