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. Author manuscript; available in PMC: 2016 Dec 30.
Published in final edited form as: N Engl J Med. 2016 Jun 30;374(26):2519–2529. doi: 10.1056/NEJMoa1515257

Table 1. Vaccine Efficacy.*.

Variable RTS,S/AS01 Vaccine Control Efficacy (95% CI) P Value
No. of Participants No. of Events Person-Yr at Risk Event Rate No. of Participants No. of Events Person-Yr at Risk Event Rate
Intention-to-treat cohort
First episode, Cox regression
     >2500 parasites/mm3 223   150   668.0 0.22 224   157   501.6 0.31 27.0 (8.5 to 41.8)   0.006
     >0 parasites/mm3 223   158   622.9 0.25 224   163   470.1 0.35 25.6 (7.2 to 40.3)   0.009
Multiple episodes, negative binomial regression
     >2500 parasites/mm3 223 1002 1372.8 0.73 224   992 1282.5 0.77   4.4 (−17.0 to 21.9)   0.66
     >0 parasites/mm3 223 1157 1372.8 0.84 224 1164 1282.5 0.91   4.7 (−15.3 to 21.3)   0.62
Per-protocol cohort
First episode, Cox regression
     >2500 parasites/mm3 209   139   605.6 0.22 206   145   440.3 0.33 33.8 (16.4 to 47.6)   0.001
     >0 parasites/mm3 209   144   567.8 0.25 206   151   412.5 0.37 34.1 (17.1 to 45.6) <0.001
Multiple episodes, negative binomial regression
     >2500 parasites/mm3 209   889 1223.6 0.73 206   844 1109.2 0.76   7.0 (−14.5 to 24.6)   0.52
     >0 parasites/mm3 209 1021 1223.6 0.83 206   990 1109.2 0.89   8.6 (−11.4 to 25.0)   0.37
*

The control group received a rabies vaccine. All clinical malaria cases were detected by active case detection or passive case detection. Vaccine efficacy was defined as 1 minus the hazard ratio or the incidence-rate ratio, then multiplied by 100. P values were calculated with the use of a Cox proportional-hazards model for first episodes and negative binomial regression for multiple episodes.