University of Witwatersrand VIDA
SITE-VAX-014-003
RecruitingHealthy · 33
Enrolled
74
Screen fail %
15.6%
Open queries
9
Risk score
36
Months active
22
Study assignment
- Sponsor
- Stellis Vaccines
- Study code
- VAX-014
- Therapeutic area
- Vaccines / Infectious disease
- Indication
- Respiratory syncytial virus in older adults
Staffing
- Principal investigator
- Dr. Thandi Mokoena
- Site coordinator
- Johann Site Coordinator
- Monitor (CRA)
- CRA — South Africa region
Recent activity
| Date | Kind | Summary | Actor |
|---|---|---|---|
| 2026-10-25 | Enrollment | New subject enrolled (Subject 0042) | Dr. Thandi Mokoena |
| 2026-10-22 | Monitoring visit | CRA monitoring visit completed; 12 SDV checks closed | CRA team |
| 2026-10-18 | Query resolved | Two open queries resolved by site coordinator | Site coordinator |
| 2026-10-13 | Signature | Protocol amendment v3 signed by PI | Dr. Thandi Mokoena |
| 2026-10-06 | Query opened | Data management opened query on AE form (Subject 0031) | Data management |
Deviation history
| Date | Severity | Title | CAPA | Status |
|---|---|---|---|---|
| 2026-09-27 | minor | Informed consent re-consent window exceeded | Site retrained on v3 protocol; tracker added. | open |
| 2026-08-28 | major | Visit window exceeded by >7 days for two subjects | CRA flagged subjects; both within protocol-allowed window after review. | under-review |