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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01290419 | Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine | PHASE1 | COMPLETED | 150 | — | — | Dec 1, 2010 | Dec 1, 2011 | Mar 8, 2012 | 1 | United States |
This primary outcome will be evaluated through an assessment of the following parameters: * Immediate AEs * Solicited AEs * All SAEs and SNMCs * Vital signs * Laboratory Assessments
| Arm | Type | Description |
|---|---|---|
| A: Dose 1 + adjuvant | EXPERIMENTAL | - |
| B: Dose 2 + adjuvant | EXPERIMENTAL | - |
| C: Dose 3 + adjuvant | EXPERIMENTAL | - |
| D: Dose 3 alone | EXPERIMENTAL | - |
| E: Placebo control | PLACEBO_COMPARATOR | - |
| F: Dose 4 alone | EXPERIMENTAL | - |
| G: Dose 4 +adjuvant | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RSV-F Particle Vaccine | BIOLOGICAL | Dose 1 + adjuvant / dose; Day 0 and Day 30 |
| Placebo | BIOLOGICAL | Placebo; Day 0 and Day 30 |
Inclusion Criteria: * Male or female aged 18 to 49 years inclusive * Ability to provide written informed consent to participate * Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline * Females are required to fulfill o...