Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Influenza mRNA Vaccine MRT5407 · 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 MRT5407 dose level 1 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine (dose level 1) |
| Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine (dose level 2) |
| Group 3: RIV4 | ACTIVE_COMPARATOR | participants will receive a single dose of RIV4 vaccine |
| Group 4: QIV-SD | ACTIVE_COMPARATOR | participants will receive a single dose of QIV-SD vaccine |
| Group 5: QIV-HD | ACTIVE_COMPARATOR | participants will receive a single dose of QIV -HD vaccine (for elderly only) |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5407 | 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 * 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 ...
Quadrivalent Influenza mRNA Vaccine MRT5407 is an investigational vaccine being developed for influenza immunization. It is designed to provide protection against influenza by targeting four different influenza virus strains. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
Quadrivalent Influenza mRNA Vaccine MRT5407 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 MRT5407 is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still undergoing clinical evaluation.
Quadrivalent Influenza mRNA Vaccine MRT5407 has one completed clinical trial, identified as NCT05553301. This Phase 1 study evaluated the safety and immunogenicity of the vaccine in adult participants aged 18 years and older. The trial enrolled 560 participants and was conducted in the United States and Puerto Rico.
Yes, Quadrivalent Influenza mRNA Vaccine MRT5407 is also known as MRT5407. The vaccine is being developed by Sanofi for influenza immunization. In clinical trial records, it is referred to by the name MRT5407, which is the same investigational vaccine.