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Completed

NCT Number: NCT06361875

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) 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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number : 3400001, San Pedro Sula, Honduras

Loading trial locations.

About this study

Study duration per participant is approximately 12 months.

  • Treatment duration: 1 injection of one of the 7 QIV mRNA or one of the controls
  • Dose escalation with sequential enrollment

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries.

  • 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.
  • A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the 1st dose of study intervention 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)
  • Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
  • Previous history of myocarditis, pericarditis, and / or myopericarditis
  • Known history of previous episodes of Gillian-Barre Syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
  • Participants with an ECG that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • 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
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
  • 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
  • Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the 1st visit (V01)
  • Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
  • 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 MRT5421

Biological

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection

Quadrivalent Influenza mRNA Vaccine MRT5424

Biological

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection

Quadrivalent Influenza mRNA Vaccine MRT5429

Biological

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection

Quadrivalent Influenza Standard Dose Vaccine

Biological

Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection

Other names: Fluzone Qudrivalent®

Quadrivalent Influenza High-Dose Vaccine

Biological

Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection

Other names: Fluzone High-Dose Quadrivalent®

Quadrivalent Recombinant Influenza Vaccine

Biological

Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection

Other names: Flublok Quadrivalent®

Primary outcomes

  1. Number of participants with immediate unsolicited systemic 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 reactions

    Time frame: Up to 7 days after injection

    Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: Injection site pain, Injection site erythema, and Injection site swelling

  3. Number of participants with solicited systemic reactions

    Time frame: Up to 7 days after injection

    Adverse reactions pre-listed in the protocol and case report form (CRF) Systemic reactions: fever, headache, fatigue, myalgia, arthralgia, chills

  4. Number of participants with unsolicited AEs

    Time frame: Up to 28 days after injection

    AEs that do not fulfill the conditions of solicited reactions

  5. Number of participants with medically attended adverse events (MAAEs)

    Time frame: Up to 180 days after injection

    MAAEs reported up to 180 days after injection

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

    Time frame: Throughout the study (approximately 12 months)

    SAEs reported throughout the study

  7. AESIs reported throughout the study

    Time frame: AESIs reported throughout the study (approximatley 12 months)

    AESIs reported throughout the study (approximately 12 months)

  8. Number of participants with adverse events of special interests (AESIs)

    Time frame: Throughout the study (approximately 12 months)

    AESIs reported throughout the study

  9. 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)

  10. Geometric Mean Titer (GMT)

    Time frame: At Day 1 and Day 29

    Hemagglutinin inhibition (HAI) antibody (Ab) titers at D01 and D29

  11. Geometric Mean of individual Titer Ratio (GMTR)

    Time frame: At Day 1 and Day 29

    Individual HAI Ab titer ratio D29/D01

  12. Seroconversion

    Time frame: At Day 1 and Day 29

    Number of participants with HAI Ab 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

  13. HAI Ab titer ≥ 40 (1/dil)

    Time frame: Day 29

    HAI Ab titer ≥ 40 (1/dil) at D29

Secondary outcomes

  1. Neutralizing Ab titers at D01 and D29

    Time frame: At Day 1 and Day 29

    Neutralizing Ab titers at D01 and D29

  2. Individual neutralizing antibodies titer ratio

    Time frame: At Day 1 and Day 29

    Individual neutralizing antibodies titer ratio D29/D01

  3. 2-fold and 4-fold increase in neutralizing titers

    Time frame: Day 1 through Day 29

    2-fold and 4-fold increase in neutralizing titers

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Phase I/II Study to Investigate the Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccines MRT5421, MRT5424, and MRT5429 in Healthy Participants Aged 18 Years and Above

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Jun 19, 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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