Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI3250 · 2 trials · 2 indications
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"
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)
| Arm | Type | Description |
|---|---|---|
| MEDI3250 | EXPERIMENTAL | MEDI3250 Nasal spray |
| Placebo | PLACEBO_COMPARATOR | Placebo Nasal spray |
| Name | Type | Description |
|---|---|---|
| MEDI3250 | DRUG | MEDI3250 |
| Placebo | DRUG | Placebo |
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...
MEDI3250 is an investigational small molecule being studied for use in healthy Japanese children. It is being evaluated in two age groups: children aged 2 through 6 years and children aged 7 through 18 years. The drug is being developed by AstraZeneca PLC and is currently in Phase 3 clinical development.
MEDI3250 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 3 clinical trials for use in healthy Japanese children aged 2 through 18 years.
MEDI3250 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, one in healthy Japanese children aged 7 through 18 years and another in healthy Japanese children aged 2 through 6 years.
MEDI3250 has been studied in two completed Phase 3 clinical trials. The first, NCT02269475, evaluated the efficacy and safety of MEDI3250 in healthy Japanese children aged 7 through 18 years with 1369 participants. The second, NCT02269488, was an open-label safety study in healthy Japanese children aged 2 through 6 years with 100 participants.
MEDI3250 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed trials were conducted in Japan and focused on healthy Japanese children, but the drug has not received approval from the U.S. Food and Drug Administration or any other regulatory authority.