Table 3 |
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|
Summary of immunogenicity data in the immunogenicity set. |
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|
Season 1 2005-2006 |
Season 2 2006-2007 |
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|
|
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|
Vaccine N = 891 |
Placebo N = 136 |
Vaccine N = 407 |
Placebo N = 80 |
|
|
|
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|
A/New Caledonia (H1N1) |
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|
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) |
|
|
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|
A/New York (H3N2) |
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|
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 |
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|
Jackson et al. BMC Infectious Diseases 2010 10:71 doi:10.1186/1471-2334-10-71 |
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