Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational hMPV/RSV vaccine · 1 trial · 2 indications
Number of participants reporting immediate unsolicited systemic AEs
Number of participants reporting solicited injection site and systemic reactions
Number of participants reporting unsolicited AEs
Number of participants reporting MAAEs
Number of participants reporting SAEs and AESIs
Number of participants reporting related SAEs, related AESIs, and fatal SAEs
Number of participants with out-of-range biological tests
Number of participants with out-of-range biological tests
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as geometric mean titers (GMTs)
| Arm | Type | Description |
|---|---|---|
| Group A Stage 1 Sentinel Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation A |
| Group B Stage 1 Sentinel Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation B |
| Group C Stage 1 Sentinel Cohort | PLACEBO_COMPARATOR | 1 IM injection of placebo |
| Group 1 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation C |
| Group 2 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation D |
| Group 3 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation E |
| Group 4 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation F |
| Group 5 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation G |
| Group 6 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation A |
| Group 7 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation B |
| Group 8 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation H |
| Group 9 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation I |
| Group 10 Stage 1 Main Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV/RSV vaccine formulation J |
| Group 11 Stage 1 Main Cohort | PLACEBO_COMPARATOR | 1 IM injection of placebo |
| Group X Stage 2 Expansion Cohort | EXPERIMENTAL | 1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort |
| Group 12 Stage 2 Expansion Cohort | EXPERIMENTAL | 1 IM injection of investigational RSV monovalent vaccine |
| Group 13 Stage 2 Expansion Cohort | EXPERIMENTAL | 1 IM injection of investigational hMPV monovalent vaccine |
| Group 14 Stage 2 Expansion Cohort | EXPERIMENTAL | 1 IM injection of licensed RSV vaccine |
| Group 15 Stage 2 Booster Cohort | EXPERIMENTAL | 1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort |
| Name | Type | Description |
|---|---|---|
| Investigational hMPV/RSV vaccine | BIOLOGICAL | Investigational hMPV/RSV vaccine administered intramuscularly |
| Investigational hMPV vaccine (monovalent) | BIOLOGICAL | Investigational hMPV vaccine (monovalent) administered intramuscularly |
| Investigational RSV vaccine (monovalent) | BIOLOGICAL | Investigational RSV vaccine (monovalent) administered intramuscularly |
| Licensed RSV Vaccine | BIOLOGICAL | Licensed RSV vaccine administered intramuscularly |
| Placebo | BIOLOGICAL | Placebo administered intramuscularly |
| Investigational RSV+hMPV vaccine | BIOLOGICAL | Investigational RSV+hMPV vaccine administered intramuscularly |
Inclusion Criteria: * Aged 60 years or older on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or...
The investigational hMPV/RSV vaccine is a Sanofi vaccine candidate designed to immunize against human metapneumovirus and respiratory syncytial virus. It is an mRNA vaccine encapsulated in a lipid nanoparticle formulation. It is being studied in adults aged 60 years and older and remains in clinical development.
It is being developed for immunization against human metapneumovirus and respiratory syncytial virus in adults aged 60 years and older. The Phase 1 trial lists human metapneumovirus immunization and respiratory syncytial virus immunization as its conditions. It is not an approved product.
Sanofi, which trades under the ticker SNY, is developing the investigational hMPV/RSV vaccine. The candidate is an mRNA vaccine encapsulated in a lipid nanoparticle formulation. Sanofi is running the clinical program in the United States.
The investigational hMPV/RSV vaccine is in Phase 1 clinical development. It has not been approved by the FDA and remains investigational. One Phase 1 trial is active, and no trials for this candidate have been completed.
It is being studied in trial NCT06686654, titled a study of a human metapneumovirus/respiratory syncytial virus mRNA vaccine candidate encapsulated in a lipid nanoparticle-based formulation in adults aged 60 years and older. The trial is active but not recruiting, is randomized, double-blind, and placebo-controlled, and has enrolled 1,530 participants in the United States.