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

Jackson et al. BMC Infectious Diseases 2010 10:71   doi:10.1186/1471-2334-10-71

Open Data