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High-dose quadrivalent influenza virus vaccine

Phase 2

Influenza | Vaccine | Infectious Disease |Sanofi|Trials Updated: Feb 9, 2018

High-dose quadrivalent influenza virus vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2015

High-dose quadrivalent influenza virus vaccine target and mechanism

ModalityVaccine

Also known as Quadrivalent Influenza Virus Vaccine, High-dose quadrivalent influenza virus vaccine (QIV HD1)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment792

FDA Designations

No designations recorded

High-dose quadrivalent influenza virus vaccine clinical trials

High-dose quadrivalent influenza virus vaccine · 1 trial · 1 indication

Phase 2 1
NCT02553343A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and OlderInfluenza
COMPLETED792 Analytics
PHASE2COMPLETED
A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants reporting solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination with a dose of Fluzone influenza vaccines
Day 0 up to 6 months post-vaccination

Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected

Hemagglutination inhibition (HAI) antibody titers to influenza virus antigens following vaccination with Fluzone High Dose quadrivalent influenza vaccine or High Dose trivalent influenza vaccine
Day 28 post-vaccination

Secondary Endpoints

Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Day 28 post-vaccination
Seroprotection with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Day 28 post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
QIV HD1 GroupEXPERIMENTALAdults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1)
QIV HD2 GroupEXPERIMENTALAdults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2)
TIV HD1 GroupACTIVE_COMPARATORAdults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine
TIV HD2 GroupACTIVE_COMPARATORAdults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine

Interventions

NameTypeDescription
High-dose quadrivalent influenza virus vaccineBIOLOGICAL0.5 mL, Intramuscular (IM), injected into the deltoid area
High-dose influenza virus vaccineBIOLOGICAL0.5 mL, Intramuscular (IM), injected into the deltoid area
High-dose trivalent inactivated influenza vaccineBIOLOGICAL0.5 mL, Intramuscular (IM), injected into the deltoid area
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * Aged ≥ 65 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participation at the time of trial enrollment (or in the 4 weeks preceding the trial...

Countries:United States
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Frequently asked questions about High-dose quadrivalent influenza virus vaccine

What is the high-dose quadrivalent influenza virus vaccine?

The high-dose quadrivalent influenza virus vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It is designed to provide protection against four influenza virus strains and is being studied in adults aged 65 years and older. It is also known as the Quadrivalent Influenza Virus Vaccine.

What is the high-dose quadrivalent influenza virus vaccine used for?

The high-dose quadrivalent influenza virus vaccine is intended for the prevention of influenza in adults aged 65 years and older. It targets four influenza virus strains. The vaccine is investigational and has been studied in a Phase 2 clinical trial.

Who makes the high-dose quadrivalent influenza virus vaccine?

The high-dose quadrivalent influenza virus vaccine is developed by Sanofi, which trades on the New York Stock Exchange under the ticker symbol SNY. Sanofi is a global pharmaceutical company with a portfolio that includes vaccines.

What phase is the high-dose quadrivalent influenza virus vaccine in?

The high-dose quadrivalent influenza virus vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial has been completed.

What clinical trials is the high-dose quadrivalent influenza virus vaccine in?

The high-dose quadrivalent influenza virus vaccine has been studied in one clinical trial, NCT02553343, titled "A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older." This Phase 2 trial was completed and enrolled 792 participants in the United States.

Is the high-dose quadrivalent influenza virus vaccine the same as the Quadrivalent Influenza Virus Vaccine?

Yes, the high-dose quadrivalent influenza virus vaccine is also known as the Quadrivalent Influenza Virus Vaccine. Both names refer to the same Sanofi investigational vaccine for influenza.