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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...
It is an experimental enterovirus 71 (EV71) inactivated vaccine developed for children aged 36 to 71 months. It is intended to prevent Hand, Foot and Mouth Disease, which is commonly caused by EV71. The vaccine is in Phase 3 clinical development and is not yet approved.
It is used for the prevention of Hand, Foot and Mouth Disease in children aged 36 to 71 months. Hand, Foot and Mouth Disease is a common viral illness that can be caused by enterovirus 71. The vaccine is designed to stimulate immunity against EV71.
Sinovac Biotech, Ltd is developing the 36-71 months old children-experimental EV71 vaccine. Sinovac Biotech trades under the ticker SVA. The company is responsible for the clinical development of this EV71 vaccine candidate.
The 36-71 months old children-experimental EV71 vaccine is in Phase 3 clinical development. A Phase 3 trial has been completed, but the vaccine is not approved and remains investigational. No active trials are currently listed for this vaccine candidate.
The vaccine has been studied in one completed Phase 3 clinical trial, NCT03909074, titled Clinical Trial of Enterovirus 71 (EV71) Inactivated Vaccine in Children Aged 36-71 Months. The trial enrolled 900 participants in China and was randomized, double-blind, and active-controlled.
The 36-71 months old children-experimental EV71 vaccine is also known by that same descriptive name. It is a specific EV71 vaccine candidate developed by Sinovac Biotech for children aged 36 to 71 months, and it should not be confused with other EV71 vaccines from different manufacturers.