Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1 · 1 trial · 2 indications
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...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1 is an investigational mRNA-based influenza vaccine developed by Sanofi. It is designed to express hemagglutinin antigens from three influenza strains to stimulate an immune response against seasonal influenza. It is a preventive vaccine candidate, not a treatment for existing infection, and is being studied in adults 50 years of age and older.
Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1 is being developed for the prevention of influenza in adults. Its Phase 1 study enrolled healthy volunteers aged 50 years and older in the United States and Australia. The vaccine targets three influenza hemagglutinin strains, consistent with the trivalent design used in seasonal influenza immunization.
Sanofi develops Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is running the clinical program for this mRNA influenza vaccine candidate.
Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1 is in Phase 1 clinical development. Its single Phase 1 trial has been completed. The vaccine is investigational and has not been approved by the FDA for any indication.
Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1 has been studied in one Phase 1 trial, NCT06744205, titled a study on the safety and immunogenicity of hexavalent influenza mRNA vaccine in adult participants 50 years of age and older. The trial enrolled 1,162 participants across the United States and Australia, was randomized, double blind, and active controlled, and is now completed.