Table 2 Summary of seroprotection rates of antibody concentration (Per-Protocol Immunogenicity Population)
Antibody | Assessment | Criterion | Lot A | Lot B | Lot C | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Na | %SPb | 95 % CI | N | %SP | 95 % CI | N | %SP | 95 % CI | |||
Diphtheria | Pre-dose 1 | ≥0.01 IU/ml | 59 | 30.4 | 24.4–37.2 | 67 | 35.1 | 28.7–42.1 | 49 | 25.8 | 20.1–32.4 |
Pre-dose 1 | ≥0.1 IU/ml | 0 | 0.0 | NA | 7 | 3.7 | 1.8–7.4 | 3 | 1.6 | 0.5–4.5 | |
Post-dose 3 | ≥0.01 IU/ml | 193 | 99.5 | 97.1–99.9 | 190 | 99.5 | 97.1–99.9 | 190 | 100.0 | 98.0–100.0 | |
Post-dose 3 | ≥0.1 IU/ml | 168 | 86.6 | 81.1–90.7 | 153 | 80.1 | 73.9–85.1 | 162 | 85.3 | 79.5–89.6 | |
Tetanus | Pre-dose 1 | ≥0.01 IU/ml | 194 | 100.0 | 98.1–100.0 | 191 | 100.0 | 98.0–100.0 | 190 | 100.0 | 98.0–100.0 |
Pre-dose 1 | ≥0.1 IU/ml | 183 | 94.3 | 90.1–96.8 | 180 | 94.2 | 90.0–96.8 | 180 | 94.7 | 90.6–97.1 | |
Post-dose 3 | ≥0.01 IU/ml | 194 | 100.0 | 98.1–100.0 | 191 | 100.0 | 98.0–100.0 | 190 | 100.0 | 98.0–100.0 | |
Post-dose 3 | ≥0.1 IU/ml | 189 | 97.4 | 94.1–98.9 | 187 | 97.9 | 94.7–99.2 | 184 | 96.8 | 93.3–98.5 | |
Pertussis | Pre-dose 1 | ≥40 (1/dil) | 11 | 5.7 | 3.2–9.9 | 8 | 4.2 | 2.1–8.0 | 9 | 4.7 | 2.5–8.8 |
Pre-dose 1 | ≥80 (1/dil) | 3 | 1.5 | 0.5–4.4 | 3 | 1.6 | 0.5–4.5 | 2 | 1.1 | 0.3–3.8 | |
Post-dose 3 | ≥40 (1/dil) | 172 | 88.7 | 83.4–92.4 | 158 | 82.7 | 76.7–87.4 | 161 | 84.7 | 80.6–87.1 | |
Post-dose 3 | ≥80 (1/dil) | 157 | 80.9 | 74.8–85.8 | 140 | 73.3 | 66.6–79.1 | 143 | 75.3 | 68.6–81.1 | |
Post-dose 3 | VRRc | 173 | 89.2 | 83.9–92.9 | 156 | 81.7 | 77.6–84.1 | 159 | 83.7 | 77.7–88.4 | |
Hepatitis B | Pre-dose 1 | ≥10 mIU/ml | 28 | 14.4 | 10.2–20.1 | 33 | 17.3 | 12.6–23.3 | 30 | 15.8 | 11.3–21.6 |
Post-dose 3 | ≥10 mIU/ml | 191 | 98.5 | 95.6–99.5 | 190 | 99.5 | 97.1–99.9 | 190 | 100.0 | 98.0–100.0 | |
PRP (Hib) | Pre-dose 1 | ≥0.15 μg/ml | 57 | 29.4 | 23.4–36.1 | 45 | 23.6 | 18.1–30.1 | 57 | 30.0 | 23.9–36.9 |
Pre-dose 1 | ≥1.0 μg/ml | 22 | 11.3 | 7.6–16.6 | 10 | 5.2 | 2.9–9.4 | 19 | 10.0 | 6.5–15.1 | |
Post-dose 3 | ≥0.15 μg/ml | 194 | 100.0 | 98.0–100.0 | 191 | 100.0 | 98.0–100.0 | 190 | 100.0 | 98.0–100.0 | |
Post-dose 3 | ≥1.0 μg/ml | 188 | 96.5 | 93.4–98.6 | 183 | 95.8 | 92.0–97.9 | 181 | 95.3 | 91.2–97.5 | |