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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06744205 | A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older | PHASE1 | ACTIVE NOT_RECRUITING | 1,162 | — | — | Jan 6, 2025 | Apr 16, 2026 | May 30, 2025 | 24 | United States, Australia |
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Solicited injection site reactions pre-listed in the participant diary and in the case report form CRF
Solicited systemic reactions pre-listed in the participant diary and in the CRF
AEs that do not fulfill the conditions of solicited reactions
MAAEs reported up to 180 days after injection
Throughout the study
Throughout the study
Out-of-range biological test results (including shift from baseline values)
HAI 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-injection titer ≥ 40 \[1/dil\] at Day 29, or titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29
HAI Ab titer ≥ 40 (1/dil) at D29
NAI titers at D01 and D29
Number of participants with NAI Ab titer \< 10 \[1/dil\] at D01 and post-injection titer ≥ 40 \[1/dil\] at D29, or titer ≥ 10 \[1/dil\] at D01 and a ≥ 4-fold increase in titer \[1/dil\] at D29)
NAI Ab titer ≥ 40 (1/dil) at D29
2-fold and 4-fold rise in NAI titers from D01 to D29
| Arm | Type | Description |
|---|---|---|
| Group 1 - Hexavalent (Combination 1) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1) |
| Group 2 - Hexavalent (Combination 2) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2) |
| Group 3 - Hexavalent (Combination 3) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3) |
| Group 4 - Hexavalent (Combination 4) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4) |
| Group 5 - Hexavalent (Combination 5) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5) |
| Group 6 - Hexavalent (Combination 6) | EXPERIMENTAL | Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6) |
| Group 7 - TIV mRNA-HA Vaccine 1 | EXPERIMENTAL | Participants will receive a single dose of TIV mRNA-HA Vaccine 1 |
| Group 8 - TIV mRNA-NA | EXPERIMENTAL | Participants will receive a single dose of TIV mRNA-NA |
| Group 9 - TIV mRNA-HA Vaccine 2 | EXPERIMENTAL | Participants will receive single dose of TIV mRNA-HA Vaccine 2 |
| Group 10 - QIV-SD | ACTIVE_COMPARATOR | Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only) |
| Group 11 - QIV-HD | ACTIVE_COMPARATOR | Participants will receive single dose of QIV-HD vaccine |
| Name | Type | Description |
|---|---|---|
| Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 | BIOLOGICAL | * Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection |
| TIV mRNA-neuraminidase (NA) | BIOLOGICAL | * Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection |
| TIV mRNA-HA Vaccine 2 | BIOLOGICAL | * Pharmaceutical form: solution for injection 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 Vaccine High Dose | BIOLOGICAL | * Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection |
Inclusion Criteria: * Participant aged 50 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 fem...