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 3 Study objectives

Efficacy	Efficacy against clinical malaria over 1 year in children aged 6-12 weeks at first vaccination (co-administration of DTPwHepB/Hib)¹ Efficacy against clinical malaria over 1 year in children aged 5-17 months at first vaccination¹ Efficacy against severe malaria Prevention of anaemia (incident severe anaemia; prevalent moderate and severe anaemia) Prevention of malaria hospitalization Evolution over time of efficacy following the primary vaccination course Additional benefit of a booster dose Efficacy in different transmission settings Efficacy against parasite prevalence Efficacy against other serious illnesses (medical hospitalization, sepsis and pneumonia) Efficacy against fatal malaria and all-cause mortality Effect on growth Gender-specific efficacy²
Immunogenicity	Immunogenicity of a primary vaccination course Immunogenicity of a booster dose Immunological correlates of protection Immunogenicity of the oral polio vaccine when co-administered with RTS,S/AS01
Safety	Safety of a primary vaccination course Safety of a booster dose
Special populations	Immunogenicity and safety in HIV-infected children Immunogenicity and safety in low weight for age children

¹ Represent the primary objectives
² If important differences in the co-primary objectives are observed between boys and girls, all primary and secondary efficacy and immunogenicity endpoints will be presented separately for boys and girls

ISSN: 1475-2875