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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03909074 | Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months | PHASE3 | COMPLETED | 900 | — | — | Mar 10, 2019 | Nov 13, 2019 | May 26, 2022 | 1 | China |
Subjects whose pre-immune antibody titer \< 1:8 and post-immune antibody titer ≥ 1:8, or those whose pre-immune antibody titer ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The susceptible population refer to the subjects whose pre-immune antibody titer \<1:8
| Arm | Type | Description |
|---|---|---|
| Experimental group | EXPERIMENTAL | 36-71 months old children-experimental EV71 vaccine. |
| Vaccine-controlled group | ACTIVE_COMPARATOR | 36-71 months old children-control EV71 vaccine. |
| Age-controlled group | ACTIVE_COMPARATOR | 6-35 months old children-experimental EV71 vaccine. |
| Name | Type | Description |
|---|---|---|
| 36-71 months old children-experimental EV71 vaccine. | BIOLOGICAL | Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule. |
| 36-71 months old children-control EV71 vaccine. | BIOLOGICAL | Two doses control EV71 vaccine at the 0, 30 days vaccination schedule. |
| 6-35 months old children-experimental EV71 vaccine. | BIOLOGICAL | Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule. |
Inclusion Criteria: * Healthy volunteers ≥ 2 years old; * Proven legal identity; * Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment. Exclusion Criteria: * Prior vaccination with EV71 vaccin...