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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06361875 | A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above | PHASE1 | COMPLETED | 910 | — | — | Apr 1, 2024 | Jun 9, 2025 | Jun 19, 2025 | 20 | United States, Honduras +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: Injection site pain, Injection site erythema, and Injection site swelling
Adverse reactions pre-listed in the protocol and case report form (CRF) Systemic reactions: fever, headache, fatigue, myalgia, arthralgia, chills
AEs that do not fulfill the conditions of solicited reactions
MAAEs reported up to 180 days after injection
SAEs reported throughout the study
AESIs reported throughout the study (approximately 12 months)
AESIs reported throughout the study
Out-of-range biological test results (including shift from baseline values)
Hemagglutinin inhibition (HAI) antibody (Ab) titers at D01 and D29
Individual HAI Ab titer ratio D29/D01
Number of participants with HAI Ab 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
HAI Ab titer ≥ 40 (1/dil) at D29
| Arm | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5421 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5424 |
| Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2 | EXPERIMENTAL | participants will receive a single dose of QIV mRNA vaccine MRT5424 |
| Quadrivalent Influenza SD Vaccine | ACTIVE_COMPARATOR | participants will receive a single dose of QIV-SD vaccine |
| Quadrivalent Influenza HD Vaccine | ACTIVE_COMPARATOR | participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only) |
| Quadrivalent Influenza RIV4 Vaccine | ACTIVE_COMPARATOR | participants will receive a single dose of RIV4 vaccine |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5421 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection |
| Quadrivalent Influenza mRNA Vaccine MRT5424 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection |
| Quadrivalent Influenza mRNA Vaccine MRT5429 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection |
| Quadrivalent Influenza Standard Dose Vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection |
| Quadrivalent Influenza High-Dose Vaccine | BIOLOGICAL | Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection |
| Quadrivalent Recombinant Influenza Vaccine | BIOLOGICAL | Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection |
Inclusion Criteria: - Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbea...