Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIV mRNA-neuraminidase · 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...
TIV mRNA-neuraminidase is an investigational messenger RNA (mRNA) vaccine being developed for the prevention of influenza. It is designed to elicit an immune response against the neuraminidase protein of influenza viruses. The vaccine is intended for use in adults, with clinical studies focusing on participants 50 years of age and older.
TIV mRNA-neuraminidase is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this mRNA-based influenza vaccine candidate.
TIV mRNA-neuraminidase is currently in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under evaluation for safety and immune response in adult participants.
TIV mRNA-neuraminidase has been studied in one clinical trial registered under the identifier NCT06744205. This Phase 1 study, titled 'A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older,' was conducted in the United States and Australia with 1,162 participants. The trial has been completed.
TIV mRNA-neuraminidase is an mRNA vaccine that works by instructing cells to produce the neuraminidase protein, a key surface antigen of influenza viruses. This protein is not naturally present in the body, so the immune system recognizes it as foreign and mounts a protective antibody response. The vaccine is designed to generate immunity against influenza.
TIV mRNA-neuraminidase is associated with a hexavalent influenza mRNA vaccine candidate. The clinical trial NCT06744205 evaluates a hexavalent influenza mRNA vaccine, which targets six components of the influenza virus, including neuraminidase. TIV mRNA-neuraminidase refers specifically to the neuraminidase component of this vaccine approach.