A prospective study of acute diarrhoeal diseases was carried out from April 1990 to September 1992 with the purpose of assessing the immunogenicity, safety and efficacy of a Rhesushuman reassortant rotavirus (-RRV-TV-) vaccine, involving 540 children living in Belém, Pará, Brazil. As half of the children received placebo, this trial provided the opportunity of broadening the knowledge on both clinical and epidemiological aspects of rotavirus infection in the Amazon region. There were 2,789 diarrhoeal episodes during the above mentioned period, of which 86 (3,1%) associated with rotavirus; serotype 1 was the more prevalent, accounting for 67,9% of serotyped strains. Rates of 5,9 and 0,2 episodes of diarrhoea per child/ year were noted for all cases and the rotavirus-related ones, respectively. This agent was the only pathogen found in 70,9% of the 86 rotavirus-related episodes of acute diarrhoea, whereas the most frequent associations involved Giardia intestinalis and enteropathogenic Escherichia coli, accounting for 7,0% and 11,6% of mixed infections, respectively. The monthly rates of rotavirus-related episodes of diarrhoea ranged from 0,8% to 9,6%, reaching the highest peaks during the dry months of the year. Means of clinical severity scores of 9,4 and 5,3 were recorded for the rotavirusrelated episodes of diarrhoea and those of other aetiology, respectively.
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