Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa

Table 1 Treatment groups and vaccination schedule

	Primary vaccination: 0, 1, 2 months	Booster vaccination: month 20
Children 5-17 months of age
"R3R" group	RTS,S/AS01	RTS,S/AS01
"R3C" group	RTS,S/AS01	Control (MCC vaccine)
"C3C" group	Control (rabies vaccine)	Control (MCC vaccine)
Children 6-12 weeks of age
"R3R" group	RTS,S/AS01 + DTPwHepB/Hib + OPV	RTS,S/AS01 + OPV
"R3C" group	RTS,S/AS01 + DTPwHepB/Hib + OPV	Control (MCC vaccine) + OPV
"C3C" group	Control (MCC vaccine) + DTPwHepB/Hib + OPV	Control (MCC vaccine) + OPV

MCC: Meningococcal C conjugate vaccine - Meningitec™ (Wyeth), NeisVac-C™ (Baxter) or Menjugate™ (Novartis)
Cell culture rabies vaccine - human diploid cell rabies vaccine (Imovax™, Sanofi Pasteur), purified chick embryo cell culture vaccine (Rabipur™/Rabavert™, Novartis) or purified Vero cell culture rabies vaccine (VeroRab™, Sanofi Pasteur)
DTPwHepB/Hib - Tritanrix HepB™ and Hiberix™ (GSK Biologicals)
OPV: Oral polio vaccine - Polio Sabin™ (GSK Biologicals)
Each child will receive all three doses of rabies vaccine or MCC vaccine from the same manufacturer

ISSN: 1475-2875