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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02269488 | A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years | PHASE3 | COMPLETED | 100 | — | — | Nov 1, 2014 | Feb 1, 2015 | Sep 28, 2015 | 3 | Japan |
Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number. Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include "Fever ≥ 100.4°F (38.0°C) by any route", "Runny/stuffy nose", "Sore throat", "Cough", "Headache", "Generalized muscle aches", "Decreased activity level (lethargy) or tiredness/weakness", "Decreased appetite" and "Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"
| Arm | Type | Description |
|---|---|---|
| MEDI3250 | EXPERIMENTAL | MEDI3250 Nasal spray |
| Name | Type | Description |
|---|---|---|
| MEDI3250 | DRUG | MEDI3250 |
Inclusion Criteria: 1. Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year. 2. Age 2 through 6 years of age at the time of administration. 3. A written informed consent sh...