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AV024

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Nov 20, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

Clinical trial landscape

AV024 · 1 trial · 1 indication

Phase 3 1
NCT00240877Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)Influenza
COMPLETED330 Analytics
PHASE3COMPLETED
Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

- The primary endpoint of this study is fever defined as oral temperature ≥101°F
Days 0-7

Secondary Endpoints

All other reported reactogenicity events and other adverse events.
After 7 days after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMonovalent vaccine prior to the release of the trivalent vaccine (FluMist).
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AV024BIOLOGICAL0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
PlaceboOTHERPlacebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 18-64 years of age (not yet reached their 65th birthday); * In good health; * Available by telephone; * Ability to understand and comply with the requirements of the protocol; and * Signed informed consent. Exclusion Criteria: * Any condition, other than age, for which the i...

Countries:United States
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Frequently asked questions about AV024

What is AV024 used for?

AV024 is a monoclonal antibody being developed for influenza. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied for its safety and efficacy in treating or preventing influenza, a viral infection that affects the respiratory system.

Who makes AV024?

AV024 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of AV024 for the treatment of influenza.

What phase is AV024 in?

AV024 is currently in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The drug is being evaluated in a Phase 3 clinical trial to assess its safety and efficacy in patients with influenza. It is not yet approved by regulatory authorities.

What clinical trials is AV024 in?

AV024 has one completed Phase 3 clinical trial with the identifier NCT00240877. This study evaluated the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults. The trial enrolled 330 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is AV024 FDA approved?

AV024 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The drug is being studied for the treatment of influenza, but it has not yet received regulatory approval. The completed Phase 3 trial evaluated its safety in healthy adults.