A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
NCT ID: NCT02553343
Last Updated: 2018-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
792 participants
INTERVENTIONAL
2015-09-30
2016-04-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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QIV HD1 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1)
High-dose quadrivalent influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
QIV HD2 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2)
High-dose influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
TIV HD1 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine
High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
TIV HD2 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine
High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Interventions
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High-dose quadrivalent influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
High-dose influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Milford, Connecticut, United States
Coral Gables, Florida, United States
Wichita, Kansas, United States
St Louis, Missouri, United States
Rochester, New York, United States
Warwick, Rhode Island, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1161-2450
Identifier Type: OTHER
Identifier Source: secondary_id
QHD01
Identifier Type: -
Identifier Source: org_study_id
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