Bhandari, Nita ; Sharma, Pooja ; Glass, Roger I. ; Ray, Pratima ; Greenberg, Harry ; Taneja, Sunita ; Saksena, Manju ; Rao, C. Durga ; Gentsch, Jon R. ; Parashar, Umesh ; Maldonado, Yvonne ; Ward, Richard L. ; Bhan, M. K. (2006) Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial Vaccine, 24 (31-32). pp. 5817-5823. ISSN 0264-410X
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Official URL: http://www.sciencedirect.com/science/article/pii/S...
Related URL: http://dx.doi.org/10.1016/j.vaccine.2006.05.001
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 (105FFu (florescence focus units)), I321 (105FFu) 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.
| Item Type: | Article |
|---|---|
| Source: | Copyright of this article belongs to Elsevier Science. |
| Keywords: | Rotavirus Vaccine; Safety; Immunogenicity |
| ID Code: | 99849 |
| Deposited On: | 27 Nov 2016 13:37 |
| Last Modified: | 28 Nov 2016 06:31 |
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