TABLE 1.
Summary of Vaccine Homologous HI Antibody Parameters at Days 0, 42, 385 and 392 (Adapted ATP Cohort for Immunogenicity)
| ≥10 1/DIL | SPR | GMT | SCR | MGI | ||||
|---|---|---|---|---|---|---|---|---|
| Formulation | N | n (%; 95% CI) | n (%; 95% CI) | Value (95% CI) | N′ | n′ (%; 95% CI) | Value (95% CI) | |
| 1.9 µg HA/AS03B | Day 0 | 36 | 1 (2.8; 0.1–14.5) | 0 (0.0; 0.0–9.7) | 5.1 (4.9–5.3) | - | - | - |
| Day 42 | 36 | 36 (100; 90.3–100) | 36 (100; 90.3–100) | 1118.6 (884.4–1414.9) | 36 | 36 (100; 90.3–100) | 219.5 (172.6–279.0) | |
| Day 385 | 34 | 34 (100; 89.7–100) | 33 (97.1; 84.7–99.9) | 98.1 (76.7–125.4) | 34 | 33 (97.1; 84.7–99.9) | 19.2 (14.8–24.9) | |
| Day 392 | 34 | 34 (100; 89.7–100) | 34 (100; 89.7–100) | 476.2 (348.4–650.9) | 34 | 34 (100; 89.7–100) | 93.3 (67.9–128.3) | |
| 0.9 µg HA/AS03C | Day 0 | 33 | 1 (3.0; 0.1–15.8) | 0 (0.0; 0.0–10.6) | 5.1 (4.9–5.3) | - | - | - |
| Day 42 | 33 | 33 (100; 89.4–100) | 33 (100; 89.4–100) | 858.8 (659.2–1118.8) | 33 | 33 (100; 89.4–100) | 168.2 (127.4–222.0) | |
| Day 385 | 33 | 33 (100; 89.4–100) | 26 (78.8; 61.1–91.0) | 61.5 (47.1–80.3) | 33 | 26 (78.8; 61.1–91.0) | 12.0 (9.2–15.8) | |
| Day 392 | 33 | 33 (100; 89.4–100) | 33 (100; 89.4–100) | 407.6 (315.0–527.4) | 33 | 33 (100; 89.4–100) | 79.8 (61.5–103.5) | |
| 1.9 µg HA/AS03C | Day 0 | 37 | 1 (2.7; 0.1–14.2) | 0 (0.0; 0.0–9.5) | 5.1 (4.9–5.4) | - | - | - |
| Day 42 | 37 | 37 (100; 90.5–100) | 37 (100; 90.5–100) | 913.6 (672.6–1241.1) | 37 | 37 (100; 90.5–100) | 177.7 (131.5–240.1) | |
| Day 385 | 37 | 37 (100; 90.5–100) | 28 (75.7; 58.8–88.2) | 72.1 (51.6–100.7) | 37 | 28 (75.7; 58.8–88.2) | 14.0 (10.0–19.7) | |
| Day 392 | 37 | 37 (100; 90.5–100) | 37 (100; 90.5–100) | 305.4 (227.1–410.6) | 37 | 37 (100; 90.5–100) | 59.4 (44.5–79.4) | |
| 3.75 µg HA/AS03C | Day 0 | 31 | 0 (0.0; 0.0–11.2) | 0 (0.0; 0.0–11.2) | 5.0 (5.0–5.0) | - | - | - |
| Day 42 | 31 | 31 (100; 88.8–100) | 31 (100; 88.8–100) | 640.0 (488.3–839.0) | 31 | 31 (100; 88.8–100) | 128.0 (97.7–167.8) | |
| Day 385 | 31 | 31 (100; 88.8–100) | 28 (90.3; 74.2–98.0) | 79.1 (59.2–105.6) | 31 | 28 (90.3; 74.2–98.0) | 15.8 (11.8–21.1) | |
| Day 392 | 31 | 31 (100; 88.8–100) | 31 (100; 88.8–100) | 286.2 (216.0–379.1) | 31 | 31 (100; 88.8–100) | 57.2 (43.2–75.8) | |
| 3.75 µg HA/AS03D | Day 0 | 35 | 3 (8.6; 1.8–23.1) | 0 (0.0; 0.0–10.0) | 5.6 (4.9–6.5) | - | - | - |
| Day 42 | 35 | 35 (100; 90.0–100) | 35 (100; 90.0–100) | 568.4 (442.7–729.8) | 35 | 35 (100; 90.0–100) | 101.0 (74.8–136.4) | |
| Day 385 | 32 | 32 (100; 89.1–100) | 23 (71.9; 53.3–86.3) | 59.6 (45.0–79.0) | 32 | 21 (65.6; 46.8–81.4) | 10.5 (7.6–14.5) | |
| Day 392 | 32 | 32 (100; 89.1–100) | 32 (100; 89.1–100) | 201.0 (156.1–258.7) | 32 | 32 (100; 89.1–100) | 35.3 (25.9–48.1) | |
AS03 indicates adjuvant system containing DL-α-tocopherol and squalene in oil-in-water emulsion (AS03B containing 5.93 mg DL-α-tocopherol, AS03C containing 2.97 mg DL-α-tocopherol, and AS03D containing 1.48 mg DL-α-tocopherol); DIL, dilution; N, number of subjects with results available for seropositivity rates, SPR and GMT; N', number of subjects with both pre and post results available for SCR and MGI; n, number of subjects meeting the SPR; n', number of seroconverted subjects.
MGI is defined as geometric mean of within-subject ratios of post-vaccination reciprocal HI titer to pre-vaccination reciprocal HI titer. SPR is defined as the percentage of subjects with HI titers ≥1:40 post-vaccination. SCR for initially seronegative subjects is defined as percentage of subjects with HI titers ≥1:40 post-vaccination and for initially seropositive subjects it is defined as percentage of subjects with ≥4-fold post-vaccination increase in HI titer from pre-vaccination antibody..