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Table.2 The seroconversion rate and GMT of SARS-CoV-2 neutralizing antibody in the three groups

From: Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

SARS-CoV-2 neutralizing antibody Per-protocol analysis Intention-to-treat analysis
0–14 group
(n = 256)
0–21 group
(n = 247)
0–28 group
(n = 241)
0–14 group
(n = 270)
0–21 group
(n = 270)
0–28 group
(n = 269)
Primary analysis      
 GMT (95% CI) 98.4
(88.4–108.4)a
134.4
(123.1–145.7)b
145.5
(131.3–159.6)b
93.5
(83.7–103.3)a
122.0
(110.7–133.2)b
129.8
(116.2–143.4)b
Seroconversion (GMT ≥ 16)     
 No, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 14 (5.2) 23 (8.5) 28 (10.4)
 Yes, n (%) 256 (100.0) 247 (100.0) 241 (100.0) 256 (94.8)a 247 (91.5)ab 241 (89.6)b
 Crude OR (95% CI) 1.0 0.6 (0.3–1.2) 0.5(0.2–0.9)
 Adjusted OR (95% CI) 1.0 0.6 (0.3–1.2) 0.5(0.3–1.0)
Secondary analysis      
 GMT ≥ 32      
  No, n (%) 34 (13.3) 9 (3.6) 10 (4.1) 48 (17.8) 32 (11.8) 38 (14.1)
  Yes, n (%) 222 (86.7)a 238 (96.4)b 231 (95.9)b 222 (82.2) 238 (88.2) 231 (85.9)
  Crude OR (95% CI) 1.0 4.1 (1.9–8.6) 3.5 (1.7–7.3) 1.0 1.6 (1.0–2.6) 1.3 (0.8–2.1)
  Adjusted OR (95% CI) 1.0 4.1 (1.9–8.8) 3.6 (1.7–7.6) 1.0 1.7 (1.0–2.7) 1.4 (0.8–2.2)
 GMT ≥ 64      
  No, n (%) 100 (39.1) 38 (15.4) 46 (19.1) 114 (42.2) 61 (22.6) 74 (27.5)
  Yes, n (%) 156 (60.9)a 209 (84.6)b 195 (80.9)b 156 (57.8)a 209 (77.4)b 195 (72.5)b
  Crude OR (95% CI) 1.0 3.5(2.3–5.4) 2.7(1.8–4.1) 1.0 2.5(1.7–3.6) 1.9 (1.3–2.8)
  Adjusted OR (95% CI) 1.0 3.5 (2.7–5.8) 2.7 (1.8–4.1) 1.0 2.5 (1.7–3.7) 1.9 (1.4–2.8)
 GMT ≥ 128      
  No, n (%) 175 (68.4) 109 (44.1) 117 (48.5) 189 (70.0) 132 (48.9) 145 (53.9)
  Yes, n (%) 81 (31.6)a 138 (55.9)b 124 (51.5)b 81 (30.0)a 138 (51.1)b 124 (46.1)b
  Crude OR (95% CI) 1.0 2.7 (1.9–3.9) 2.3 (1.6–3.3) 1.0 2.44 (1.7–3.5) 2.0 (1.4–2.8)
  Adjusted OR (95% CI) 1.0 2.7 (1.9–3.9) 2.3 (1.6–3.4) 1.0 2.43 (1.7–3.5) 2.1 (1.4–3.0)
 GMT ≥ 256      
  No, n (%) 233 (91.0) 210 (85.0) 199 (82.6) 247 (91.5) 233 (86.3) 227 (84.4)
  Yes, n (%) 23 (9.0)a 37 (15.0)b 42 (17.4)b 23 (8.5)a 37 (13.7) ab 42 (15.6)b
  Crude OR (95% CI) 1.0 1.8 (1.0–3.1) 2.1 (1.2–3.7) 1.0 1.7 (1.0–3.0) 2.0 (1.2–3.4)
  Adjusted OR (95% CI) 1.0 1.8 (1.0–3.2) 2.3 (1.3–4.0) 1.0 1.8 (1.0–3.1) 2.1 (1.2–3.6)
  1. – No result value
  2. GMT Geometric mean titer; CI Confidence interval; OR Odds ratio
  3. a,bThere was significant difference with the different letters