TABLE 3.
Entry | 24 mo (Before PPV-23) | 26 mo (After PPV-23) | Exit | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
HU (n = 73) | Placebo (n = 69) | Pa | HU (n = 65) | Placebo (n = 58) | Pa | HU (n = 63) | Placebo (n = 56) | Pa | HU (n = 66) | Placebo (n = 62) | Pa | |
Serotype 26 (6B) | ||||||||||||
Geometric mean antibody (μg/mL) | 7.4 | 7.2 | 6.9 | 5.4 | 37.9 | 46.6 | 9.4 | 9.6 | ||||
95% CI | [5.7–9.5] | [5.7–9.2] | [5.1–9.3] | [4.2–7.0] | [29.6–48.6] | [35.3–61.4] | [7.6–11.7] | [7.6–12.0] | ||||
% Protective (≥1.0 μg/mL) | 97.3 | 97.1 | >.999 | 92.3 | 94.8 | .721 | 100 | 100 | — | 100 | 100 | — |
95% CI | [90.5–99.7] | [89.9–99.7] | [83.0–97.5] | [85.6–98.9] | [94.3–100.0] | [93.6–100.0] | [94.6–100.0] | [94.2–100.0] | ||||
% Protective (≥0.35 μg/mL) | 100.0 | 100.0 | — | 100.0 | 98.3 | .471 | 100 | 100 | — | 100 | 100 | — |
95% CI | [95.1–100.0] | [94.8–100.0] | [94.5–100.0] | [90.8–100.0] | [94.3–100.0] | [93.6–100.0] | [94.6–100.0] | [94.2–100.0] | ||||
Serotype 51 (7F) | ||||||||||||
Geometric mean antibody (μg/mL) | 1.2 | 1.0 | 1.5 | 1.2 | 8.4 | 9.4 | 3.7 | 3.2 | ||||
95% CI | [1.0–1.5] | [ 0.8–1.2] | [1.2–1.9] | [0.9–1.5] | [6.4–11.0] | [7.2–12.2] | [3.0–4.5] | [2.6–3.9] | ||||
% Protective (≥1.0 μg/mL) | 60.3 | 47.8 | .177 | 72.3 | 58.6 | .129 | 100 | 98.2 | .47 | 90.9 | 93.5 | .745 |
95% CI | [48.1–71.6] | [35.7–60.2] | [59.8–82.7] | [44.9–71.4] | [94.3–100.0] | [90.5–100.0] | [81.3–96.6] | [84.3–98.2] | ||||
% Protective (≥0.35 μg/mL) | 91.8 | 85.5 | .292 | 93.8 | 94.8 | >.999 | 100 | 100 | — | 100 | 100 | — |
95% CI | [83.0–96.9] | [75.0–92.8] | [85.0–98.3] | [85.6–98.9] | [94.3–100.0] | [93.6–100.0] | [94.6–100.0] | [94.2–100.0] |
CI, confidence interval; HU, hydroxyurea.
No P value calculated (—) when hydroxyurea and placebo % protected = 100%.
Fisher’s exact test.