Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

NCT05553301
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
560
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2022-10-03
clinicaltrials.gov
Number of sites
25
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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.
clinicaltrials.gov
Short title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older
clinicaltrials.gov
Official title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older
clinicaltrials.gov

Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2024-01-19
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First posted
2022-09-23
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Registry last updated
2025-01-24
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Primary completion date
2024-01-19
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Start date
2022-10-03
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Actual participants
560
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Participants
560
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
25
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05553301
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ClinicalTrials.gov ID
NCT05553301
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
This is a parallel-group prevention study with up to 5 arms that will be blinded to participants, investigators / sub-investigators, outcomes assessors, and laboratory personnel (with the exception of the sentinel safety portion of the study, which will be open-label). The Sponsor study staff will be unblinded (except laboratory testing personnel).
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of participants with immediate adverse events (AEs)

    Timeframe: Within 30 minutes after injection

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

  2. Number of participants with solicited injection site and systemic reactions

    Timeframe: Up to 7 days after injection

    Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills

  3. Number of participants with unsolicited AEs

    Timeframe: Up to 28 days after injection

    AEs that do not fulfill the conditions of solicited reactions

  4. Number of participants with medically attended adverse events (MAAE)s

    Timeframe: Up to 28 days after injection

    AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department

  5. Number of participants with serious adverse events (SAEs)

    Timeframe: From Day one to Day 366

    SAEs reported throughout the study

  6. Number of participants with out-of-range biological test results

    Timeframe: Up to 8 days after injection

    Out-of-range biological test results (including shift from baseline values)

  7. Individual Hemagglutination inhibition (HAI) titer

    Timeframe: At Day 1 and Day 29

    Antibody titers are expressed as GMTs at baseline and post-baseline

  8. Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]

    Timeframe: At Day 1 and Day 29

  9. Individual HAI titer ratio

    Timeframe: At Day 1 and Day 29

    Ratios of antibody titers measured by HAI in each group before and after vaccination

  10. Number of participants archiving HAI seroconversion against Antigens

    Timeframe: At Day 1 and Day 29

    Number of participants with titer \< 10 \[1/dil\] at Day 1 and post-vaccination titer ≥ 40 \[1/dil\] at Day 29, or titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold-rise in titer \[1/dil\] at Day 29

  11. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

    Timeframe: At Day 29

  12. Percentage of participants with 2-fold and 4-fold rise in HAI titers

    Timeframe: At Day 1 and Day 29

  1. Neutralizing Ab titers

    Timeframe: At Day 1 and Day 29

    Neutralizing Ab titers expressed as GMTs

  2. Individual neutralizing antibodies titer ratio

    Timeframe: At Day 1 and Day 29

  3. Percentage of participants with 2-fold and 4-fold increase in neutralizing titers

    Timeframe: At Day 1 and Day 29

  4. Individual HAI Ab titer ratio

    Timeframe: Day 1, Day 91, Day 181 and Day 366

  5. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

    Timeframe: At Day 91, Day 181 and Day 366

  6. Individual neutralizing Ab titer ratio

    Timeframe: Day 1, Day 91, Day 181 and Day 366

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • 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.

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.

Sources for eligibility
clinicaltrials.gov

  • Peninsula Research Associates Site Number : 8400025Rolling Hills Estates, United States
  • Optimal Research Site Number : 8400059San Diego, United States
  • California Research Foundation Site Number : 8400008San Diego, United States
  • Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400052DeLand, United States
  • SIMEDHealth, LLC Site Number : 8400024Gainesville, United States
  • Indago Research and Health Center Site Number : 8400014Hialeah, United States
  • Cenexel Research Centers of America Site Number : 8400048Hollywood, United States
  • Dade Research Center Site Number : 8400011Miami, United States
  • Suncoast Research Group, LLC Site Number : 8400038Miami, United States
  • Florida International Research Center Site Number : 8400051Miami, United States
  • Palm Beach Research Center Site Number : 8400020West Palm Beach, United States
  • DM Clinical Research Site Number : 8400032Melrose Park, United States
  • DM Clinical Research - Chicago Site Number : 8400028River Forest, United States
  • Brengle Family Medicine Site Number : 8400005Indianapolis, United States
  • AMR Lexington Site Number : 8400054Lexington, United States
  • AMR Kansas City Site Number : 8400006Kansas City, United States
  • Velocity Clinical Research Site Number : 8400003Omaha, United States
  • Coastal Carolina Research Center - N Charleston Site Number : 8400010North Charleston, United States
  • AMR Knoxville Site Number : 8400046Knoxville, United States
  • Elligo Health Research Site Number : 8400056Austin, United States
  • Sun Research Institute Site Number : 8400030San Antonio, United States
  • Clinical Trials of Texas, Inc. Site Number : 8400026San Antonio, United States
  • DM Clinical Research - Sugar Land Site Number : 8400031Sugar Land, United States
  • Investigational Site Number : 6300003Barrio Sabana, Puerto Rico
  • Investigational Site Number : 6300002San Juan, Puerto Rico
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1271-1302
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (5)