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Intercell Initiates Efficacy Trial For TD Vaccine System In Asia
- Publisher:
- Publication:2010/1/6
To evaluate efficacy and enterotoxigenic E coli incidence of vaccinated European travelers to India
Intercell has started a phase II study in India as part of its clinical development program, for the investigational travelers' diarrhea (TD) vaccine system. This placebo controlled field study, with vaccinated travelers from the EU to India, will test the efficacy of the Intercell TD vaccine. The primary objective of this clinical trial is prevention of all moderate/severe diarrheal cases in which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enroll approximately 800 travelers from the UK and Germany.
The results are expected by the end of 2010.
Study is designed to complement ongoing phase III pivotal efficacy trial of European travelers to Latin America - data expected to further support licensure for prevention of enterotoxigenic E coli (ETEC) disease in travelers to multiple risk regions.
Thomas Lingelbach, COO of Intercell and CEO of Intercell USA, said: "The start of our next important TD trial underlines our dynamic route to licensure and earliest possible commercialization with our marketing partner GSK. Positive results from this study can greatly support our expected product target profile."
Source:web of PBR