GSK's malaria vacc enters Ph III testing

4 June 2009

A Phase III trial of the most clinically-advanced malaria vaccine candidate has been initiated at sites in the Bagamoyo Research and  Training Center of the Ifakara Health Institute in Tanzania. In the  coming months, the trial is expected to start in other countries across  sub-Saharan Africa and will enroll up to 16,000 children and infants.

UK drug major GlaxoSmithKline's product is the first malaria vaccine to  demonstrate promising safety and significant efficacy to warrant  late-stage testing and is the leading candidate in the effort by the  PATH Malaria Vaccine Initiative to develop a vaccine against this  mosquito-borne parasite that kills 900,000 people every year.

Recent Phase II studies showed that, over an eight-month follow-up  period, the GSK vaccine reduced the risk of clinical episodes of malaria  by 53% and has a promising safety and tolerability profile when used  alongside standard infant vaccines. The Phase III trial builds on more  than 10 years of clinical research in Africa, including the first  proof-of-concept study in children in 2004 and a trial in infants in  2007.

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