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Live attenuated rotavirus vaccine administered in two oral doses is recommended in Europe for infants. In an industry-sponsored, randomized, placebo-controlled study sponsored by the manufacturer of Rotarix, investigators examined the vaccine’s efficacy in six countries during two epidemic seasons (2004 and 2006) in 3874 infants (age range, 6–14 weeks): 2572 infants received two doses of the vaccine, and 1302 received placebo with other routine immunizations.
During the two seasons, rotavirus was detected in stool samples from 289 gastroenteritis episodes. During the first season, rotavirus gastroenteritis of any severity occurred in 0.9% of rotavirus-immunized infants and in 7.2% of controls (vaccine efficacy, 87%). The vaccine efficacy dur…