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RxTrials Institute Drug Pipeline Alert
> Emergent BioSolutions’ Typhoid Candidate Achieves Endpoints in Trial
RxTrials Institute Drug Pipeline Alert
Oct. 11, 2007
| Vol.
5 No.
200
Emergent BioSolutions’ Typhoid Candidate Achieves Endpoints in Trial
Emergent BioSolutions reported its single-dose, drinkable typhoid vaccine candidate achieved the study endpoints for safety and immunogenicity. In the randomized, placebo-controlled Phase II clinical study, which recruited Vietnamese children between the ages of 5 and 14, a total of 101 subjects received the vaccine candidate and 50 children received placebo. The vaccine was immunogenic and met the predefined criterion of an overall immune response rate of greater than 50 percent. The vaccine induced significantly higher antibody concentrations, indicative of systemic responses, in children in the vaccine group compared with the placebo control group. It was well tolerated with no serious adverse events or deaths reported, and no subjects withdrew due to adverse events, Emergent said. |
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