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.