KEYWORDS:
rotavirus, acute gastroenteritis, vomiting, diarrhea

BACKGROUND:
RV is the leading cause of dehydrating AGE in infants and children worldwide and a major cause of infant death in developing countries.

OBJECTIVE(S):
To characterize the clinical presentation of RV AGE, we reviewed RV AGE cases in vaccine and placebo groups in 3 clinical trials in healthy infants of live attenuated RV vaccine containing human-bovine (strain WC3) reassortant RV.

METHOD(S):
In study 1, during 1993-1994, 439 U. S. infants, ~2-6 months of age; in study 2, during 1997-98, 731 U. S. infants ~2-4 months of age; and in study 3, during 1998-2000, 1946 Finnish infants ~2-8 months of age were enrolled. We defined a case of RV AGE as 3 or more watery/looser than normal stools within 24-hours and/or forceful vomiting (V) + identification of RV in stool, at least 14 days after Dose 3 of vaccine/placebo.

RESULT(S):
In study 1, 50 infants had RV AGE; 80.0% had V and diarrhea (D), 6.0% had V without D, and 14.0 % had D without V. In study 2, 13 infants had RV AGE; 61.5% had V and D, 23.1% had D without V, and in 15.4% data were incomplete. In study 3 (preliminary data), 115 infants had RV AGE; 74.8% had V and D, 5.2% had V without D, and 20.0% had D without V.

CONCLUSIONS(S):
V was frequent in clinical RV illness, although it may be overestimated because of the case definition. Oral rehydration therapy alone may be insufficient to prevent RV morbidity and mortality.

LEARNING OBJECTIVES:
Understand clinical presentation of rotavirus infection