Table 3.
Summary of immunogenicity data in the immunogenicity set.
| Season 1 2005-2006 |
Season 2 2006-2007 |
|||
|---|---|---|---|---|
| Vaccine N = 891 |
Placebo N = 136 |
Vaccine N = 407 |
Placebo N = 80 |
|
| A/New Caledonia (H1N1) | ||||
| Day 0 GMT (95% CI)† | 35.2 (32.0, 38.6) | 31.5 (24.7, 40.1) | 35.5 (30.8, 40.9) | 34.1 (24.8, 47.0) |
| Day 21 GMT (95% CI)† | 385.4 (353.0, 420.8) | 30.9 (24.7, 38.7) | 352.5 (309.7, 401.3) | 38.1 (28.4, 51.0) |
| GMFR (95% CI)‡ | 10.96 (9.87, 12.18) | 0.98 (0.75, 1.28) | 9.94 (8.55, 11.55) | 1.11 (0.79, 1.56) |
| Seroconversion, n (%; 95% CI) | 605 (68%; 65.0, 71.0) | 0 (0%, 00.0, 00.0) | 275 (68%; 63.0, 72.0) | 1 (1%; 00.0, 4.0) |
| Day 0 HI titers ≥ 1:40, n (%; 95% CI)¶ | 454 (51%; 48.0, 54.0) | 70 (51%; 43.0, 60.0) | 200 (49%; 44.0, 54.0) | 40 (50%; 39.0, 61.0) |
| Day 21 HI titers ≥ 1:40, n (%; 95% CI)¶ | 863 (97%; 96.0, 98.0) | 71 (52%; 44.0, 61.0) | 399 (98%; 97.0, 99.0) | 41 (51%; 40.0, 62.0) |
| A/New York (H3N2) | ||||
| Day 0 GMT (95% CI) | 16.3 (15.2, 17.5) | 16.2 (13.4, 19.5) | - | - |
| Day 21 GMT (95% CI)† | 258.4 (237.0, 281.7) | 16.5 (13.2, 20.5) | - | - |
| GMFR (95% CI)‡ | 15.84 (14.56, 17.23) | 1.02 (0.82, 1.26) | - | - |
| Seroconversion, n (%; 95% CI)¶ | 756 (85%; 82.0, 87.0) | 1 (1) (1.%; 0.0, 2.0) | ||
| Day 0 HI titers ≥ 1:40, n (%; 95% CI) | 273 (31%; 28.0, 34.0) | 41 (30%; 22.0, 38.0) | - | - |
| Day 21 HI titers ≥ 1:40, n (%; 95% CI) | 837 (94%; 92.0, 96.0) | 42 (31%; 23.0, 39.0) | - | - |
| A/Wisconsin (H3N2) | ||||
| Day 0 GMT (95% CI) | - | - | 14.9 (13.3, 16.7) | 14.2 (11.0, 18.4) |
| Day 21 GMT (95% CI)† | - | - | 157.6 (140.3, 177.1) | 14.7 (11.3, 19.1) |
| GMFR (95% CI)‡ | - | - | 10.59 (9.26, 12.11) | 1.04 (0.77, 1.40) |
| Seroconversion, n (%; 95% CI)¶ | - | - | 292 (72%; 67.0, 76.0) | 1 (1%; 0.0, 4.0) |
| Day 0 HI titers ≥ 1:40, n (95% CI) | - | - | 116 (29%; 24.0, 33.0) | 23 (29%; 19.0, 0.39) |
| Day 21 HI titers ≥ 1:40 (95% CI) | - | - | 375 (92%; 90.0, 95.0) | 23 (29%; 19.0, 39.0) |
| B/Jiangsu (Yamagata) | ||||
| Day 0 GMT (95% CI)† | 25.4 (23.4, 27.4) | 23.9 (19.6, 29.3) | ||
| Day 21 GMT (95% CI)† | 313.5 (290.1, 338.7) | 24.5 (20.1, 29.9) | ||
| GMFR (95% CI)‡ | 12.36 (11.35, 13.46) | 1.02 (0.82, 1.27) | - | - |
| Seroconversion, n (%; 95% CI)¶ | 727 (82%; 79.0, 84.0) | 1 (1%; 0.0, 2.0) | ||
| Day 0 HI titers ≥ 1:40, n (%; 95% CI) | 416 (47%; 43.0, 50.0) | 63 (46%; 38.0, 55.0) | ||
| Day 21 HI titers ≥ 1:40, n (%; 95% CI) | 873 (98%; 97.0, 99.0) | 65 (48%; 39.0, 56.0) | ||
| B/Malaysia (Victoria) | ||||
| Day 0 GMT (95% CI)† | 23.9 (19.6, 29.3) | 35.7 (27.2, 46.8) | ||
| Day 21 GMT (95% CI)† | 294.5 (263.9, 328.7) | 38.4 (30.0, 49.2) | ||
| Seroconversion, n (%; 95% CI)¶ | - | - | 301 (74%; 70.0, 78.0) | 1 (1%; 0.0, 4.0) |
| GMFR (95% CI)‡ | - | - | 11.45 (9.98, 13.13) | 1.08 (0.79, 1.47) |
| Day 0 HI titers ≥ 1:40, n (%; 95% CI)¶ | - | - | 179 (44%; 39.0, 49.0) | 45 (56%; 45.0, 97.0) |
| Day 21 HI titers ≥ 1:40, n (%; 95% CI)¶ | - | - | 396 (97%; 96.0, 99.0) | 48 (60%; 49.0, 71.0) |
GMT, geometric mean titer; GMFR geometric mean fold ratio; HI, hemagglutination-inhibiting; CI, Confidence Interval
† 95% CI based on log (base 10) transformed reciprocal titers, error term from ANOVA
‡ Two-sided, 95% CI on the geometric mean fold-increase in reciprocal HAI antibody titer based on the log (base 10) transformed data
¶ Two-sided, 95% CI on the point estimates for binomial proportions