BACKGROUND: The RTS,S/AS01(E) malaria candidate vaccine is being developed for 
immunization of African infants through the Expanded Program of Immunization 
(EPI).
METHODS: This phase 2, randomized, open, controlled trial conducted in Ghana, 
Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01(E) 
when coadministered with EPI vaccines. Five hundred eleven infants were 
randomized to receive RTS,S/AS01(E) at 0, 1, and 2 months (in 3 doses with 
diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B 
[HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), 
RTS,S/AS01(E) at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose 
with measles and yellow fever), or EPI vaccines only.
RESULTS: The occurrences of serious adverse events were balanced across groups; 
none were vaccine-related. One child from the control group died. Mild to 
moderate fever and diaper dermatitis occurred more frequently in the 
RTS,S/AS01(E) coadministration groups. RTS,S/AS01(E) generated high 
anti-circumsporozoite protein and anti-hepatitis B surface antigen antibody 
levels. Regarding EPI vaccine responses upon coadministration when considering 
both immunization schedules, despite a tendency toward lower geometric mean 
titers to some EPI antigens, predefined noninferiority criteria were met for all 
EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01(E) 
at 0, 1, and 2 months. However, when antibody levels at screening were taken 
into account, the rates of response to polio 3 antigens were comparable between 
groups.
CONCLUSION: RTS,S/AS01(E) integrated in the EPI showed a favorable safety and 
immunogenicity evaluation. Trial registration. ClinicalTrials.gov identifier: 
NCT00436007 . GlaxoSmithKline study ID number: 106369 (Malaria-050).