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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553301
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Influenza Immunization Biological: Quadrivalent Influenza mRNA Vaccine MRT5407 Biological: Quadrivalent Recombinant Influenza Vaccine Biological: Quadrivalent Influenza Standard Dose Vaccine Biological: Quadrivalent Influenza High-Dose Vaccine Phase 1 Phase 2

Detailed Description:
Study duration is approximately 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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).
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older
Actual Study Start Date : October 3, 2022
Estimated Primary Completion Date : January 19, 2024
Estimated Study Completion Date : January 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1
participants will receive a single dose of QIV mRNA vaccine (dose level 1)
Biological: Quadrivalent Influenza mRNA Vaccine MRT5407

Pharmaceutical Form: Liquid frozen solution in a vial

Route of Administration: Intramuscular Injection


Experimental: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2
participants will receive a single dose of QIV mRNA vaccine (dose level 2)
Biological: Quadrivalent Influenza mRNA Vaccine MRT5407

Pharmaceutical Form: Liquid frozen solution in a vial

Route of Administration: Intramuscular Injection


Active Comparator: Group 3: RIV4
participants will receive a single dose of RIV4 vaccine
Biological: Quadrivalent Recombinant Influenza Vaccine

Pharmaceutical Form: Liquid frozen solution in a vial

Route of Administration: Intramuscular Injection

Other Name: Flublok Quadrivalent®

Active Comparator: Group 4: QIV-SD
participants will receive a single dose of QIV-SD vaccine
Biological: Quadrivalent Influenza Standard Dose Vaccine

Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe

Route of Administration: Intramuscular Injection

Other Name: Fluzone Qudrivalent®

Active Comparator: Group 5: QIV-HD
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Biological: Quadrivalent Influenza High-Dose Vaccine

Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe

Route of Administration: Intramuscular Injection

Other Name: Fluzone High-Dose Quadrivalent®




Primary Outcome Measures :
  1. Number of participants with immediate adverse events (AEs) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: From Day one to Day 366 ]
    SAEs reported throughout the study

  6. Number of participants with out-of-range biological test results [ Time Frame: Up to 8 days after injection ]
    Out-of-range biological test results (including shift from baseline values)

  7. Individual Hemagglutination inhibition (HAI) titer [ Time Frame: 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] [ Time Frame: At Day 1 and Day 29 ]
  9. Individual HAI titer ratio [ Time Frame: 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 [ Time Frame: 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] [ Time Frame: At Day 29 ]
  12. Percentage of participants with 2-fold and 4-fold rise in HAI titers [ Time Frame: At Day 1 and Day 29 ]

Secondary Outcome Measures :
  1. Neutralizing Ab titers [ Time Frame: At Day 1 and Day 29 ]
    Neutralizing Ab titers expressed as GMTs

  2. Individual neutralizing antibodies titer ratio [ Time Frame: At Day 1 and Day 29 ]
  3. Percentage of participants with 2-fold and 4-fold increase in neutralizing titers [ Time Frame: At Day 1 and Day 29 ]
  4. Individual HAI Ab titer ratio [ Time Frame: 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] [ Time Frame: At Day 91, Day 181 and Day 366 ]
  6. Individual neutralizing Ab titer ratio [ Time Frame: Day 1, Day 91, Day 181 and Day 366 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553301


Contacts
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Contact: email recommended (Toll free for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT05553301    
Other Study ID Numbers: VAV00002
U1111-1271-1302 ( Registry Identifier: ICTRP )
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 29, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs