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. Author manuscript; available in PMC: 2009 Mar 13.
Published in final edited form as: N Engl J Med. 2008 Dec 8;359(24):2521–2532. doi: 10.1056/NEJMoa0807381

Table 2. Efficacy of the RTS,S/AS01E Vaccine against Episodes of Clinical Malaria.*.

Episode RTS,S/AS01E Vaccine Rabies Vaccine Adjusted Efficacy Unadjusted Efficacy
No. of
Subjects
No. of
Episodes
Person-Yr
at Risk
Event
Rate
No. of
Subjects
No. of
Episodes
Person-Yr
at Risk
Event
Rate
% (95% CI) P Value % (95% CI) P Value
According-to-protocol analysis
First or only episode
>2500 parasites/μl 402 32 245 0.13 407 66 239 0.28 53 (28–69) <0.001 55 (31–70) <0.001
>0 parasites/μl 402 33 245 0.13 407 70 237 0.30 55 (31–70) <0.001 57 (34–71) <0.001
All multiple episodes
>2500 parasites/μl 402 38 254 0.15 407 86 255 0.34 56 (31–72) <0.001 58 (34–73) <0.001
>0 parasites/μl 402 40 254 0.16 407 94 255 0.37 58 (35–73) <0.001 60 (37–74) <0.001
Intention-to-treat analysis
First or only episode
>2500 parasites/μl 447 42 351 0.12 447 78 339 0.23 49 (26–65) <0.001
>0 parasites/μl 447 47 349 0.13 447 81 337 0.24 45 (21–62) 0.001
All multiple episodes
>2500 parasites/μl 447 49 364 0.13 447 107 365 0.29 54 (31–69) <0.001
>0 parasites/μl 447 57 364 0.16 447 117 365 0.32 50 (26–67) <0.001
*

Percentage efficacy was calculated by means of a Cox regression model for the risk of first episodes and a Poisson regression model for multiple episodes. The event rate was calculated by dividing the number of episodes by the person-years at risk. The according-to-protocol analysis was adjusted for the covariates use or nonuse of insecticide-treated net, age, distance from the dispensary, and village; data collection for this analysis began 2 weeks after the last vaccination and ended with the final blood test. The intention-to-treat analysis was unadjusted, and data collection began with the first vaccination and ended with the final blood test.