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Table 3 Summary of immunogenicity data in the immunogenicity set.

From: Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons

  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)
  1. GMT, geometric mean titer; GMFR geometric mean fold ratio; HI, hemagglutination-inhibiting; CI, Confidence Interval
  2. 95% CI based on log (base 10) transformed reciprocal titers, error term from ANOVA
  3. Two-sided, 95% CI on the geometric mean fold-increase in reciprocal HAI antibody titer based on the log (base 10) transformed data
  4. Two-sided, 95% CI on the point estimates for binomial proportions