Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
NCT ID: NCT06641180
Last Updated: 2025-12-03
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
PHASE3
1180 participants
INTERVENTIONAL
2024-11-04
2025-06-24
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
QUADRUPLE
* Participants, Sponsor study staff\*, investigators, and study site staff will not know which study vaccine is administered during the study conduct
* Dedicated study site staff who prepare/administer the study interventions and are not involved in the safety evaluation will know which study vaccine is administered.
* Select sponsor staff will be unblinded after the code break for primary completion analysis.
Study Groups
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IIV-HD
Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1
High-Dose trivalent influenza vaccine (Split virion, Inactivated)
Liquid suspension for intramuscular injection
IIV-SD
Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1
Standard-dose trivalent influenza vaccine (Split virion, Inactivated)
Liquid suspension for intramuscular injection
Interventions
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High-Dose trivalent influenza vaccine (Split virion, Inactivated)
Liquid suspension for intramuscular injection
Standard-dose trivalent influenza vaccine (Split virion, Inactivated)
Liquid suspension for intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
OR
* Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
* A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at enrollment before the first dose of study intervention.
* Informed consent form has been signed and dated.
* Able to attend all scheduled visits and to comply with all study procedures.
Exclusion Criteria
* Personal or family history of Guillain-Barré Syndrome (GBS).
* Known systemic hypersensitivity to any of the study intervention components (Section 1.1, Section 6.1), or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances.
* Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment.
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine prior to the second blood drawing (ie. approximately 4 weeks after the study intervention administration).
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine.
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie.
parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
50 Years
64 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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CenExel CNS- Site Number : 8400005
Los Alamitos, California, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400019
Fort Myers, Florida, United States
Research Centers of America - Hollywood- Site Number : 8400010
Hollywood, Florida, United States
IACT Health - Columbus - Talbotton Road- Site Number : 8400011
Columbus, Georgia, United States
Cenexel IRA - iResearch Atlanta- Site Number : 8400007
Decatur, Georgia, United States
The Hope Clinic of Emory Vaccine Center- Site Number : 8400017
Decatur, Georgia, United States
Centricity Research - Rincon- Site Number : 8400012
Rincon, Georgia, United States
Cenexel IRS - iResearch Savannah- Site Number : 8400008
Savannah, Georgia, United States
Alliance for Multispeciality Research - Newton- Site Number : 8400003
Newton, Kansas, United States
Alliance for Multispeciality Research - Lexington- Site Number : 8400002
Lexington, Kentucky, United States
CBH Health - Gaithersburg- Site Number : 8400004
Gaithersburg, Maryland, United States
Hassman Research Institute - Berlin- Site Number : 8400006
Berlin, New Jersey, United States
Centricity Morehead- Site Number : 8400014
Morehead City, North Carolina, United States
Centricity New Bern- Site Number : 8400015
New Bern, North Carolina, United States
Aventiv Research Columbus- Site Number : 8400016
Columbus, Ohio, United States
Kaiser Permanente Center for Health Research- Site Number : 8400018
Portland, Oregon, United States
Alliance for Multispecialty Research - Volunteer Research Group- Site Number : 8400001
Knoxville, Tennessee, United States
JBR Clinical Research- Site Number : 8400009
Salt Lake City, Utah, United States
Centricity Research - Suffolk Primary Care - Centricity - PPDS- Site Number : 8400013
Suffolk, Virginia, United States
Kaiser Permanente Washington- Site Number : 8400024
Seattle, Washington, United States
Countries
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Related Links
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QHD00042 Plain Language Results Summary
Other Identifiers
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U1111-1305-7370
Identifier Type: REGISTRY
Identifier Source: secondary_id
QHD00042
Identifier Type: -
Identifier Source: org_study_id
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