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FluMist

Phase 3

Healthy | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Jul 18, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment600
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325481Study To Evaluate the Safety of Bivalent VaccinePHASE3 COMPLETED 300 — — Jun 1, 2006Dec 1, 2006Jul 18, 20073 United States
NCT00125944Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy AdultsPHASE3 COMPLETED 300 — — Jul 1, 2005Jan 1, 2006May 9, 20074 United States
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Study Endpoints
Primary Endpoints
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least 101°F.
The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F.
Secondary Endpoints
Secondary endpoints of the study include other reported REs and AEs that occur within 7 days after vaccination (Study Days 0-7) and all REs and AEs that occur within 14 days after vaccination (Study Days 0-14).
Reported Reactogenocity Events (REs) and Adverse Events (AEs) that occur within 7 days after vaccination and that occur within 14 days after vaccination. SAEs and SNMCs that occur within 28 days after vaccination and within 180 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
FluMistDRUG -
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 ...

Countries:United States
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