Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
NCT ID: NCT01712984
Last Updated: 2015-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3360 participants
INTERVENTIONAL
2012-10-31
2013-10-31
Brief Summary
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Primary Objective:
* To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination.
Secondary Objectives:
* To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain.
* To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.
* To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status.
* To describe the safety profile for subjects who receive QIV-ID and TIV-ID.
Observational Objectives:
* To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined
* To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
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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 ID Vaccine Group
Participants will receive the intradermal quadrivalent influenza vaccine
Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
0.1mL, Intradermal
TIV ID1 Vaccine Group
Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage
Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
0.1mL, Intradermal
TIV ID2 Group
Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage
Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
0.1mL, Intradermal
Interventions
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Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
0.1mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
0.1mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
0.1mL, Intradermal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form (ICF) has been signed and dated
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 preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination
* 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
* History of thrombocytopenia
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction
* 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, natural or adopted child) 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 who have been disease free for ≥ 5 years.
18 Years
64 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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Hoover, Alabama, United States
Huntsville, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Sacramento, California, United States
San Diego, California, United States
Milford, Connecticut, United States
Coral Gables, Florida, United States
Melbourne, Florida, United States
Pinellas Park, Florida, United States
South Miami, Florida, United States
Boise, Idaho, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Binghamton, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Allentown, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Dakota Dunes, South Dakota, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Marshfield, Wisconsin, United States
Countries
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References
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Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.
Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16.
Related Links
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Related Info
Other Identifiers
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U1111-1124-8066
Identifier Type: OTHER
Identifier Source: secondary_id
QID01
Identifier Type: -
Identifier Source: org_study_id
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