Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01273246 | Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children | PHASE1 | COMPLETED | 132 | — | — | Jan 1, 2011 | Jul 1, 2011 | Jul 28, 2021 | 1 | China |
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...