Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
100U EV71 vaccine with adjuvant · 1 trial · 1 indication
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8
| Arm | Type | Description |
|---|---|---|
| 100U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200 U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 400U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200U EV71 vaccine without adjuvant | EXPERIMENTAL | 60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart |
| Placebo | PLACEBO_COMPARATOR | 120 infants received 2 doses of placebo 28 days apart. |
| Name | Type | Description |
|---|---|---|
| 100U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval |
| 200 U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval |
| 400U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval |
| 200U EV71 vaccine without adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval |
| Placebo | BIOLOGICAL | 0.5ml placebo, two doses, 28 days interval |
Inclusion Criteria: 1. 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 2. Provided legal identification for the sake of recruitment. 3. Subjects and/or paren...
100U EV71 vaccine with adjuvant is an investigational vaccine being studied for the prevention of enterovirus infection, specifically targeting Enterovirus 71 (EV71), which can cause hand, foot, and mouth disease. It is intended for use in infants, as the clinical trial enrolled participants as young as 6 months of age.
100U EV71 vaccine with adjuvant is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker symbol SVA. The company is conducting clinical research on this vaccine candidate for the prevention of enterovirus infection.
100U EV71 vaccine with adjuvant is in Phase 2 clinical development. It is an investigational vaccine and has not been approved for commercial use. The Phase 2 trial has been completed, and the vaccine remains under clinical investigation for its safety and immunogenicity profile.
100U EV71 vaccine with adjuvant has been studied in one completed Phase 2 clinical trial with the identifier NCT01421121. The trial, titled 'Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants,' was conducted in China and enrolled 540 healthy infant participants aged 6 months and older.
Despite being classified as a monoclonal antibody modality in some databases, 100U EV71 vaccine with adjuvant is described in the clinical trial as an inactivated EV71 vaccine. The trial title refers to it as an inactivated vaccine, indicating it is a vaccine candidate rather than a therapeutic monoclonal antibody.