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GSK's malaria vaccine trials underway

A pivotal phase III trial of GlaxoSmithKline's malaria vaccine candidate is underway in seven African countries

GlaxoSmithKline (GSK) has announced that a pivotal phase III trial of its malaria vaccine candidate is underway in seven African countries - Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.

More than 5,000 children are already enrolled on the trial and researchers expect 16,000 children to be enrolled in total.

The vaccine, known as RTS,S is the first to be designed for use primarily in Africa where more than 80,000 people, predominantly children under five, are killed by malaria each year.

"This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa," said Dr Joe Cohen, co-inventor of RTS,S and vice president of R&D, vaccines for emerging diseases and HIV, at GSK Biologicals.

Two groups of children will receive vaccinations during the trial. The first group, aged between six and 12 weeks, will be vaccinated as part of their routine infant immunisation schedule. The second group consists of children aged five to 17 months. The efficacy of the vaccine in each group will be measured.

"A malaria vaccine could help save countless lives and redefine the future for Africa's children," said Dr Patricia Njuguna, RTS,S principal investigator (KEMRI-Wellcome Trust, Kilifi, Kenya) and chair of the Clinical Trials Partnership Committee, a collaboration of African research institutions, MVI, and GSK Bio that is leading the clinical development of RTS,S. "Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile."

4th November 2009

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