GSK reports additional data for malaria vaccine

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reported data on Friday from a group of infants aged 6-12 weeks in a Phase III trial evaluating its RTS,S vaccine to prevent malaria infection. In the per protocol (PP) population of 6,003 infants who received all three doses of RTS,S, the vaccine significantly reduced the incidence of clinical malaria, a co-primary endpoint, over a 12-month period following vaccination by 31.3% compared to the non-malaria comparator vaccine group (p<0.001). In the PP population, the vaccine also significantly reduced the incidence of severe malaria, a co-primary endpoint, over a 12-month period following vaccination by 36.6% compared to control (p=0.02). The vaccine reduced the incidence of clinical malaria by 30.1% (p<0.001) and severe malaria by 26% (p=0.09) vs. control in the intent-to-treat (ITT) population (n=6,537).

The double-blind, African Phase III trial has enrolled 15,460 children in two age categories -- 6-12 weeks of age and 5-17 months of age -- to receive a non-malaria comparator vaccine or three doses of RTS,S given at one-month intervals with or without a booster dose given 18 months after the third dose. Data were published in the New England Journal of Medicine. ...