This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)

Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

Among young children, live attenuated vaccine had significantly better efficacy than inactivated vaccine. An evaluation of the risks and benefits indicates that live attenuated vaccine should be a highly effective, safe vaccine for children 12 to 59 months of age who do not have a history of asthma or wheezing. (ClinicalTrials.gov number, NCT00128167 [ClinicalTrials.gov].).

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65 episodes of rotavirus diarrhoea, detected during a longitudinal follow-up of 336 infants from birth to 24-32 months of age, were analyzed for clinical symptoms. Rotavirus gastroenteritis was characterized by watery diarrhoea, vomiting (particularly in older children), fever and dehydration. A 0-20 point numerical score was devised according to the distribution of clinical features in the patients. Using this system, the mean severity score for the 65 episodes of rotavirus diarrhoea was 11.0 +/- 3.7 as compared to 5.6 +/- 3.2 for the 183 episodes of non-rotavirus diarrhoea in the same population (p less than 0.0001, t-test). The 20 point score is proposed for analysis of efficacy studies of candidate rotavirus vaccines.

NCT00534248.

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