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Monovalent subvirion H5N1 influenza vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment375

FDA Designations

No designations recorded

Clinical trial landscape

Monovalent subvirion H5N1 influenza vaccine · 1 trial · 2 indications

Phase 1 1
NCT00664417Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted VaccineInfluenza
COMPLETED375 Analytics
PHASE1COMPLETED
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the safety after primary administration of A/H1N1 vaccine
6 months post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -
7ACTIVE_COMPARATOR -
8ACTIVE_COMPARATOR -
9PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Monovalent subvirion H5N1 influenza vaccineBIOLOGICAL0.5 mL, IM, 2 injections, Formulation 1
Physiological salineBIOLOGICAL0.5 mL, IM, 2 injections
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria : * Healthy adult aged 18 to 40 years on the day of inclusion. * Provides signed informed consent prior to study procedures. * Able to attend all scheduled visits and comply with all trial procedures. * For a woman of child-bearing potential, avoid becoming pregnant (use of an ef...

Countries:United States
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Frequently asked questions about Monovalent subvirion H5N1 influenza vaccine

What is Monovalent subvirion H5N1 influenza vaccine used for?

Monovalent subvirion H5N1 influenza vaccine is an investigational vaccine being studied for the prevention of influenza, specifically targeting H5N1 avian influenza. It is currently in Phase 1 clinical development and is not yet approved for use.

Who makes Monovalent subvirion H5N1 influenza vaccine?

Monovalent subvirion H5N1 influenza vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is Monovalent subvirion H5N1 influenza vaccine in?

Monovalent subvirion H5N1 influenza vaccine is currently in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 1 trial has been completed to assess its safety and immune response.

What clinical trials is Monovalent subvirion H5N1 influenza vaccine in?

Monovalent subvirion H5N1 influenza vaccine has been studied in one completed Phase 1 clinical trial, registered as NCT00664417. This trial evaluated different formulations of an intramuscular A/H5N1 inactivated, split virion influenza adjuvanted vaccine in 375 healthy adult volunteers in the United States.

Is Monovalent subvirion H5N1 influenza vaccine the same as an adjuvanted H5N1 vaccine?

Monovalent subvirion H5N1 influenza vaccine is being studied in formulations that include an adjuvant. The clinical trial NCT00664417 specifically tested different formulations of an A/H5N1 inactivated, split virion influenza vaccine with adjuvant, indicating that the vaccine is being developed as an adjuvanted formulation.