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Table 5 Descriptive immunogenicity based on HI antibody titers in the per-protocol cohort for immunogenicity

From: Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

Parameter

Vaccine

Day

N

A/California/7/2009 (H1N1)

A/Victoria/210/2009 (H3N2)

B/Brisbane/60/2008 (Victoria)

B/Brisbane/3/2007 (Yamagata)

GMTs, value (95% CI)

QIV

Day 0

1801

14.7

34.0

73.8

101.4

(13.8, 15.6)

(31.8, 36.3)

(69.1, 78.8)

(94.5, 108.8)

 

Day 21

1809

201.1

314.7

404.6

601.8

(188.1, 215.1)

296.8, 333.6)

(386.6, 423.4)

(573.3, 631.6)

 

TIV-Vic

Day 0

605

15.6

38.1

73.6

100.9

(14.1, 17.3)

(34.1, 42.7)

(65.5, 82.8)

(89.3, 113.9)

  

Day 21

608

218.4

298.2

393.8

386.6

(194.2, 245.6)

(268.4, 331.3)

(362.7, 427.6)

(351.5, 425.3)

 

TIV-Yam

Day 0

530

14.4

35.7

71.7

99.8

(12.9, 16.0)

(31.6, 40.3)

(63.4, 81.0)

(87.7, 113.5)

  

Day 21

534

213.0

340.4

258.5

582.5

(187.6, 241.9)

(304.3, 380.9)

(234.6, 284.8)

(534.6, 634.7)

SPR, % (95% CI)

QIV

Day 0

1801

28.5%

53.6%

79.0%

83.0%

(26.5, 30.7)

(51.2, 55.9)

(77.1, 80.9)

(81.1, 84.7)

 

Day 21

1809

91.3%

96.8%

98.8%

99.1%

(89.9, 92.5)

(95.9, 97.6)

(98.2, 99.3)

(98.5, 99.5)

 

TIV-Vic

Day 0

605

27.6%

58.3%

78.8%

82.1%

(24.1, 31.4)

(54.3, 62.3)

(75.4, 82.0)

(78.9, 85.1)

  

Day 21

608

91.8%

95.9%

98.5%

97.9%

(89.3, 93.8)

(94.0, 97.3)

(97.2, 99.3)

(96.4, 98.9)

 

TIV-Yam

Day 0

530

26.2%

53.8%

77.7%

83.2%

(22.5, 30.2)

(49.4, 58.1)

(74.0, 81.2)

(79.7, 86.3)

  

Day 21

534

92.7%

96.8%

96.1%

99.6%

(90.2, 94.8)

(95.0, 98.1)

(94.1, 97.5)

(98.7, 100)

SCR, % (95%)

QIV

Day 21

1801

77.5%

71.5%

58.1%

61.7%

(75.5, 79.4)

(69.3, 73.5)

(55.8, 60.4)

(59.5, 64.0)

 

TIV-Vic

Day 21

605

77.2%

65.8%

55.4%

45.6%

(73.6, 80.5)

(61.9, 69.6)

(51.3, 59.4)

(41.6, 49.7)

 

TIV-Yam

Day 21

530

80.2%

70.0%

47.5%

59.1%

(76.5, 83.5)

(65.9, 73.9)

(43.2, 51.9)

(54.7, 63.3)

SCF, value (95%)

QIV

Day 21

1801

13.69

9.28

5.48

5.93

(12.70, 14.76)

(8.64, 9.96)

(5.12, 5.85)

(5.53, 6.36)

TIV-Vic

Day 21

605

13.92

7.84

5.37

3.84

(12.23, 15.84)

(6.93, 8.88)

(4.75, 6.06)

(3.42, 4.30)

 

TIV-Yam

Day 21

530

14.88

9.52

3.60

5.84

    

(12.91, 17.16)

(8.33, 10.89)

(3.25, 3.98)

(5.13, 6.65)

  1. CI confidence interval, HI hemagglutination-inhibition, GMT geometric mean titer, SPR seroprotection rate, SCR seroconversion rate, SCF seroconversion factor, QIV inactivated quadrivalent influenza vaccine, TIV-Vic inactivated trivalent influenza vaccine Victoria lineage B strain, TIV-Yam inactivated trivalent vaccine Yamagata lineage B strain.
  2. SPR defined as proportion of subjects with HI antibody titers ≥ 1:40; SCR defined as proportion of subjects with a pre-vaccination HI antibody titer < 1:10 and post-vaccination HI antibody titer ≥ 1:40, or subjects with at least a 4-fold increase in the post-vaccination HI antibody titer; SCF defined as the geometric mean of the within subject ratios of reciprocal HI antibody titers for post-vaccination versus pre-vaccination.