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Early trials of the RTS,S/AS01 malaria vaccine have shown approximately 50% efficacy (JW Infect Dis Oct 19 2011). Now, this vaccine is being evaluated in a manufacturer-sponsored, double-blind, multicenter, phase III trial in Africa, among children in two age groups: 6 to 12 weeks and 5 to 17 months.
Children at 11 centers in seven African countries (6537 in the younger age group; 8923 in the older group) were randomized to receive three intramuscular doses of RTS,S/AS01 or a comparator vaccine at monthly intervals. In the younger children, the comparator vaccine was meningococcal C conjugate vaccine; in the older group, it was rabies vaccine.
In an interim (12-month) efficacy analysis conducted among the first 6000 children enrolled in the o…