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Fluzone: Influenza virus vaccine

Phase 2

Influenza | Vaccine | Infectious Disease |Sanofi|Last Updated: Apr 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

Fluzone: Influenza virus vaccine · 1 trial · 1 indication

Phase 2 1
NCT00623181Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy AdultsInfluenza
COMPLETED110 Analytics
PHASE2COMPLETED
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Day 0 and up to 7 days post-vaccination

Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.

Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Days 0, 3, and 7 after vaccination

Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Fluzone Intradermal First, Then Fluzone IntramuscularEXPERIMENTAL -
Fluzone Intramuscular First, Then Fluzone IntradermalEXPERIMENTAL -

Interventions

NameTypeDescription
Fluzone: Influenza virus vaccineBIOLOGICAL0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to \< 50 years of age on the day of inclusion. * Informed consent form signed. * Able to attend both scheduled visits and to comply with all trial pr...

Countries:United States
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Frequently asked questions about Fluzone: Influenza virus vaccine

What is Fluzone used for?

Fluzone is an influenza virus vaccine developed by Sanofi for the prevention of influenza. It is intended to protect against influenza infection, and clinical development has focused on evaluating different routes of administration in healthy adults.

Who makes Fluzone?

Fluzone is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer of this influenza virus vaccine and conducted the clinical study evaluating its use.

What phase is Fluzone in?

Fluzone has been studied in Phase 2 clinical development for influenza. The completed trial was a Phase 2 study, and there are no active trials listed for this vaccine candidate.

What clinical trials is Fluzone in?

Fluzone was evaluated in a completed Phase 2 trial, NCT00623181, titled a study to determine a preference for Fluzone vaccine given intradermally and intramuscularly in healthy adults. The trial enrolled 110 participants in the United States and was controlled and randomized.

How was Fluzone administered in its clinical trial?

In the completed Phase 2 trial NCT00623181, Fluzone was given both intradermally and intramuscularly to healthy adults to determine a preference between the two routes. The study enrolled 110 participants aged 18 years and older in the United States.