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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05624606 | Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older | PHASE1 | COMPLETED | 682 | — | — | Nov 28, 2022 | Mar 28, 2024 | Mar 18, 2025 | 25 | United States, Puerto Rico |
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...