Table 4. HAI responses to vaccination in terms of seroprotection, seroconversion, and fold-increase in GMT above prevaccination levels for part B.
| Day | Responses | MAP-FA-15 | MAP-FA-10 | MAP-FA-5 | MAP-FA-2.5 | MAP-FA-0 | MAP-UA-15 | IM-QIV-15 |
|---|---|---|---|---|---|---|---|---|
| Day 1 | GMT (95% CI) | 20.7 (11.7–36.7) | 19.3 (11.0–33.9) | 23.0 (12.5–42.3) | 16.2 (9.8–26.9) | 13.2 (6.7–26.0) | 13.2 (7.7–22.7) | 12.3 (7.2–21.1) |
| Seroprotection; N (%) | 10/20 (50) | 9/20 (45) | 8/20 (40) | 8/20 (40) | 6/20 (30) | 6/20 (30) | 7/20 (35) | |
| p = 0.52 | p = 0.75 | p = 1.00 | p = 1.00 | p = 1.00 | ||||
| Day 4 | GMT (95% CI) | 20.7 (11.4–37.7) | 18.7 (10.8–32.2) | 23.1 (12.3–43.7) | 17.4 (10.2–29.7) | 13.2 (6.7–26.0) | 14.1 (8.0–25.0) | 12.7 (7.3–22.3) |
| p = 0.22 | p = 0.31 | p = 0.15 | p = 0.40 | p = 0.79 | ||||
| Seroprotection; N (%) | 10/20 (50) | 9/20 (45) | 7/19 (37) | 8/20 (40) | 6/20 (30) | 7/20 (35) | 7/20 (35) | |
| p = 0.52 | p = 0.75 | p = 1.00 | p = 1.00 | p = 1.00 | ||||
| Seroconversion; N (%) | 0/20 (0) | 0/20 (0) | 0/19 (0) | 0/20 (0) | 0/20 (0) | 0/20 (0) | 0/20 (0) | |
| N/A | N/A | N/A | N/A | N/A | ||||
| GMT fold-increase (95% CI) | 1.0 (0.9–1.1) | 1.0 (0.91.0) | 1.0 (1.0–1.1) | 1.1 (1.0–1.2) | 1.0 (1.0–1.0) | 1.1 (1.0–1.2) | 1.0 (1.0–1.1) | |
| p = 0.57 | p = 0.17 | p = 0.97 | p = 0.56 | p = 0.56 | ||||
| Day 8 | GMT (95% CI) | 218.6 (111.9–427.0) | 437.1 (254.3751.3) | 125.5 (61.4–256.9) | 72.1 (40.4–128.7) | 13.7 (6.8–27.6) | 242.5 (133.2–441.5) | 82.8 (42.4–161.8) |
| p = 0.04* | p < 0.001** | p = 38 | p = 0.74 | p = 0.02 * | ||||
| Seroprotection; N (%) | 19/20 (95) | 20/20 (100) | 17/20 (85) | 18/20 (90) | 6/20 (30) | 18/20 (90) | 17/20 (85) | |
| p = 0.60 | p = 0.23 | p = 1.00 | p = 1.00 | p = 1.00 | ||||
| Seroconversion; N (%) | 17/20 (85) | 18/20 (90) | 12/20 (60) | 11/20 (55) | 0/20 (0) | 18/20 (90) | 15/20 (75) | |
| p = 0.69 | p = 0.41 | p = 0.50 | p = 0.32 | p = 0.41 | ||||
| GMT fold-increase (95% CI) | 10.6 (4.8–23.3) | 22.6 (10.9–47.1) | 5.5 (3.0, 10.0) | 4.4 (2.8–7.0) | 1.0 (1.0–1.1) | 18.4 (10.3–32.9) | 6.7 (4.1–11.1) | |
| p = 0.32 | p = 0.007** | p = 0.59 | p = 0.21 | p = 0.001** | ||||
| Day 22 | GMT (95% CI) | 320.0 (160.5–638.1) | 485.0 (301.5–780.2) | 234.3 (121.9–450.0) | 144.2 (77.9–267.0) | 13.2 (6.7–26.0) | 367.6 (197.9–682.7) | 139.3 (79.3–244.5) |
| p = 0.58 | p = 0.001** | p = 0.21 | p = 0.93 | p = 0.02* | ||||
| Seroprotection; N (%) | 19/20 (95) | 20/20 (100) | 18/20 (90) | 18/20 (90) | 6/20 (30) | 19/20 (95) | 17/20 (85) | |
| p = 0.60 | p = 0.23 | p = 1.00 | p = 1.00 | p = 0.60 | ||||
| Seroconversion; N (%) | 17/20 (85) | 18/20 (90) | 14/20 (70) | 16/20 (80) | 0/20 (0) | 18/20 (90) | 15/20 (75) | |
| p = 0.69 | p = 0.41 | p = 1.00 | p = 1.00 | p = 0.41 | ||||
| GMT fold-increase (95% CI) | 15.5 (6.7–35.7) | 25.1 (13.4–46.9) | 10.2 (5.1–20.4) | 8.9 (5.0–15.8) | 1.0 (1.0–1.0) | 27.9 (15.0–51.7) | 11.3 (6.8–18.8) | |
| p = 0.51 | p = 0.05* | p = 0.80 | p = 0.51 | p = 0.02* | ||||
| Day 61 | GMT (95% CI) | 211.1 (121.7–366.3) | 309.1 (199.1–479.9) | 211.1 (121.7–366.3) | 125.5 (71.0–221.9) | 12.7 (6.4–25.5) | 278.6 (152.7–508.1) | 109.3 (59.4–200.9) |
| p = 0.10 | p = 0.001** | p = 0.10 | p = 0.73 | p = 0.03* | ||||
| Seroprotection; N (%) | 19/20 (95) | 20/20 (100) | 19/20 (95) | 18/20 (90) | 6/20 (30) | 19/20 (95) | 17/20 (85) | |
| p = 0.60 | p = 0.23 | p = 0.60 | p = 1.00 | p = 0.60 | ||||
| Seroconversion; N (%) | 16/20 (80) | 18/20 (90) | 14/20 (70) | 15/20 (75) | 0/20 (0) | 18/20 (90) | 13/20 (65) | |
| p = 0.48 | p = 0.13 | p = 1.00 | p = 0.73 | p = 0.13 | ||||
| GMT fold-increase (95% CI) | 10.2 (5.1–20.5) | 16.0 (9.6–26.8) | 9.2 (4.9–17.4) | 7.7 (4.4–13.6) | 1.0 (0.9–1.0) | 21.1 (12.0–37.0) | 8.9 (5.1–15.4) | |
| p = 0.75 | p = 0.11 | p = 0.93 | p = 0.71 | p = 0.03* |
Text in bold indicates that the previous Committee for Medicinal Products for Human Use (CHMP) threshold for the criterion has been met.
*p < 0.05
**p < 0.01 compared to the IM-QIV-15 group by Student t test (fold increase and GMTs) and using a Pearson's chi-square test with continuity correction for proportion of participants seroconverted or seroprotected.
N/A (not applicable) indicates no participants seroconverted in this group at this time point.
Abbreviations: FA, forearm; GMT, geometric mean titre; HAI, HA inhibition; IM, intramuscular; MAP, microarray patch; QIV, quadrivalent influenza vaccine; UA, upper arm