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Also known as EV71 vaccine
100U inactivated Enterovirus Type 71 Vaccine · 1 trial · 2 indications
All adverse events were records. Blood cell and biochemistry were performed.
| Arm | Type | Description |
|---|---|---|
| Children Group 1: 200U EV71 vaccine | EXPERIMENTAL | 12 children received 3 doses of 200U EV71 vaccine 28 days apart |
| Children Group 1: Placebo | PLACEBO_COMPARATOR | 6 children received 3 doses of placebo 28 days apart |
| Children Group 2: 400U EV71 vaccine | EXPERIMENTAL | 12 children received 3 doses of 400U EV71 vaccine 28 days apart |
| Children Group 2: Placebo | PLACEBO_COMPARATOR | 6 children received 3 doses of placebo 28 days apart |
| Infants Group 1: 100U EV71 vaccine | EXPERIMENTAL | 24 infants received 3 doses of 100U EV71 vaccine 28 days apart |
| Infants Group 1: Placebo | PLACEBO_COMPARATOR | 8 infants received 3 doses of placebo 28 days apart |
| Infants Group 2: 200U EV71 vaccine | EXPERIMENTAL | 24 infants received 3 doses of 200U EV71 vaccine 28 days apart |
| Infants Group 2: Placebo | PLACEBO_COMPARATOR | 8 infants received 3 doses of placebo 28 days apart |
| Infants Group 3: 400U EV71 vaccine | EXPERIMENTAL | 24 infants received 3 doses of 400U EV71 vaccine 28 days apart |
| Infants Group 3: Placebo | PLACEBO_COMPARATOR | 8 infants received 3 doses of placebo 28 days apart |
| Name | Type | Description |
|---|---|---|
| 100U inactivated Enterovirus Type 71 Vaccine | BIOLOGICAL | Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
| 200U inactivated Enterovirus Type 71 Vaccine | BIOLOGICAL | Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
| 400U inactivated Enterovirus Type 71 Vaccine | BIOLOGICAL | Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
| Placebo | BIOLOGICAL | Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
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 inactivated Enterovirus Type 71 Vaccine is an investigational vaccine developed by Sinovac Biotech, Ltd for hand-foot-mouth disease, an infectious disease caused by enterovirus type 71. It is a vaccine modality given to healthy children, and it is not an approved product; it remains in clinical development.
It is being developed for hand-foot-mouth disease, which is associated with enterovirus type 71 infection. The vaccine is intended for use in healthy children, with trial eligibility starting at 6 months of age. It is investigational and has not been established as a marketed treatment or preventive product.
Sinovac Biotech, Ltd, which trades under the ticker SVA, is the developer of 100U inactivated Enterovirus Type 71 Vaccine. The company ran the clinical program for this vaccine candidate in China, where the single reported trial was conducted.
100U inactivated Enterovirus Type 71 Vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The vaccine is investigational and has not been approved by the FDA or any other regulator based on the available information.
The vaccine was studied in one completed Phase 1 trial, NCT01273246, titled Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children. That trial enrolled 132 healthy children in China, was randomized, double blind, and placebo controlled, and included participants of all sexes from 6 months of age.