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 2 Comparison of Baseline Characteristics for PP and MITT Analyses based on the Number of Evaluable Subjects

	PP Analysis		MITT Analysis
	RV5	Placebo	RV5	Placebo
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
Age at Entry - in weeks
Mean	9.8	9.8	9.8	9.8
Median	10	10	10	10
Range	(6-13)	(6-13)	(6-13)	(6-13)
Race - number, %
White	20676 (72.2%)	20653 (72.5%)	23021 (69.4%)	22912 (69.4%)
Black	2230 (7.8%)	2215 (7.8%)	2739 (8.3%)	2761 (8.4%)
Hispanic	3644 (12.7%)	3552 (12.5%)	4721 (14.2%)	4656 (14.1%)
Other	2096 (7.3%)	2068 (7.2%)	2682 (8.1%)	2686 (8.1%)
Gender - number, %
Female	14112 (49.3%)	14131 (49.6%)	16343 (49.3%)	16331 (49.5%)
Male	14534 (50.7%)	14357 (50.4%)	16820 (50.7%)	16684 (50.5%)

^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

ISSN: 1471-2431