Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414

Cunliffe, Nigel; Zaman, Khalequ; Rodrigo, Carlos; Debrus, Serge; Benninghoff, Bernd; Pemmaraju Venkata, Suryakiran; Han, Htay-Htay

doi:10.1186/s12887-014-0295-2

Table 1 Summary of the studies included

From: Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414

Region	Countries	Study	Phase and design	Number of doses and Dosing schedule	Total number of enrolled infants	Number of infants in the placebo group	Reference
Africa	South Africa	444563/013 (Rota-013)	Phase II, randomized, double-blind, placebo-controlled	2 or 3 doses; 0,1,2 month	475	96	-
	South Africa	444563/022 (Rota-022)	Phase II, randomized, double-blind, placebo-controlled	3 doses; 0,1,2 month	100	50	[15]
	South Africa, Malawi	102248 (Rota-037)	Phase III, randomized, double-blind, placebo-controlled	2 or 3 doses; 0,1,2 month	4939	1641	[16]
Asia	Korea	103478 (Rota-041)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,2 month	161	52	[17]
	India	103792 (Rota-044)	Phase IIIb, randomized, double-blind, placebo-controlled	2 doses; 0,1 month	363	181	[18]
	Bangladesh	103992 (Rota-045)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,1 month	300	98	[19]
	Singapore, Hong Kong, Taiwan	444563/028/029/030 (Rota-028, −029, −030)	Phase III, randomized, double-blind, placebo-controlled	2 doses; 0,1 or 2 month	10,708	5349	[9]
Latin America	Brazil, Mexico and Venezuela	444563/006 (Rota 006)	Phase IIb, randomized, double-blind and placebo-controlled trial	2 or 3 doses; 0,2 or 0,2,4 month schedule	2155	537	[20]
	Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela	444563/023 (Rota 023)	Phase III, randomized, double-blind, placebo-controlled	2 doses; 0,1-2 month	20,169	10,010	[21]
	Mexico, Colombia, Peru	444563/033 (Rota-033)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,2 month	854	124	-
	Dominican Republic	106260 (Rota-052)	Phase IIIb, randomized, double-blind, placebo-controlled	2 doses; 0,2 month schedule	200	100	[22]
Europe	Finland	444563/003* (Rota-003)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,2 month schedule	192	16	[23]
	Finland	104480 (Rota-048)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,1 month	250	50	[12]
	Finland, Czech Republic, France, Germany, Italy, Spain	102247 (Rota-036)	Phase IIIb, randomized, double-blind, placebo-controlled	2 doses; 0,1-2 month schedule	3994	1348	[7]
	France, Portugal, Poland and Spain	106481 (Rota-054)	Phase IIIb, randomized, double-blind, placebo-controlled	2 doses; 0,1-2 month schedule	1009	339	[11]
North America	United States and Canada	444563/005** (Rota 005)	Phase II, randomized, double-blind, placebo-controlled	2 doses; 0,2 month schedule	529	108	[24]

*= Rota-003 was a dose escalation study with vaccines containing 10^5.3, 10^5.6 and 10^6.6 CCID₅₀ of RIX4414 strain. Here were are presenting the results of the placebo group whose corresponding vaccine contained 10^6.6 CCID₅₀ of RIX4414 strain.
**= Rota-005 used vaccines containing 10^5.6 and 10^6.8 CCID₅₀ of RIX4414 strain. Here were are presenting the results of the placebo group whose corresponding vaccine contained 10^6.8CCID₅₀ of RIX4414 strain.

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ISSN: 1471-2431

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