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

Sanofi

Status and phase: Active, not recruiting; Phase 3

Conditions: Influenza

Treatments: Biological: High-Dose trivalent influenza vaccine (Split virion, Inactivated); Biological: Standard-dose trivalent influenza vaccine (Split virion, Inactivated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06641180

QHD00042

U1111-1305-7370 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

The study duration will be approximately 180 days (+ 14 days).

Enrollment: 1,178 patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,178 participants in 2 patient groups

IIV-HD

Experimental group

Description:

Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1

Treatment:

Biological: High-Dose trivalent influenza vaccine (Split virion, Inactivated)

IIV-SD

Active Comparator group

Description:

Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1

Treatment:

Biological: Standard-dose trivalent influenza vaccine (Split virion, Inactivated)