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 4 Comparison of PP and MITT Analyses for RVGE Hospitalizations and Emergency Department (ED) Visits by Serotype

	PP Analysis			MITT Analysis
	RV5	Placebo	% Rate Reduction (95% CI)	RV5	Placebo	% Rate Reduction (95% CI)
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
G1	624	721		889	1006
G2	628	734		904	1050
G3	629	740		903	1062
G4	629	740		905	1063
G9	629	741		905	1065
Infants contributing to the analysis
G1	28645	28479		33136	32984
G2	28641	28466		33121	32940
G3	28640	28460		33122	32928
G4	28640	28460		33120	32927
G9	28640	28459		33120	32925
Results ^c
G1	16 (0.9)	328 (18.3)	95.1 (91.6, 97.1)	32 (1.1)	414 (14.6)	92.3 (88.2, 95.0)
G2	1 (0.1)	8 (0.4)	87.6 (<0, 98.5)	1 (0.0)	12 (0.4)	91.7 (34.7, 99.0)
G3	1 (0.1)	15 (0.8)	93.4 (49.4, 99.1)	3 (0.1)	20 (0.7)	85.1 (49.6, 95.6)
G4	2 (0.1)	18 (1.0)	89.1 (52.0, 97.5)	2 (0.1)	20 (0.7)	90.1 (57.2, 97.7)
G9^d	0 (0.0)	14 (0.8)	100 (69.6, 100)	2 (0.1)	25 (0.9)	92.1 (66.1, 98.2)

^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 numbers in the RV5 and Placebo columns represent the number (rate) of events; the rates reflect the incidence density expressed as the annual number of events per 1000 person-years
^d The number of hospitalizations and ED visits among placebo recipients for the per-protocol population has been revised since the NEJM publication. One additional healthcare encounter in the placebo group was identified after the NEJM publication [10]

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