Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination: A Phase 3 Randomized, Controlled Trial in Children and Young Infants at 11 African Sites
Figure 3
CONSORT diagram of infants aged 6–12 wk at enrollment followed until 18 mo post-vaccination.
aScreening data had not been reported before the database freeze for the analysis published in 2011 for 22 infants in the 6–12-wk age category, and these participants were not included in the 2011 CONSORT chart. bOne infant enrolled in the 6–12-wk age category who was reported to have received three doses of study vaccine (RTS,S/AS01 or comparator vaccine) was included in the per-protocol analyses reported previously, but was subsequently found to have received only the first dose of study vaccine. cTwo infants enrolled in the 6–12-wk age category who had been reported as “attending Visit 16 (12 months post dose-3)” in the 2012 CONSORT chart are reported as “migrated/lost to follow-up” in this CONSORT chart. In addition, one infant who was reported as “migrated/lost to follow-up” in the 2012 CONSORT chart has been recorded as “consent withdrawal” in this CONSORT chart [15].