The role of pre-existing cross-reactive antibodies in determining the efficacy of vaccination in humans: study protocol for a randomized controlled trial

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)	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)
Physical examination		×	×	×	×	x	×	×
Vital signs^a	×	×	×	×	×	x	×	×
Assessment for clinical symptoms (local and general symptoms)		×	×	×	×	x
Blood sampling in relation to YF17D vaccination	×		×	×	×		×	×
Adverse events^b	×		×	×	×	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.

ISSN: 1745-6215