Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Influenza mRNA Vaccine MRT5410 · 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 MRT5410 low dose | EXPERIMENTAL | participants will receive a single dose (low) of QIV mRNA vaccine |
| Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose | EXPERIMENTAL | participants will receive a single dose (medium) of QIV mRNA vaccine |
| Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose | EXPERIMENTAL | participants will receive a single dose (high) of QIV mRNA vaccine |
| 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 |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5410 | BIOLOGICAL | Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular |
| Quadrivalent Recombinant Influenza vaccine RIV4 | BIOLOGICAL | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
| Quadrivalent Inactivated Influenza Standard Dose QIV-SD | BIOLOGICAL | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
| Quadrivalent Inactivated Influenza High Dose QIV-HD | BIOLOGICAL | Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular |
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 co...
Quadrivalent Influenza mRNA Vaccine MRT5410 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 healthy adult participants aged 18 years and older.
Quadrivalent Influenza mRNA Vaccine MRT5410 is being developed for influenza immunization, meaning prevention of influenza infection. It targets four influenza strains in a single vaccine. The candidate is investigational and has been evaluated in a Phase 1 trial in healthy adults, not yet in later-stage or pivotal studies.
Sanofi is developing Quadrivalent Influenza mRNA Vaccine MRT5410. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the vaccine's clinical program, which includes a completed Phase 1 trial conducted in the United States and Puerto Rico.
Quadrivalent Influenza mRNA Vaccine MRT5410 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The candidate is investigational and has not been approved by the FDA for influenza immunization.
Quadrivalent Influenza mRNA Vaccine MRT5410 has been studied in one Phase 1 trial, NCT05624606, titled Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older. The trial enrolled 682 participants, was randomized, double-blind, and active-controlled, and has completed.