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 developed by AstraZeneca PLC. It has been studied in Phase 3 clinical trials in healthy Japanese children, with two completed trials enrolling a total of 1,469 participants. The specific therapeutic indication for MEDI3250 has not been publicly disclosed.
MEDI3250 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical development program for this small molecule candidate.
MEDI3250 has completed Phase 3 clinical development. Two Phase 3 trials have been completed, and there are currently no active trials listed for this candidate. It is an investigational agent and is not described as approved by the FDA.
MEDI3250 has been evaluated in two completed Phase 3 trials. NCT02269488 was an open-label safety study in healthy Japanese children aged 2 through 6 years, enrolling 100 participants. NCT02269475 was a Phase 3 efficacy and safety study in healthy Japanese children aged 7 through 18 years, enrolling 1,369 participants.
Both Phase 3 trials of MEDI3250 were conducted in Japan in healthy Japanese children. NCT02269475 was randomized, double-blind, and placebo-controlled, enrolling 1,369 children aged 7 through 18 years. NCT02269488 was an open-label safety study enrolling 100 children aged 2 through 6 years.