Clinical trial NCT05553301: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older
Official title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sentinel Cohort: Open label

Main Cohort:

* Open label (Sponsor, except laboratory testing personnel)
* Blinded (Sites, except for those preparing/administering study intervention)
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

Detailed description: Study duration is approximately 12 months.

Eligibility criteria: Inclusion Criteria:

* Aged 18 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 12 weeks after study intervention administration.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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)
* Previous history of myocarditis, pericarditis, and / or myopericarditis
* Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
* Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
* Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Within 30 minutes after injection
measure: Number of participants with solicited injection site and systemic reactions
timeFrame: Up to 7 days after injection
measure: Number of participants with unsolicited AEs
timeFrame: Up to 28 days after injection
measure: Number of participants with medically attended adverse events (MAAE)s
timeFrame: Up to 28 days after injection
measure: Number of participants with serious adverse events (SAEs)
timeFrame: From Day one to Day 366
measure: Number of participants with out-of-range biological test results
timeFrame: Up to 8 days after injection
measure: Individual Hemagglutination inhibition (HAI) titer
timeFrame: At Day 1 and Day 29
measure: Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
timeFrame: At Day 1 and Day 29
measure: Individual HAI titer ratio
timeFrame: At Day 1 and Day 29
measure: Number of participants archiving HAI seroconversion against Antigens
timeFrame: At Day 1 and Day 29
measure: Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
timeFrame: At Day 29
measure: Percentage of participants with 2-fold and 4-fold rise in HAI titers
timeFrame: At Day 1 and Day 29
Secondary outcomes:
measure: Neutralizing Ab titers
timeFrame: At Day 1 and Day 29
measure: Individual neutralizing antibodies titer ratio
timeFrame: At Day 1 and Day 29
measure: Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
timeFrame: At Day 1 and Day 29
measure: Individual HAI Ab titer ratio
timeFrame: Day 1, Day 91, Day 181 and Day 366
measure: Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
timeFrame: At Day 91, Day 181 and Day 366
measure: Individual neutralizing Ab titer ratio
timeFrame: Day 1, Day 91, Day 181 and Day 366
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Site Number : 8400025
state: California
city: San Diego
country: United States
facility: Optimal Research Site Number : 8400059
state: California
city: San Diego
country: United States
facility: California Research Foundation Site Number : 8400008
state: California
city: DeLand
country: United States
facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400052
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC Site Number : 8400024
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Site Number : 8400014
state: Florida
city: Hollywood
country: United States
facility: Cenexel Research Centers of America Site Number : 8400048
state: Florida
city: Miami
country: United States
facility: Dade Research Center Site Number : 8400011
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC Site Number : 8400038
state: Florida
city: Miami
country: United States
facility: Florida International Research Center Site Number : 8400051
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center Site Number : 8400020
state: Florida
city: Melrose Park
country: United States
facility: DM Clinical Research Site Number : 8400032
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research - Chicago Site Number : 8400028
state: Illinois
city: Indianapolis
country: United States
facility: Brengle Family Medicine Site Number : 8400005
state: Indiana
city: Lexington
country: United States
facility: AMR Lexington Site Number : 8400054
state: Kentucky
city: Kansas City
country: United States
facility: AMR Kansas City Site Number : 8400006
state: Missouri
city: Omaha
country: United States
facility: Velocity Clinical Research Site Number : 8400003
state: Nebraska
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston Site Number : 8400010
state: South Carolina
city: Knoxville
country: United States
facility: AMR Knoxville Site Number : 8400046
state: Tennessee
city: Austin
country: United States
facility: Elligo Health Research Site Number : 8400056
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute Site Number : 8400030
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. Site Number : 8400026
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugar Land Site Number : 8400031
state: Texas
city: Barrio Sabana
country: Puerto Rico
facility: Investigational Site Number : 6300003
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: