Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5)

Table 3 Comparison of PP and MITT Analyses for RVGE Healthcare Encounters by Type of Encounter

	PP Analysis			MITT Analysis
	RV5	Placebo	% Rate Reduction (95% CI)	RV5	Placebo	% Rate Reduction (95% CI)
Hospitalizations and ED Visits
Infants vaccinated	34035	34003		34035	34003
Protocol violators ^a	4740	4778		****	****
Infants with no follow-up ^b	26	25		10	13
Infants classified as not-evaluable	623	712		862	975
Infants contributing to the analysis	28646	28488		33163	33015
No. (rate) of hospitalizations & ED visits^c	20 (1.1)	369 (20.6)	94.5 (91.2, 96.6)	58 (2.0)	522 (18.4)	88.9 (84.9, 91.9)
No. (rate) of hospitalizations^c	6 (0.3)	144 (8.0)	95.8 (90.5, 98.2)	16 (0.6)	215 (7.6)	92.6 (87.3, 95.7)
No. (rate) of ED visits^c	14 (0.8)	225 (12.6)	93.7 (88.8, 96.5)	42 (1.5)	307 (10.8)	86.4 (80.2, 90.6)
Office Visits
Infants vaccinated	2834	2839		2834	2839
Protocol violators ^a	295	271		****	****
Infants with no follow-up ^b	11	6		2	4
Infants classified as not-evaluable	355	284		429	403
Infants contributing to the analysis	2173	2278		2403	2432
No. (rate) of office visits^c	13 (5.5)	98 (39.7)	86.0 (73.9, 92.5)	21(6.6)	123 (38.0)	82.6 (71.6, 89.3)

^a Subjects who received a vial where a temperature excursion occurred, subjects who had less than 3 vaccinations or less than 28 days between vaccinations, and subjects who were cross-treated or prematurely unblinded
^b In the PP analysis follow-up begins 14 days after dose 3; in the MITT analysis follow-up begins after dose 1
^c The RV5 and Placebo columns represent the number (rate) of events; the rates reflect the incidence density expressed as the annual number of events

ISSN: 1471-2431