Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age

Completed · Phase 3

Conditions studied: Influenza

In brief

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.

Key facts

Study ID

NCT06641180

Run by

Sanofi Pasteur, a Sanofi Company

People needed

1180

Starts

2024-11-04

Expected to finish

2025-06-24

Last updated by the study team

2025-12-03

Who can join

Age: 50 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 50 to 64 years on the day of inclusion.
• 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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