Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Influenza mRNA Vaccine MRT5413 · 1 trial · 1 indication
Unsolicited systemic AEs that occur within 30 minutes after vaccination
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
AEs that do not fulfill the conditions of solicited reactions
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
SAEs reported throughout the study
Out-of-range biological test results (including shift from baseline values)
Antibody titers are expressed as GMTs at baseline and post-baseline
Ratios of antibody titers measured by HAI in each group before and after vaccination
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
| Arm | Type | Description |
|---|---|---|
| Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine (low dose) |
| Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine (medium dose) |
| Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine (high dose) |
| Group 4: RIV4 | ACTIVE_COMPARATOR | participants will receive a single dose of RIV4 vaccine |
| Group 5: QIV-SD | ACTIVE_COMPARATOR | participants will receive a single dose of QIV-SD vaccine |
| Group 6: QIV-HD | ACTIVE_COMPARATOR | participants will receive a single dose of QIV -HD vaccine (for elderly only) |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5413 | 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 |
| Quadrivalent Influenza Standard Dose Vaccine | BIOLOGICAL | Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection |
| Quadrivalent Influenza High-Dose Vaccine | BIOLOGICAL | Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection |
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 b...
Quadrivalent Influenza mRNA Vaccine MRT5413 is an investigational mRNA-based vaccine developed by Sanofi for influenza immunization. It is designed to protect against four influenza virus strains, which is what quadrivalent means. The vaccine is in Phase 1 clinical development and has been studied in one completed trial.
Quadrivalent Influenza mRNA Vaccine MRT5413 is being developed for influenza immunization in adults 18 years of age and older. Its intended use is to prevent influenza infection by stimulating an immune response against four influenza strains. It is investigational and has not been approved for use.
Quadrivalent Influenza mRNA Vaccine MRT5413 is made by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the developer of the vaccine and conducted the clinical trial evaluating it.
Quadrivalent Influenza mRNA Vaccine MRT5413 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The vaccine remains investigational and has not been approved by the FDA.
Quadrivalent Influenza mRNA Vaccine MRT5413 has been evaluated in one completed Phase 1 trial, NCT05650554, titled Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants 18 Years of Age and Older. The trial enrolled 682 participants across the United States, Australia, and Puerto Rico.
The Phase 1 trial NCT05650554 was a randomized, double-blind, active-controlled study of Quadrivalent Influenza mRNA Vaccine MRT5413 in healthy adult volunteers aged 18 years and older. It enrolled 682 participants across the United States, Australia, and Puerto Rico and has been completed.