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Monovalent subvirion H5N1 influenza vaccine

Phase 1

Influenza | Vaccine | Infectious Disease |Sanofi|Trials Updated: Apr 17, 2012

Monovalent subvirion H5N1 influenza vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2008

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

Monovalent subvirion H5N1 influenza vaccine clinical trials

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 the monovalent subvirion H5N1 influenza vaccine?

The monovalent subvirion H5N1 influenza vaccine is an investigational vaccine developed by Sanofi that targets the H5N1 strain of influenza. It is a split virion, inactivated vaccine designed for intramuscular administration. It is intended to protect against H5N1 influenza virus infection and has been studied in healthy adult volunteers.

Who makes the monovalent subvirion H5N1 influenza vaccine?

Sanofi, which trades under the ticker SNY, is the developer of the monovalent subvirion H5N1 influenza vaccine. Sanofi conducted the clinical development of this vaccine candidate. The company is a global pharmaceutical and vaccine manufacturer.

What phase is the monovalent subvirion H5N1 influenza vaccine in?

The monovalent subvirion H5N1 influenza vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials are currently listed for this vaccine candidate.

What clinical trials is the monovalent subvirion H5N1 influenza vaccine in?

The monovalent subvirion H5N1 influenza vaccine was studied in a completed Phase 1 trial, NCT00664417, titled "Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine." The trial enrolled 375 participants in the United States, was randomized and placebo-controlled, and included healthy volunteers aged 18 years and older.

What is the monovalent subvirion H5N1 influenza vaccine used for?

The monovalent subvirion H5N1 influenza vaccine is being developed for the prevention of influenza caused by the H5N1 virus. It is intended for use in healthy adult volunteers. The vaccine targets Orthomyxoviridae infections, the family of viruses that includes influenza.