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

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza Immunization

Treatments: Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD; Biological: Quadrivalent Influenza mRNA Vaccine MRT5410; Biological: Quadrivalent Recombinant Influenza vaccine RIV4; Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624606

U1111-1275-1516 (Registry Identifier)

VAV00020

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 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.

Full description

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

• 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.

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 MRT5410 low dose

Experimental group

Description:

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

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose

Experimental group

Description:

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

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

Experimental group

Description:

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

Treatment:

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 4: RIV4

Active Comparator group

Description:

participants will receive a single dose of RIV4 vaccine

Treatment:

Biological: Quadrivalent Recombinant Influenza vaccine RIV4

Group 5: QIV-SD

Active Comparator group

Description:

participants will receive a single dose of QIV-SD vaccine

Treatment:

Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD

Group 6: QIV-HD

Active Comparator group

Description:

participants will receive a single dose of QIV -HD vaccine

Treatment:

Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD