Table 3 Comparison of immunogenicity results after intradermal or intramuscular vaccination
Vaccine received in Year 1 | 3 μg ID | 6 μg ID | 15 μg IM | 3 μg ID | 6 μg ID | 15 μg IM | 3 μg ID | 6 μg ID | 15 μg IM | |
|---|---|---|---|---|---|---|---|---|---|---|
European Medicines Evaluation Agency criteria | A/H1N1 | A/H3N2 | B | |||||||
Geometric mean titre (95% CI) | - | 93.6 (78.5;112) | 110 (90.5;133) | 206 (177;239) | 132 (117;149) | 156 (137;178) | 300 (266;337) | 19.2 (17.1;21.5) | 21.7 (19.3;24.5) | 40.8 (36.1;46.2) |
Seroprotection rate*, % (95% CI) | >70 | 72.7 (67.9;77.1) | 71.3 (66.5;75.8) | 87.1 (83.3;90.3) | 88.5 (84.9;91.5) | 88.2 (84.5;91.3) | 96.9 (94.6;98.4) | 28.5 (23.9;33.3) | 32.9 (28.1;37.9) | 55.7 (50.5;60.8) |
Seroconversion†/significant increase rate‡, % (95% CI) | >40 | 53.1 (48.0;58.2) | 55.1 (50.0;60.1) | 75.0 (70.3;79.3) | 35.4 (30.6;40.4) | 43.0 (38.0;48.2) | 63.8 (58.7;68.6) | 21.0 (17.0;25.5) | 27.3 (22.8;32.1) | 47.7 (42.6;52.9) |
Geometric mean titre ratio (post-/pre-vaccination) (95% CI) | 2.5 | 7.32 (6.16;8.7) | 8.38 (6.94;10.1) | 17.4 (14.7;20.5) | 3.48 (3.02;4.01) | 4.19 (3.58;4.90) | 9.11 (7.71;10.8) | 2.38 (2.13;2.67) | 2.73 (2.42;3.07) | 4.97 (4.37;5.67) |
Vaccine received in Year 2 | 9 μg ID | 15 μg IM | 9 μg ID | 15 μg IM | 9 μg ID | 15 μg IM | ||||
Geometric mean titre (95% CI) | - | 180 (161; 202) | 192 (174; 212) | 380 (343; 420) | 386 (355; 420) | 80.6 (71.6; 90.7) | 83.1 (74.8; 92.3) | |||
Seroprotection rate*, % (95% CI) | >70 | 90.0 (87.1; 92.4) | 93.4 (90.0; 95.3) | 97.2 (95.4; 98.4) | 99.4 (98.4; 99.9) | 73.0 (69.1; 76.8) | 74.4 (70.5; 78.0) | |||
Seroconversion†/significant increase rate‡, % (95% CI) | >40 | 43.0 (38.8; 47.3) | 45.7 (41.4; 50.0) | 53.1 (48.8; 57.4) | 50.8 (46.5; 55.1) | 63.4 (59.2; 67.5) | 66.6 (62.5; 70.6) | |||
Geometric mean titre ratio (post-/pre-vaccination) (95% CI) | 2.5 | 4.3 (3.8; 4.8) | 4.7 (4.2; 5.3) | 4.4 (4.0; 5.0) | 4.4 (3.9; 5.0) | 7.8 (7.0; 8.8) | 8.3 (7.5; 9.1) | |||
Vaccine received in Year 3 | 9 μgID | 15 μgIM | 9 μgID | 15 μgIM | 9 μgID | 15 μgIM | ||||
Geometric mean titre (95% CI) | - | 127 (103; 158) | 117.8 (92.7; 149.6) | 415 (337; 510) | 300 (242; 373) | 91.0 (74.5; 111.1) | 86.2 (68.4; 108.7) | |||
Seroprotection rate*, % (95% CI) | >70 | 90.7 (83.6; 95.5) | 91.3 (84.2; 96.0) | 100 (96.6; 100) | 99.0 (94.8; 100.0) | 83.3 (74.9; 89.8) | 81.4 (72.4; 88.4) | |||
Seroconversion†/significant increase rate‡, % (95% CI) | >40 | 14.8 (8.7; 22.9) | 18.3 (11.4; 27.1) | 60.2 (50.3; 69.5) | 45.2 (35.4; 55.3) | 24.1 (16.4; 33.3) | 19.6 (12.4; 28.6) | |||
Geometric mean titre ratio (post-/pre-vaccination) (95% CI) | 2.5 | 2.0 (1.7; 2.4) | 2.1 (1.7; 2.5) | 4.6 (3.8; 5.6) | 3.5 (2.8; 4.4) | 2.3 (1.9; 2.7) | 2.3 (1.9; 2.8) | |||