Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the prevention of hand-foot-mouth disease, a viral infection caused by enteroviruses. It is designed for use in healthy children and is currently in clinical development.
100U inactivated Enterovirus Type 71 Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the stock exchange under the ticker symbol SVA. The company is conducting clinical trials to evaluate the vaccine's safety in healthy children.
100U inactivated Enterovirus Type 71 Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under evaluation for safety.
100U inactivated Enterovirus Type 71 Vaccine has been studied in one clinical trial, identified as NCT01273246, titled 'Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children.' This Phase 1 trial was completed and enrolled 132 participants in China.
100U inactivated Enterovirus Type 71 Vaccine is a specific formulation of an inactivated enterovirus type 71 vaccine. It is being developed to protect against hand-foot-mouth disease caused by enterovirus type 71. No alternative names for this vaccine have been disclosed.