A Phase III, double blind (observer blind), randomized controlled multicentre 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.
This is a Phase III study of GSK Biologicals candidate malaria vaccine RTS, S/AS01E which has been designed to address the key safety and efficacy information required for vaccine licensure.
In addition, other disease endpoints that allow the evaluation of the full public health impact and cost effectiveness of vaccine implementation are included.
Efficacy co-primary objectives: Efficacy against clinical malaria disease when primary immunization starts at 6-12 weeks, or 5-17 months of age.
Efficacy against severe malaria disease: To evaluate the protective efficacy of RTS, S/AS01E on a primary schedule with and without booster dose against severe malaria disease.
Efficacy: Duration of efficacy of a primary course and the role of a boster, Efficacy under different transmission settings, Efficacy against secondary case definitions of clinical malaria disease.|
Safety objective: Safety of a primary course booster close.
Immunogenicity objectives: immunogenicity of a primary course, a booster dose and polio stereotypes 1, 2 and 3.
Safety and immunogenicity in special subgroups: HIV and malnutrition.
