Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 36-71 months old children-experimental EV71 vaccine.
36-71 months old children-experimental EV71 vaccine · 1 trial · 1 indication
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...