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Table 3 Haemagglutination inhibition antibodies against vaccine homologous A/California/7/2009 strain [CHMP/CBER criteria] (According To Protocol cohort for immunogenicity)

From: A randomized, controlled non-inferiority trial comparing A(H1N1)pmd09 vaccine antigen, with and without AS03 adjuvant system, co-administered or sequentially administered with an inactivated trivalent seasonal influenza vaccine

Immune response Time point Group A Group B Group C Group D Group E Group F
   Day 0: TIVa+Placebo Day 0: TIV +Placebo Day 0: 15 μg +TIV Day 0: 3.75 μg/ AS03+TIV Day 0: 15 μg +Placebo Day 0: .75 μg/ AS03+Placebo
   Day 21: 15 μg Day 21: 3.75 μg/AS03 Day 21: 15 μg Day 21: 3.75 μg/AS03 Day 21: 15 μg Day 21: 3.75 μg/AS03
   Day 42: 15 μg Day 42: 3.75 μg/AS03 Day 42: Placebo Day 42: Placebo Day 42: TIV Day 42: TIV
   Value or % [95% CIb]
  Day 21 Na=92 N=86 N=92 N=88 N=91 N=91
Day 42 N=92 N=86 N=92 N=88 N=91 N=91
Day 63 N=92 N=86 N=92 N=88 N=91 N=91
Day 182 N=92 N=89 N=85 N=88 N=89 N=91
Seroconversion rate Day 21 20.7% 23.3% 87.0% 95.5% 93.4% 97.8%
[CBERc: LLe of 95% CI >40%]
[12.9-30.4%] [14.8-33.6%] [78.3-93.1%] [88.8-98.7%] [86.2-97.5%] [92.3-99.7%]
[CHMPd: point estimate >40%] Day 42 85.9% 96.5% 91.3% 96.6% 96.7% 98.9%
[77.0-92.3%] [90.1-99.3%] [83.6-96.2%] [90.4-99.3%] [90.7-99.3%] [94.0-100%]
Day 63 85.9% 97.7% 91.3% 95.5% 94.5% 98.9%
[77.0-92.3%] [91.9-99.7%] [83.6-96.2%] [88.8-98.7%] [87.6-98.2%] [94.0-100%]
Day 182 76.1% 87.6% 78.8% 89.8% 87.6% 92.3%
[66.1-84.4%] [79.0-93.7%] [68.6-86.9%] [81.5-95.2%] [79.0-93.7%] [84.8-96.9%]
Seroprotection rate Day 0 25.0% 10.5% 19.6% 18.2% 13.2% 13.2%
[CBER: LL of 95% CI >70%]
[16.6-35.1%] [4.9-18.9%] [12.0-29.1%] [10.8-27.8%] [7.0-21.9%] [7.0-21.9%]
[CHMP: point estimate >70%] Day 21 48.9% 39.5% 96.7% 98.9% 97.8% 100%
[38.3-59.6%] [29.2-50.7%] [90.8-99.3%] [93.9-100%] [92.3 -99.7%] [96.0-100%]
Day 42 97.8% 100% 100% 100% 100% 100%
[92.4-99.7%] [95.8-100%] [96.1-100%] [95.9-100%] [96.0-100%] [96.0-100%]
Day 63 97.8% 100% 100% 100% 98.9% 100%
[92.4-99.7%] [95.8-100%] [96.1-100%] [95.9-100%] [94.0-100%] [96.0-100%]
Day 182 90.2% 97.8% 92.9% 100% 94.4% 97.8%
[82.2-95.4%] [92.1-99.7%] [85.3-97.4%] [95.9-100%] [87.4-98.2%] [92.3-99.7%]
Geometric mean fold rise Day 21 2.1 2.4 21.3 33.7 38.4 65.3
[1.8-2.6] [1.9-3.0] [16.4-27.7] [26.0-43.6] [29.3-50.5] [51.1-83.5]
[CHMP: point estimate >2.5]
  Day 42 16.3 36.5 20.9 54.9 41.5 92.4
[12.6-21.1] [28.9-46.0] [16.3-26.7] [42.1-71.7] [32.4-53.2] [73.3-116.3]
Day 63 17.4 59.4 18.8 39.8 37.0 69.7
[13.4-22.6] [46.6-75.7] [14.7-24.1] [31.2-50.7] [28.6-47.9] [55.1-88.1]
Day 182 9.5 17.7 11.1 15.1 21.9 32.5
[7.3-12.4] [14.3-21.8] [8.6-14.4] [11.9-19.1] [16.4-29.4] [26.0-40.7]
Geometric mean titres Day 0 14.6 10.9 13.0 10.7 9.3 10.1
[11.2-19.0] [8.7-13.6] [10.2-16.5] [8.2-14.0] [7.7-11.4] [8.2-12.5]
Day 21 31.1 26.3 277.3 361.0 358.7 659.8
[24.0-40.3] [19.9-34.8] [222.4-345.7] [301.5-432.2] [285.0 -451.4] [546.0-797.4]
Day 42 238.6 396.2 271.2 589.8 387.1 933.1
[191.8-296.7] [329.2-476.8] [224.6-327.4] [517.8-671.8] [314.4-476.7] [815.6-1067.6]
Day 63 254.2 645.2 245.0 426.9 345.3 704.0
[210.1-307.7] [557.6-746.6] [200.7-299.1] [373.0-488.5] [278.6-428.0] [602.1-823.1]
Day 182 136.6 206.9 151.7 171.7 218.5 323.6
   [108.6-171.9] [171.3-249.9] [119.1-193.2] [143.2-205.8] [169.8-281.1] [268.8-389.5]
  1. a N = Number of subjects with available results.
  2. b CI = Confidence Interval.
  3. c CBER = Center for Biologics Evaluation & Research.
  4. d CHMP: Committee for Medicinal Products for Human Use.
  5. e LL = Lower limit.
  6. BOLD : values of SPR and Geometric mean fold rise that did not meet the pre-specified criteria.