Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Licensed RSV Vaccine
RSV/hMPV vaccine candidate Dose L · 2 trials · 4 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
Number of participants experiencing related SAEs
Number of participants experiencing related AESIs
Number of participants experiencing fatal SAEs
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)
| 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. |
| Sentinel Cohort: RSV/hMPV Group 0 (Dose L) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: RSV/hMPV Group 1 (Dose A) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: RSV/hMPV Group 2 (Dose B) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: Placebo-Group 3 | PLACEBO_COMPARATOR | Participants will be randomized to receive a single IM injection of placebo |
| Main Cohort: RSV/hMPV Group 1 (Dose A) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Main Cohort: RSV/hMPV Group 2 (Dose B) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Main Cohort: Placebo-Group 3 | PLACEBO_COMPARATOR | Participants will be randomized to receive a single IM injection of placebo |
| Booster Cohort-RSV/hMPV | EXPERIMENTAL | Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort |
| Booster Cohort-Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort |
| 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 |
| RSV/hMPV vaccine candidate Dose L | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| RSV/hMPV vaccine candidate Dose A | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| RSV/hMPV vaccine candidate Dose B | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| Placebo | 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 vaccine formulation 1 dose is an investigational vaccine being developed for the prevention of Respiratory Syncytial Virus (RSV) infection and immunization. It is also being studied for use against Human Metapneumovirus (hMPV) infection. The vaccine is intended for healthy adults, including those aged 18 to 49 years and older adults aged 60 years and above.
RSV vaccine formulation 1 dose is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The vaccine is currently in Phase 1 clinical development for the prevention of RSV infection and related respiratory conditions.
RSV vaccine formulation 1 dose is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied in early-stage trials to evaluate its safety and immune response in healthy participants, including adults aged 18 to 49 years and older adults aged 60 years and above.
RSV vaccine formulation 1 dose has been studied in several Phase 1 clinical trials. These include NCT06134648, which evaluated a combined RSV and Human Metapneumovirus vaccine candidate in 646 participants aged 60 years and older in the United States and Puerto Rico. Other trials include NCT06237296, NCT06583031, and NCT07071558, all completed, with total enrollment across trials of 2640 participants.
Yes, RSV vaccine formulation 1 dose is also known as Licensed RSV Vaccine and RSV+HMPV vaccine. These alternative names refer to the same investigational vaccine candidate being developed by Sanofi for the prevention of RSV and Human Metapneumovirus infections. The vaccine is currently in Phase 1 clinical trials and is not yet licensed.
RSV vaccine formulation 1 dose is a vaccine designed to stimulate the immune system to produce a protective response against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). By presenting viral antigens, the vaccine aims to generate antibodies and immune memory that can prevent or reduce the severity of RSV and hMPV infections in vaccinated individuals.