Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
NCT ID: NCT03282240
Last Updated: 2022-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2670 participants
INTERVENTIONAL
2017-09-08
2018-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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QIV-HD
Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.
QIV-HD
0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
TIV-HD1 (Licensed TIV-HD1)
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Licensed TIV-HD1
0.5 mL-dose was administered IM into the upper arm area.
TIV-HD2 (Investigational TIV-HD2)
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Investigational TIV-HD2
0.5 mL-dose was administered IM into the upper arm area.
Interventions
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QIV-HD
0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
Licensed TIV-HD1
0.5 mL-dose was administered IM into the upper arm area.
Investigational TIV-HD2
0.5 mL-dose was administered IM into the upper arm area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form had 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.
* Previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine.
* 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 vaccines 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.
* Alcohol or 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, 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 participants who have a history of neoplastic disease and have been disease free for \>= 5 years).
* 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 participant should not be included in the trial until the condition has resolved or the febrile event had 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, a Sanofi Company
Locations
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Sanofi Pasteur Investigational Site 037
Anaheim, California, United States
Sanofi Pasteur Investigational Site 029
Redding, California, United States
Sanofi Pasteur Investigational Site 003
San Diego, California, United States
Sanofi Pasteur Investigational Site 016
Colorado Springs, Colorado, United States
Sanofi Pasteur Investigational Site 035
Milford, Connecticut, United States
Sanofi Pasteur Investigational Site 031
Hollywood, Florida, United States
Sanofi Pasteur Investigational Site 009
Jacksonville, Florida, United States
Sanofi Pasteur Investigational Site 017
Jacksonville, Florida, United States
Sanofi Pasteur Investigational Site 030
Stockbridge, Georgia, United States
Sanofi Pasteur Investigational Site 010
Boise, Idaho, United States
Sanofi Pasteur Investigational Site 034
Meridian, Idaho, United States
Sanofi Pasteur Investigational Site 021
Council Bluffs, Iowa, United States
Sanofi Pasteur Investigational Site 023
Wichita, Kansas, United States
Sanofi Pasteur Investigational Site 028
Wichita, Kansas, United States
Sanofi Pasteur Investigational Site 012
Bardstown, Kentucky, United States
Sanofi Pasteur Investigational Site 018
Metairie, Louisiana, United States
Sanofi Pasteur Investigational Site 026
Biloxi, Mississippi, United States
Sanofi Pasteur Investigational Site 014
St Louis, Missouri, United States
Sanofi Pasteur Investigational Site 011
Omaha, Nebraska, United States
Sanofi Pasteur Investigational Site 024
Las Vegas, Nevada, United States
Sanofi Pasteur Investigational Site 008
Rochester, New York, United States
Sanofi Pasteur Investigational Site 005
Wilmington, North Carolina, United States
Sanofi Pasteur Investigational Site 036
Winston-Salem, North Carolina, United States
Sanofi Pasteur Investigational Site 004
Cleveland, Ohio, United States
Sanofi Pasteur Investigational Site 015
Oklahoma City, Oklahoma, United States
Sanofi Pasteur Investigational Site 013
Warwick, Rhode Island, United States
Sanofi Pasteur Investigational Site 033
Mt. Pleasant, South Carolina, United States
Sanofi Pasteur Investigational Site 001
Nashville, Tennessee, United States
Sanofi Pasteur Investigational Site 002
Dallas, Texas, United States
Sanofi Pasteur Investigational Site 025
Tomball, Texas, United States
Sanofi Pasteur Investigational Site 027
Salt Lake City, Utah, United States
Sanofi Pasteur Investigational Site 006
Salt Lake City, Utah, United States
Sanofi Pasteur Investigational Site 019
Salt Lake City, Utah, United States
Sanofi Pasteur Investigational Site 020
South Jordan, Utah, United States
Sanofi Pasteur Investigational Site 022
West Jordan, Utah, United States
Sanofi Pasteur Investigational Site 038
Norfolk, Virginia, United States
Countries
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References
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Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related info
Other Identifiers
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U1111-1183-5556
Identifier Type: OTHER
Identifier Source: secondary_id
QHD00013
Identifier Type: -
Identifier Source: org_study_id
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