Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06237296 | Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older | PHASE1 | COMPLETED | 558 | — | — | Jan 23, 2024 | Feb 11, 2025 | Sep 11, 2025 | 17 | United States, Australia |
| NCT06134648 | Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate | PHASE1 | COMPLETED | 646 | — | — | Nov 1, 2023 | Feb 27, 2026 | Mar 12, 2026 | 13 | United States, Puerto Rico |
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. ...