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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02964065 | A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV) | PHASE3 | COMPLETED | 9,000 | — | — | Nov 1, 2016 | - | Sep 14, 2017 | 3 | China |
| Arm | Type | Description |
|---|---|---|
| LAIV | EXPERIMENTAL | a single dose of Live-Attenuated influenza Vaccine;Dose: 0.2 ml; Each dose contains not less than 6.9 lg EID50 of type A live attenuated influenza virus reassortants(H1N1 and H3N2), and not less than 6.4 lg EID50 of type B live attenuated influenza virus reassortants. |
| Placebo | PLACEBO_COMPARATOR | a single dose of Placebo. Inactivated placebo will be identical to LAIV in appearance, ingredients and concentrations, attenuated influenza virus free. |
| Name | Type | Description |
|---|---|---|
| Live-Attenuated influenza Vaccine(LAIV) | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy children and adolescents aged 3-17 years old. 2. Informed consent obtained and signed by subjects or legal guardians prior to screening. Children or adolescents aged 10-17 yrs need sign informed consent by themselves. 3. Willing to participate for the planned duration...