Recent Updates
Recently added Catalysts

Frozen FluMist

Phase 2

Undisclosed | Monoclonal antibody | Other |AstraZeneca PLC|Trials Updated: Dec 22, 2008

Frozen FluMist development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Frozen FluMist clinical trials

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
HealthyUnlock trial analytics

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
Unlock Study Endpoints

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 -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Frozen FluMist

What is Frozen FluMist?

Frozen FluMist is an investigational monoclonal antibody developed by AstraZeneca PLC. It has been studied in a Phase 2 clinical trial in healthy adult volunteers. The specific medical conditions it is intended to treat have not been disclosed. It is not yet approved for any use.

Who is developing Frozen FluMist?

Frozen FluMist is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker symbol AZN. AstraZeneca is the sponsor of the clinical program for this monoclonal antibody candidate.

What phase is Frozen FluMist in?

Frozen FluMist is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is Frozen FluMist in?

Frozen FluMist has been evaluated in one completed Phase 2 trial, NCT00480155, titled A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults. The trial enrolled 300 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

Is Frozen FluMist the same as Frozen FluMist®?

Yes, Frozen FluMist and Frozen FluMist® refer to the same investigational monoclonal antibody developed by AstraZeneca PLC. The registered trademark symbol is simply a notation of the brand name and does not indicate a different product or formulation.