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Frozen FluMist

Phase 2

Healthy | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Dec 22, 2008

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00480155A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy AdultsPHASE2 COMPLETED 300 — — May 1, 2007Dec 1, 2007Dec 22, 20083 United States
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Study Endpoints
Primary Endpoints
The primary endpoint of this study is fever ≥101°F.
Study Days 0-7
Secondary Endpoints
Secondary outcome measures of the study include other reported SEs and AEs that occur within 7 days after vaccination (Study Days 0-7) and all SEs and AEs that occur within 14 days after vaccination (Study Days 0-14).
Study days 0-7 after vaccination; Study days 0-14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORFluMist
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Frozen FluMist®BIOLOGICALMonovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
PlaceboOTHER -
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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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