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Frozen FluMist

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Frozen FluMist · 1 trial · 1 indication

Phase 2 1
NCT00480155A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy AdultsHealthy
COMPLETED300 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults
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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 to 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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Frequently asked questions about Frozen FluMist

What is Frozen FluMist used for?

Frozen FluMist is an investigational monoclonal antibody being studied for use in healthy adults. It is currently in Phase 2 clinical development. The drug is being evaluated for safety in a clinical trial involving healthy volunteers aged 18 years and older.

Who makes Frozen FluMist?

Frozen FluMist is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety of this investigational drug in healthy adult participants.

What phase is Frozen FluMist in?

Frozen FluMist is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 2 clinical trial to evaluate its safety in healthy adults.

What clinical trials is Frozen FluMist in?

Frozen FluMist is being studied in a Phase 2 clinical trial with the identifier NCT00480155. This completed trial, titled 'A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults,' enrolled 300 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is Frozen FluMist FDA approved?

Frozen FluMist is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The drug has completed a Phase 2 clinical trial evaluating its safety in healthy adults, but it has not yet received regulatory approval for any use.