Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial

Table 1 Schedule of activities for participants in a single cohort (semester)

		1st semester						Semester break^a		2nd semester
Weeks since allocation (study week)		Wk -1	Wk 1	Wk 2	Wk 3	Wk 4	Etc.	Wk 15	Wk 16	Wk 17	Etc.	Wk 25	Wk 26	Wk 27	Wk 28
Weeks of semester/break		Wk 1	Wk 2	Wk 3	Wk 4	Wk 5	Etc.	Wk 1	Wk 2	Wk 1	Etc.	Wk 8	Wk 9	Wk 10	Wk 11
Enrollment
Information	X	X
Eligibility screen	X	X
Informed consent	X	X
Contraindication screening			X
Allocation			X
Intervention^b
Dose 1			X
Dose 2				X
Dose 3						X
Assessments
Baseline		X
Weekly illness survey (1–26)					X (S1)	X (S2)	X (Etc.)	X (S 13)	X (S 14)	X (S 15)	X (Etc.)	X (S 23)	X (S 24)	X (S 25)	X (S 26)
Solicited adverse events			X	X		X
Unsolicited adverse events			X	X	X	X
Blood collection (efficacy ancillary study)		X (D -7)										X (D 180)
Blood collection (immunology ancillary study)			X (D 0)			X (D 21)		X (D 90)
Study exit															X

^aSome semester breaks are 3 weeks long, in which case Weeks 27 and 28 since allocation will fall in Weeks 9 and 10 of the sixth semester
^bSchedule shown here assumes administration of the first dose in Week 2 and administration of subsequent doses per schedule (day 7 and day 21). If necessary, participants can begin the intervention at any time in the first 12 weeks of the semester

ISSN: 1745-6215