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Rochester, New York 14609

  • Influenza

Purpose:

The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: - To describe the safety profile of all subjects in each study group. - To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination. Secondary objectives: - To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine. - To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.


Study summary:

All eligible participants will be randomized to receive a single injection of either one of the high-dose quadrivalent influenza vaccine formulations or one of the high-dose trivalent influenza vaccines at Day 0. They will provide blood samples for hemagglutination inhibition (HAI) testing. Safety information as solicited, unsolicited reactions, serious adverse events, including adverse events of special interest will be collected in the trial.


Criteria:

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 vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 - Vaccination against influenza in the past 6 months - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances - Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed trial - Personal or family history of Guillain-Barré syndrome - Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease free for ≥ 5 years) - Known allergy to iodinated radiocontrast media - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided.


Study is Available At:


Original ID:

QHD01


NCT ID:

NCT02553343


Secondary ID:

U1111-1161-2450


Study Acronym:


Brief Title:

A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older


Official Title:

Safety and Immunogenicity Trial of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

792


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medical Director
Study Director
Sanofi Pasteur Inc.

Study Dates

Start Date:September 2015
Completion Date:April 4, 2016
Completion Type:Actual
Primary Completion Date:April 4, 2016
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 5, 2018
First Received Date:September 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Time Frame:Day 0 up to 6 months post-vaccination
Safety Issues:False
Description: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 collecte
Outcome Type:Primary Outcome
Measure:Hemagglutination inhibition (HAI) antibody titers to influenza virus antigens following vaccination with Fluzone High Dose quadrivalent influenza vaccine or High Dose trivalent influenza vaccine
Time Frame:Day 28 post-vaccination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Time Frame:Day 28 post-vaccination
Safety Issues:False
Description:Seroconversion is defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer at 28 days after vaccination.
Outcome Type:Secondary Outcome
Measure:Seroprotection with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Time Frame:Day 28 post-vaccination
Safety Issues:False
Description:Seroprotection is defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after vaccination.

Study Interventions

Intervention Type:Biological
Name:High-dose quadrivalent influenza virus vaccine
Description:0.5 mL, Intramuscular (IM), injected into the deltoid area
Arm Name:QIV HD1 Group
Other Name:High-dose quadrivalent influenza virus vaccine (QI
Intervention Type:Biological
Name:High-dose influenza virus vaccine
Description:0.5 mL, Intramuscular (IM), injected into the deltoid area
Arm Name:QIV HD2 Group
Other Name:High-dose quadrivalent influenza virus vaccine (QI
Intervention Type:Biological
Name:High-dose trivalent inactivated influenza vaccine
Description:0.5 mL, Intramuscular (IM), injected into the deltoid area
Arm Name:TIV HD1 Group
Other Name:Fluzone® High-Dose, TIV HD1
Intervention Type:Biological
Name:High-dose trivalent inactivated influenza vaccine
Description:0.5 mL, Intramuscular (IM), injected into the deltoid area
Arm Name:TIV HD2 Group
Other Name:TIV HD2

Study Arms

Study Arm Type:Experimental
Arm Name:QIV HD1 Group
Description:Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1)
Study Arm Type:Experimental
Arm Name:QIV HD2 Group
Description:Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2)
Study Arm Type:Active Comparator
Arm Name:TIV HD1 Group
Description:Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine
Study Arm Type:Active Comparator
Arm Name:TIV HD2 Group
Description:Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi Pasteur, a Sanofi Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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