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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07071558 | Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age | PHASE1 | COMPLETED | 240 | — | — | Jul 14, 2025 | Mar 17, 2026 | Apr 28, 2026 | 6 | Australia |
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 unsolicited AEs
Number of participants experiencing SAEs and AESIs
number of participants with out-of-range biological tests
| Arm | Type | Description |
|---|---|---|
| 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 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 18 to 49 years on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies: * Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopau...