Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05650554 | Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older | PHASE1 | COMPLETED | 682 | — | — | Dec 12, 2022 | Apr 2, 2024 | Mar 19, 2025 | 35 | United States, Australia +1 |
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...