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Phase III Trial of RTS,S (RTSS)

Full Title: 
A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease caused by P. falciparum infection, across diverse malaria transmission settings in Africa.
Other Investigator(s): 
Patricia Njuguna

 

This is a large multi-centre phase III trial of GloxoSmithKiline Biologicals candidate malaria vaccine, RTS,S (RTSS). This study will include up to 16,000 children Africa wide in 7 countries. This is the leading malaria vaccine which has shown promise of efficacy in earlier studies and may lead to licensure by 2013 if the results of the current trial are favourable.

This study is to evaluate the efficacy and safety of the GSK candidate vaccine with a view to licensure. It will include at our site 600 children aged 5-17 months and 379 children aged 6-12 weeks. They will be randomized to 3 arms with a 0,1,2 and booster at 20 months: vaccine-vaccine, vaccine-comparator and comparator-comparator. They will be followed up for 32 months.  Evaluation for other public health endpoints will be included. This work is done with the help of GSK Biologicals, Malaria Vaccine Initiative and the other participating sites in the rest of Africa.