Clinical trial NCT05650554: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
Official title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 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: 2022-12-14
Enrollment: 682
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 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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 (US) and aged 21 years on the day of inclusion (Puerto Rico)
* 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

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 or 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 180 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 antibodies HAI titer ratio
timeFrame: Day 1, Day 91, Day 181 and Day 366
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Velocity Clinical Research-Chula Vista Site Number : 8400061
state: California
city: Gardena
country: United States
facility: Velocity Gardena Site Number : 8400062
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Site Number : 8400052
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood Site Number : 8400051
state: California
city: San Diego
country: United States
facility: California Research Foundation Site Number : 8400006
state: California
city: DeLand
country: United States
facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032
state: Florida
city: Edgewater
country: United States
facility: Velocity New Smyrna Beach Site Number : 8400063
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC Site Number : 8400014
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Site Number : 8400044
state: Florida
city: Hollywood
country: United States
facility: Cenexel Research Centers of America Site Number : 8400011
state: Florida
city: Miami
country: United States
facility: Florida International Research Center Site Number : 8400045
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC Site Number : 8400060
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Center Site Number : 8400036
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research Site Number : 8400022
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research Site Number : 8400024
state: Idaho
city: River Forest
country: United States
facility: DM Clinical Research - Chicago Site Number : 8400025
state: Illinois
city: Indianapolis
country: United States
facility: Brengle Family Medicine Site Number : 8400039
state: Indiana
city: Lincoln
country: United States
facility: Velocity Clinical Research Lincoln Site Number : 8400049
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research Site Number : 8400017
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research Site Number : 8400008
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research. Inc. Site Number : 8400027
state: New York
city: Cleveland
country: United States
facility: Velocity Clinical Research Site Number : 8400001
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence Site Number : 8400019
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research Center Site Number : 8400042
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch Site Number : 8400013
state: Tennessee
city: Austin
country: United States
facility: Elligo Health Research, Inc. Site Number : 8400002
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- Bellaire Site Number : 8400026
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400016
state: Texas
city: Darlinghurst
country: Australia
facility: Investigational Site Number : 0360004
state: New South Wales
city: Kanwal
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: Maroubra
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Morayfield
country: Australia
facility: Investigational Site Number : 0360001
state: Queensland
city: North Melbourne
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Barrio Sabana
country: Puerto Rico
facility: Investigational Site Number : 6300001
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: