Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FluMist · 5 trials · 3 indications
Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.
An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | FluMist |
| 2 | PLACEBO_COMPARATOR | Placebo |
| 3 | PLACEBO_COMPARATOR | Placebo |
| FluMist | ACTIVE_COMPARATOR | The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like. |
| Placebo | PLACEBO_COMPARATOR | Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| Name | Type | Description |
|---|---|---|
| FluMist | DRUG | - |
| Placebo | OTHER | A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0 |
Inclusion Criteria: * Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination * Healthy by medical history and health assessment * Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective ...
FluMist is an investigational live attenuated influenza vaccine administered as a nasal spray, being studied for the prevention of influenza in healthy adults and children. It is also noted in development contexts involving cancer and healthy volunteer populations, though its primary focus is influenza prevention.
FluMist is developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. AstraZeneca is responsible for the clinical development and manufacturing of this influenza vaccine candidate.
FluMist is in Phase 1 clinical development, although its completed trials were conducted in Phase 3. The drug remains investigational and has not been approved by regulatory authorities. It is still undergoing clinical evaluation to assess its safety and efficacy.
FluMist has been evaluated in completed trials including NCT00125944, NCT00192127, NCT00192491, and NCT00325481. These studies assessed the safety and immunogenicity of the vaccine in healthy adults and children, with enrollments ranging from 300 to 1200 participants.
FluMist is a live cold-adapted influenza vaccine that has been studied in trivalent formulations. In clinical trials, it was administered concurrently with measles, mumps, rubella, and varicella vaccines to healthy children, indicating its compatibility with routine pediatric vaccinations.