Table 3.
Blood sampling schedule for study arms 1, 2, 3
| Visit 4 | Visit 5 - 1 day after | Visit 6 - 3 days after (+1 day) | Visit 7 - 1 week after (±2 days) | Visit 8 - 15 days after (+2 days) | Visit 9 - 1 month after (±5 days) | Visit 10 - 6 months after (±14 days) | ||
|---|---|---|---|---|---|---|---|---|
| Pre-vaccination (any time before dosing) | Post-vaccination (1 hour) | |||||||
| Physical examination | × | × | × | × | x | × | × | |
| Vital signsa | × | × | × | × | × | x | × | × |
| Assessment for clinical symptoms (local and general symptoms) | × | × | × | × | x | |||
| Blood sampling in relation to YF17D vaccination | × | × | × | × | × | × | ||
| Adverse eventsb | × | × | × | × | x | × | × | |
| Concomitant medications | × | × | × | × | x | × | × | |
aVital signs include temperature (oral and tympanic allowed), blood pressure, pulse rate, and respiratory rate. bClinical Trial Certificate Adverse Events version 4.0 will be used for grading. YF, yellow fever.