Skip to main content

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.
\