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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05101486 | A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years | PHASE3 | COMPLETED | 755 | — | — | Nov 1, 2021 | Sep 20, 2022 | May 25, 2025 | 13 | United States |
| NCT05083585 | A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old | PHASE3 | COMPLETED | 250 | — | — | Oct 8, 2021 | Sep 22, 2022 | May 25, 2025 | 9 | United States |
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
| Arm | Type | Description |
|---|---|---|
| Group 1: Ad26.RSV.PreF-based Vaccine | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot). |
| Group 2: Ad26.RSV.PreF-based Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1). |
| Group 3: Ad26.RSV.PreF-based Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2). |
| Group 1: Phase 3 Clinical Trial Material (CTM) | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM. |
| Group 2: Phase 2b CTM | EXPERIMENTAL | Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM. |
| Name | Type | Description |
|---|---|---|
| Ad26.RSV.PreF-based Vaccine | BIOLOGICAL | Ad26.RSV.PreF-based Vaccine will be administered as single IM injection. |
Inclusion Criteria: * Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods * From the time of vaccination through 3 months after vaccination, ...