Table 4. Vaccine efficacy evaluated for different follow-up periods.
Engerix B (n = 92) | RTS,S/AS02D (n = 93) | Vaccine Efficacy | |||||||
Events | PYAR | Rate | Events | PYAR | Rate | 95% CI | p | ||
ATP(3–9) | |||||||||
First or only (FO) episode of fever and parasitemia >500/µl | 34 | 31.5 | 1.08 | 21 | 38.2 | 0.55 | 48.8% | 11.3–70.4 | 0.017 |
FO episode of fever or history of fever* and parasitemia >0/µl | 48 | 27.7 | 1.74 | 29 | 36.4 | 0.80 | 54.5% | 27.3–71.5 | 0.001 |
Multiple episodes of fever and parasitemia>500/µl | 45 | 36.2 | 1.24 | 23 | 40.2 | 0.57 | 53.7% | 21.4–72.7 | 0.004 |
Multiple episodes of fever or history of fever* and parasitemia >0/µl | 72 | 36.0 | 2.00 | 34 | 40.0 | 0.85 | 58.9% | 35.8–73.6 | <0.001 |
ATP(3–14) | |||||||||
First or only (FO) episode of fever and parasitemia >500/µl | 45 | 51.3 | 0.88 | 36 | 61.7 | 0.58 | 33.0% | −4.3–56.9 | 0.076 |
FO episode of fever or history of fever* and parasitemia >0/µl | 57 | 41.4 | 1.38 | 45 | 57.1 | 0.79 | 41.9% | 13.7–60.9 | 0.007 |
Multiple episodes of fever and parasitemia>500/µl | 74 | 68.9 | 1.07 | 58 | 72.5 | 0.80 | 25.9% | −15.7–52.6 | 0.187 |
Multiple episodes of fever or history of fever* and parasitemia >0/µl | 120 | 68.4 | 1.75 | 85 | 72.3 | 1.18 | 35.1% | 2.2–57.0 | 0.039 |
ITT** (0–14) | |||||||||
First or only (FO) episode of fever and parasitemia >500/µl | 54 | 79.4 | 0.68 | 46 | 90.2 | 0.51 | 25.9% | −9.9–50.0 | 0.136 |
Multiple episodes of fever and parasitemia>500/µl | 105 | 111 | 0.94 | 82 | 113 | 0.72 | 24.3% | −12.9–49.2 | 0.173 |
Multiple episodes of fever and parasitemia>500/µl (PCD only) | 95 | 112 | 0.85 | 80 | 113 | 0.71 | 17.6% | −24.2–45.3 | 0.355 |
*History of fever in previous 24 hours.
**ITT: n = 107 for each group.
PYAR = Persons-years at risk. Vaccine efficacy adjusted estimates for area and distance from health center (km).
ATP = According to the Protocol; ITT = Intention to Treat; PCD = Passive Case Detection.