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 vaccine for influenza immunization in adults 18 years of age and older. It is designed to provide protection against influenza, though it is still in clinical development and not yet approved.
Quadrivalent Influenza mRNA Vaccine MRT5410 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Quadrivalent Influenza mRNA Vaccine MRT5410 is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still being studied for safety and immune response in clinical trials.
Quadrivalent Influenza mRNA Vaccine MRT5410 has been studied in one completed Phase 1 clinical trial, identified as NCT05624606. This trial assessed the safety and immunogenicity of the vaccine in 682 adult participants aged 18 years and older in the United States and Puerto Rico.
Yes, Quadrivalent Influenza mRNA Vaccine MRT5410 is the same as MRT5410. The full name includes the quadrivalent formulation, while MRT5410 is the shorter identifier used in clinical trial registries and scientific literature.