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 vaccine being developed for influenza immunization in adults 18 years of age and older. It is designed to provide protection against influenza, a contagious respiratory illness. The vaccine is currently in clinical development and is not yet approved for public use.
Quadrivalent Influenza mRNA Vaccine MRT5413 is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine.
Quadrivalent Influenza mRNA Vaccine MRT5413 is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still undergoing clinical evaluation to assess its safety and immune response.
Quadrivalent Influenza mRNA Vaccine MRT5413 has been studied in one clinical trial, identified as NCT05650554. This Phase 1 trial, titled 'Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants 18 Years of Age and Older,' was completed and enrolled 682 participants across the United States, Australia, and Puerto Rico.
Yes, Quadrivalent Influenza mRNA Vaccine MRT5413 is also known as MRT5413. The shorter name MRT5413 is used in clinical trial registries and scientific literature. Both names refer to the same investigational vaccine being developed by Sanofi for influenza immunization.