Clinical trial NCT05624606: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
Official title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 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: 2022-11-22
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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older.

Detailed description: 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:

* 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 IM vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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 reactions or systemic reactions
timeFrame: Within 7 days after injection
measure: Number of participants with unsolicited AEs
timeFrame: Within 28 days after injection
measure: Number of participants with medically attended adverse events (MAAE)s
timeFrame: Within 180 days after injection
measure: Number of participants with serious adverse events (SAEs)
timeFrame: From Day 1 until Day 366
measure: Number of participants with out-of-range biological test results
timeFrame: Within 8 days after injection
measure: Individual Hemagglutination inhibition (HAI) titer
timeFrame: Day 1 and Day 29
measure: Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
timeFrame: Day 1 and Day 29
measure: Individual HAI titer ratio
timeFrame: Day 1 and Day 29
measure: Number of participants archiving HAI seroconversion against Antigens
timeFrame: Day 1 and Day 29
measure: Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
timeFrame: Day 29
measure: Percentage of participants with 2-fold and 4-fold rise in HAI titers
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: Neutralizing Ab titers
timeFrame: Day 1 and Day 29
measure: Individual neutralizing antibodies titer ratio
timeFrame: Day 1 and Day 29
measure: Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
timeFrame: 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: 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: Huntington Park
country: United States
facility: Joint Clinical Trials Huntington Park Site Number : 8400032
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Site Number : 8400056
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood Site Number : 8400063
state: California
city: San Diego
country: United States
facility: California Research Foundation Site Number : 8400001
state: California
city: Gainesville
country: United States
facility: SIMEDHealth, LLC Site Number : 8400042
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Site Number : 8400002
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America Site Number : 8400011
state: Florida
city: Miami
country: United States
facility: Florida International Research Center Site Number : 8400009
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center Site Number : 8400041
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research Site Number : 8400024
state: Idaho
city: Indianapolis
country: United States
facility: Brengle Family Medicine Site Number : 8400040
state: Indiana
city: Lexington
country: United States
facility: AMR Lexington Site Number : 8400035
state: Kentucky
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 : 8400034
state: Nebraska
city: Las Vegas
country: United States
facility: WR-CRCN, LLC Site Number : 8400060
state: Nevada
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - N Charleston Site Number : 8400007
state: South Carolina
city: Knoxville
country: United States
facility: AMR Knoxville Site Number : 8400021
state: Tennessee
city: Austin
country: United States
facility: Elligo Health Research, Inc. Site Number : 8400037
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc Site Number : 8400051
state: Texas
city: Humble
country: United States
facility: DM Clinical Research Site Number : 8400046
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugar Land Site Number : 8400045
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic Site Number : 8400058
state: Texas
city: Barrio Sabana
country: Puerto Rico
facility: Investigational Site Number : 6300002
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: