Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Licensed RSV Vaccine
RSV vaccine formulation 1 dose · 2 trials · 3 indications
nAb titers expressed as geometric mean titers (GMTs)
nAb titers expressed as GMTs
nAb titers expressed as GMTs
nAb titers expressed as GMTs
Number of participants reporting immediate unsolicited systemic AEs
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue and myalgia
Number of participants reporting unsolicited AEs
Number of participants reporting MAAEs
Number of participants reporting SAEs, fatal SAEs and AESIs
Number of participants with biological safety assessment values out of normal range (including shift from baseline values)
Number of participants experiencing immediate AEs
Number of participants experiencing solicited injection site reactions
Number of participants experiencing solicited systemic reactions
Number of participants experiencing SAEs and AESIs
number of participants with out-of-range biological tests
| Arm | Type | Description |
|---|---|---|
| Group 1: RSV + HMPV Vaccine-Dose 1 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio |
| Group 2: RSV + HMPV Vaccine-Dose 2 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio |
| Group 3: RSV + HMPV Vaccine-Dose 3 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio |
| Group 4: RSV + HMPV Vaccine-Dose 4 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio |
| Group 5: RSV + HMPV Vaccine-Dose 5 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio |
| Group 6: RSV + HMPV Vaccine-Dose 6 | EXPERIMENTAL | Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio |
| Group 7: Control Vaccine 1 | ACTIVE_COMPARATOR | Participants will receive control vaccine 1 |
| Group 8: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo |
| Group 9: Control Vaccine 2 | OTHER | Participants will receive control vaccine 2 at a predefined dose and antigen ratio |
| Group 10: Control Vaccine 3 | OTHER | Participants will receive control vaccine 3 at a predefined dose |
| Group 11: Control Vaccine 4 | OTHER | Participants will receive control vaccine 4 at a predefined dose |
| RSV Formulation 1 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 2 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 3 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 4 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 5 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 6 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Control group 1 dose 1 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Control group 2 dose 2 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Name | Type | Description |
|---|---|---|
| RSV+HMPV vaccine | BIOLOGICAL | RSV + HMPV Candidate Vaccine |
| Control Vaccine 3 | BIOLOGICAL | Control Vaccine 3 |
| Control Vaccine 4 | BIOLOGICAL | Control Vaccine 4 |
| Control Vaccine 2 | BIOLOGICAL | Control Vaccine 2 |
| Placebo | OTHER | Placebo |
| Control Vaccine 1 | BIOLOGICAL | Control Vaccine 1 |
| RSV vaccine formulation 1 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 2 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 3 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 4 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 5 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 6 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 7 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
| RSV vaccine formulation 8 dose | BIOLOGICAL | Suspension for injection. Route of administration: IM injection |
Inclusion Criteria: * Aged 60 years or older on the day of inclusion * Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile) Exclusion Criteria: * History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or t...
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.