Clinical trial NCT06641180: Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
Official title: A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate the Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With a Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 1178
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab)
timeFrame: Day 1 and Day 29
measure: Percentage of participants with seroconversion for influenza vaccine antibodies
timeFrame: Day 29
Secondary outcomes:
measure: Geometric Mean of Individual Titer Ratio (GMTR)
timeFrame: Day 1 and Day 29
measure: Percentage of participants with detectable HAI titer (HAI titer ≥ 10 [1/dil])
timeFrame: Day 1 and Day 29
measure: Percentage of participants with HAI titer ≥ 40 (1/dil)
timeFrame: Day 29
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Number of participants with solicited injection site reactions
timeFrame: Up to 7 days after vaccination
measure: Number of participants with solicited systemic reaction
timeFrame: Up to 7 days after vaccination
measure: Number of participants with unsolicited AEs
timeFrame: Up to 28 days after vaccination
measure: Number of participants with medically attended adverse events (MAAEs)
timeFrame: Throughout the study, approximately 180 days
measure: Number of participants with adverse events of special interest (AESIs)
timeFrame: Throughout the study, approximately 180 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Throughout the study, approximately 180 days
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: CenExel CNS- Site Number : 8400005
state: California
city: Fort Myers
country: United States
facility: Alliance for Multispeciality Research - Fort Myers- Site Number : 8400019
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America - Hollywood- Site Number : 8400010
state: Florida
city: Columbus
country: United States
facility: IACT Health - Columbus - Talbotton Road- Site Number : 8400011
state: Georgia
city: Decatur
country: United States
facility: Cenexel IRA - iResearch Atlanta- Site Number : 8400007
state: Georgia
city: Decatur
country: United States
facility: The Hope Clinic of Emory Vaccine Center- Site Number : 8400017
state: Georgia
city: Rincon
country: United States
facility: Centricity Research - Rincon- Site Number : 8400012
state: Georgia
city: Savannah
country: United States
facility: Cenexel IRS - iResearch Savannah- Site Number : 8400008
state: Georgia
city: Newton
country: United States
facility: Alliance for Multispeciality Research - Newton- Site Number : 8400003
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispeciality Research - Lexington- Site Number : 8400002
state: Kentucky
city: Gaithersburg
country: United States
facility: CBH Health - Gaithersburg- Site Number : 8400004
state: Maryland
city: Berlin
country: United States
facility: Hassman Research Institute - Berlin- Site Number : 8400006
state: New Jersey
city: Morehead City
country: United States
facility: Centricity Morehead- Site Number : 8400014
state: North Carolina
city: New Bern
country: United States
facility: Centricity New Bern- Site Number : 8400015
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research Columbus- Site Number : 8400016
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research- Site Number : 8400018
state: Oregon
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research - Volunteer Research Group- Site Number : 8400001
state: Tennessee
city: Salt Lake City
country: United States
facility: JBR Clinical Research- Site Number : 8400009
state: Utah
city: Suffolk
country: United States
facility: Centricity Research - Suffolk Primary Care - Centricity - PPDS- Site Number : 8400013
state: Virginia
city: Seattle
country: United States
facility: Kaiser Permanente Washington- Site Number : 8400024
state: Washington
Study officials:
References: