Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza Immunization

Treatments: Biological: Quadrivalent Influenza Standard Dose Vaccine; Biological: Quadrivalent Influenza High-Dose Vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine; Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Study type: Interventional

Funder types: Industry

Identifiers

NCT05650554

U1111-1279-3180 (Registry Identifier)

VAV00029

Details and patient eligibility

About

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 messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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.

Full description

Study duration is approximately 12 months.

Enrollment: 682 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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682 participants in 6 patient groups

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose

Experimental group

Description:

participants will receive a single dose of QIV mRNA vaccine (low dose)

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose

Experimental group

Description:

participants will receive a single dose of QIV mRNA vaccine (medium dose)

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose

Experimental group

Description:

participants will receive a single dose of QIV mRNA vaccine (high dose)

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 4: RIV4

Active Comparator group

Description:

participants will receive a single dose of RIV4 vaccine

Treatment:

Biological: Quadrivalent Recombinant Influenza Vaccine

Group 5: QIV-SD

Active Comparator group

Description:

participants will receive a single dose of QIV-SD vaccine

Treatment:

Biological: Quadrivalent Influenza Standard Dose Vaccine

Group 6: QIV-HD

Active Comparator group

Description:

participants will receive a single dose of QIV -HD vaccine (for elderly only)

Treatment:

Biological: Quadrivalent Influenza High-Dose Vaccine