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Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial VACCINE Bhandari, N., Sharma, P., Glass, R. I., Ray, P., Greenberg, H., Taneja, S., Saksena, M., Rao, C. D., Gentsch, J. R., Parashar, U., Maldonado, Y., Ward, R. L., Bhan, M. K. 2006; 24 (31-32): 5817-5823

Abstract

We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.

View details for DOI 10.1016/j.vaccine.2006.05.001

View details for Web of Science ID 000239470000008

View details for PubMedID 16735085