Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

NCT05624606
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
682
clinicaltrials.gov
Lead sponsor
Sanofi Pasteur, a Sanofi Company
clinicaltrials.gov
Start date
2022-11-28
clinicaltrials.gov
Number of sites
25
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
clinicaltrials.gov
Official title
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adults Aged 18 Years and Older
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2024-03-28
clinicaltrials.gov
First posted
2022-11-22
clinicaltrials.gov
Registry last updated
2025-03-18
clinicaltrials.gov
Primary completion date
2024-03-28
clinicaltrials.gov
Start date
2022-11-28
clinicaltrials.gov

Actual participants
682
clinicaltrials.gov
Participants
682
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
25
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Sanofi Pasteur, a Sanofi Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05624606
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05624606
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
This is a parallel-group prevention study with up to 6 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 reactions or systemic reactions

    Timeframe: Within 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: Within 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: Within 180 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 1 until Day 366

    SAEs reported throughout the study

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

    Timeframe: Within 8 days after injection

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

  7. Individual Hemagglutination inhibition (HAI) titer

    Timeframe: 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: Day 1 and Day 29

  9. Individual HAI titer ratio

    Timeframe: 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: 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: Day 29

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

    Timeframe: Day 1 and Day 29

  1. Neutralizing Ab titers

    Timeframe: Day 1 and Day 29

    Neutralizing Ab titers expressed as GMTs

  2. Individual neutralizing antibodies titer ratio

    Timeframe: Day 1 and Day 29

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

    Timeframe: 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: Day 91, Day 181 and Day 366

  6. Individual antibodies HAI 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 (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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Joint Clinical Trials Huntington Park Site Number : 8400032Huntington Park, United States
  • Long Beach Clinical Trials Site Number : 8400056Long Beach, United States
  • Velocity Clinical Research, North Hollywood Site Number : 8400063North Hollywood, United States
  • California Research Foundation Site Number : 8400001San Diego, United States
  • SIMEDHealth, LLC Site Number : 8400042Gainesville, United States
  • Indago Research and Health Center Site Number : 8400002Hialeah, United States
  • Research Centers of America Site Number : 8400011Hollywood, United States
  • Florida International Research Center Site Number : 8400009Miami, United States
  • Palm Beach Research Center Site Number : 8400041West Palm Beach, United States
  • Velocity Clinical Research Site Number : 8400024Meridian, United States
  • Brengle Family Medicine Site Number : 8400040Indianapolis, United States
  • AMR Lexington Site Number : 8400035Lexington, United States
  • Meridian Clinical Research Site Number : 8400017Norfolk, United States
  • Velocity Clinical Research Site Number : 8400034Omaha, United States
  • WR-CRCN, LLC Site Number : 8400060Las Vegas, United States
  • Coastal Carolina Research Center - N Charleston Site Number : 8400007North Charleston, United States
  • AMR Knoxville Site Number : 8400021Knoxville, United States
  • Elligo Health Research, Inc. Site Number : 8400037Austin, United States
  • Tekton Research, Inc Site Number : 8400051Austin, United States
  • DM Clinical Research Site Number : 8400046Humble, United States
  • Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043San Antonio, United States
  • DM Clinical Research - Sugar Land Site Number : 8400045Sugar Land, United States
  • Martin Diagnostic Clinic Site Number : 8400058Tomball, United States
  • Investigational Site Number : 6300002Barrio Sabana, Puerto Rico
  • Investigational Site Number : 6300001San Juan, Puerto Rico
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1275-1516
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (5)