Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
36-71 months old children-control 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...
36-71 months old children-control EV71 vaccine is an investigational vaccine being studied for the prevention of Hand, Foot and Mouth Disease. It is designed for use in children aged 36 to 71 months. The vaccine is currently in Phase 3 clinical development and is not yet approved for use.
36-71 months old children-control EV71 vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing Hand, Foot and Mouth Disease in children.
36-71 months old children-control EV71 vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to support potential future regulatory submissions.
36-71 months old children-control EV71 vaccine has one completed Phase 3 clinical trial, identified as NCT03909074. This trial enrolled 900 participants in China and evaluated the vaccine in children aged 36 to 71 months for the prevention of Hand, Foot and Mouth Disease.
36-71 months old children-control EV71 vaccine is not FDA approved. It is an investigational vaccine currently in Phase 3 clinical development. The completed Phase 3 trial, NCT03909074, was conducted in China, and the vaccine has not yet received approval from the U.S. Food and Drug Administration.