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Also known as EV71 vaccine
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...
The 100U EV71 vaccine with adjuvant is an investigational vaccine developed by Sinovac Biotech for protection against enterovirus 71, a viral infection. It is formulated with an adjuvant and contains 100U of inactivated EV71 antigen. It is given to healthy infants and is designed to prevent enterovirus-related illness.
It is used for the prevention of enterovirus 71 infection, a viral illness that affects infants and young children. The vaccine is intended for healthy volunteers, with trial participants as young as 6 months of age. It targets enterovirus infection in the infectious disease therapeutic area.
Sinovac Biotech, Ltd is developing the 100U EV71 vaccine with adjuvant. The company trades under the ticker SVA. Sinovac conducted the clinical development of this inactivated EV71 vaccine candidate in China.
The 100U EV71 vaccine with adjuvant is in Phase 2 clinical development. It is an investigational vaccine and is not approved for use. One Phase 2 trial has been completed, and no trials are currently active.
The 100U EV71 vaccine with adjuvant was studied in one completed Phase 2 trial, NCT01421121, titled Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants. That trial enrolled 540 healthy infants in China, was randomized, double blind, and placebo controlled, with participants aged 6 months and older.