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OpenTrials
Completed

NCT Number: NCT05553301

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

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.

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Key information

Conditions

Influenza Immunization Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number : 6300003, Barrio Sabana, Puerto Rico

Loading trial locations.

About this study

Study duration is approximately 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quadrivalent Influenza mRNA Vaccine MRT5407

Biological

Pharmaceutical Form: Liquid frozen solution in a vial

Route of Administration: Intramuscular Injection

Quadrivalent Recombinant Influenza Vaccine

Biological

Pharmaceutical Form: Liquid frozen solution in a vial

Route of Administration: Intramuscular Injection

Other names: Flublok Quadrivalent®

Quadrivalent Influenza Standard Dose Vaccine

Biological

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

Route of Administration: Intramuscular Injection

Other names: Fluzone Qudrivalent®

Quadrivalent Influenza High-Dose Vaccine

Biological

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

Route of Administration: Intramuscular Injection

Other names: Fluzone High-Dose Quadrivalent®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2022
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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