Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV mRNA LNP 1 · 1 trial · 3 indications
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Number of participants experiencing unsolicited AEs
Number of participants experiencing MAAEs
Throughout study (up to approximately 6 months)
Number of participants experiencing AESIs
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
| Arm | Type | Description |
|---|---|---|
| RSV/hMPV mRNA / LNP 1 Group 1 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1. |
| RSV/hMPV mRNA / LNP 1 Group 2 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2. |
| RSV/hMPV mRNA / LNP 1 Group 3 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3. |
| RSV/hMPV mRNA / LNP 2 Group 4 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1. |
| RSV mRNA / LNP 1 Group 5 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1. |
| hMPV mRNA / LNP 1 Group 6 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1. |
| RSV/hMPV mRNA / LNP 1 Group 7 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4. |
| Name | Type | Description |
|---|---|---|
| RSV/hMPV mRNA LNP 1 | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| RSV/hMPV mRNA LNP 2 | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| RSV mRNA LNP 1 | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| hMPV mRNA LNP 1 | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
Inclusion Criteria: -Informed consent form (ICF) has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. ...
RSV mRNA LNP 1 is an investigational RNA therapy vaccine developed by Sanofi for the prevention of respiratory syncytial virus infection. It is designed to prevent RSV and/or human metapneumovirus in adults. It is in Phase 1 clinical development and has not been approved by the FDA.
RSV mRNA LNP 1 is being studied for the prevention of respiratory syncytial virus infection, and the related trial also evaluates prevention of human metapneumovirus. The Phase 1 study enrolled healthy volunteers aged 18 to 49 years and 60 years and older.
RSV mRNA LNP 1 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the Phase 1 clinical trial evaluating this investigational mRNA vaccine for RSV and human metapneumovirus prevention.
RSV mRNA LNP 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The single Phase 1 trial has been completed, with no active trials currently ongoing.
RSV mRNA LNP 1 has been evaluated in one Phase 1 clinical trial, NCT06237296, titled a study of the safety and immune response of an investigational mRNA vaccine for the prevention of respiratory syncytial virus and/or human metapneumovirus. The trial enrolled 558 participants across the United States and Australia and is completed.
The Phase 1 trial NCT06237296 was a randomized, double-blind, controlled study enrolling 558 healthy volunteers aged 18 to 49 years and 60 years and older. It assessed safety and immune response for prevention of respiratory syncytial virus and/or human metapneumovirus and was conducted in the United States and Australia.