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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.
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BMC Infectious Diseases

ISSN: 1471-2334

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