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Table 1 Baseline characteristics in the safety and intention-to-treat population

From: Safety and efficacy of the FAKHRAVAC compared with BBIBP-Corv2 against SARS-CoV-2 in adults: a non-inferiority multi-center trial

Characteristic

Fakhravac

random

N = 824

BBIBP-Corv2

random

N = 832

Fakhravac

non-random

N = 19,429

BBIBP-Corv2

non-random

N = 2971

Fakhravac

overall

N = 20,253

BBIBP-Corv2

overall

N = 3803

Overall

N = 24,056

Sex n (%)

 Female

306 (37%)

310 (37%)

9216 (47%)

1267 (43%)

9522 (47%)

1577 (41%)

11,099 (46%)

 Male

518 (63%)

522 (63%)

10,210 (53%)

1702 (57%)

10,728 (53%)

2224 (59%)

12,952 (54%)

Age mean (SD)

30.9 (8.7)

31.3 (9)

34 (11.1)

34.1 (11.3)

35.9 (10.9)

35.5 (10.8)

33.8 (11)

 18–30 n (%)

297 (36%)

309 (37%)

5763 (30%)

932 (31%)

6060 (30%)

1241 (33%)

7301 (30%)

 30–40 n (%)

351 (43%)

334 (40%)

6982 (36%)

982 (33%)

7333 (36%)

1316 (35%)

8649 (36%)

 40–50 n (%)

152 (18%)

153 (18%)

4447 (23%)

703 (24%)

4599 (23%)

856 (23%)

5455 (23%)

 50–60 n (%)

23 (2.8%)

31 (3.7%)

1647 (8.5%)

244 (8.2%)

1670 (8.2%)

275 (7.2%)

1945 (8.1%)

 60+ n (%)

1 (0.1%)

5 (0.6%)

584 (3.0%)

108 (3.6%)

585 (2.9%)

113 (3.0%)

698 (2.9%)

BMI mean (SD)

26.1 (5)

25.8 (4.6)

25.7 (4.5)

25.1 (3.8)

25.7 (4.5)

25.3 (4)

25.7 (4.5)

Education n (%)

 Elementary

17 (2.1%)

18 (2.2%)

543 (2.8%)

147 (5.0%)

560 (2.8%)

165 (4.3%)

725 (3.0%)

 Below diploma

78 (9.5%)

70 (8.4%)

2487 (13%)

531 (18%)

2565 (13%)

601 (16%)

3166 (13%)

 Diploma

282 (34%)

290 (35%)

6708 (35%)

1070 (36%)

6990 (35%)

1360 (36%)

8350 (35%)

 Above diploma

74 (9.0%)

87 (10%)

1746 (9.0%)

224 (7.5%)

1820 (9.0%)

311 (8.2%)

2131 (8.9%)

 Bachelor

262 (32%)

267 (32%)

6003 (31%)

774 (26%)

6265 (31%)

1041 (27%)

7306 (30%)

 Master

91 (11%)

84 (10%)

1667 (8.6%)

172 (5.8%)

1758 (8.7%)

256 (6.7%)

2014 (8.4%)

 Doctoral and above

19 (2.3%)

16 (1.9%)

272 (1.4%)

51 (1.7%)

291 (1.4%)

67 (1.8%)

358 (1.5%)

Comorbidities n (%)

 High blood pressure

14 (1.7%)

21 (2.5%)

541 (2.8%)

72 (2.4%)

555 (2.7%)

93 (2.4%)

648 (2.7%)

 Chronic heart disease

5 (0.6%)

10 (1.2%)

135 (0.7%)

20 (0.7%)

140 (0.7%)

30 (0.8%)

170 (0.7%)

 Chronic non-asthma lung dis

1 (0.1%)

2 (0.2%)

102 (0.5%)

13 (0.4%)

103 (0.5%)

15 (0.4%)

118 (0.5%)

 Asthma

6 (0.7%)

6 (0.7%)

118 (0.6%)

14 (0.5%)

124 (0.6%)

20 (0.5%)

144 (0.6%)

 Chronic kidney disease

1 (0.1%)

2 (0.2%)

59 (0.3%)

14 (0.5%)

60 (0.3%)

16 (0.4%)

76 (0.3%)

 Moderate/severe liver dis

1 (0.1%)

0 (0%)

42 (0.2%)

5 (0.2%)

43 (0.2%)

5 (0.1%)

48 (0.2%)

 (Fatty liver) Mild liver disease

27 (3.3%)

36 (4.3%)

453 (2.3%)

30 (1.0%)

480 (2.4%)

66 (1.7%)

546 (2.3%)

 Chronic neurological disease

6 (0.7%)

9 (1.1%)

146 (0.8%)

26 (0.9%)

152 (0.8%)

35 (0.9%)

187 (0.8%)

 Diabetes, no complications

7 (0.8%)

10 (1.2%)

340 (1.8%)

46 (1.5%)

347 (1.7%)

56 (1.5%)

403 (1.7%)

 Diabetes with complications

0 (0%)

1 (0.1%)

54 (0.3%)

10 (0.3%)

54 (0.3%)

11 (0.3%)

65 (0.3%)

 Chronic blood disease

6 (0.7%)

5 (0.6%)

127 (0.7%)

11 (0.4%)

133 (0.7%)

16 (0.4%)

149 (0.6%)

 Rheumatic diseases

1 (0.1%)

3 (0.4%)

81 (0.4%)

12 (0.4%)

82 (0.4%)

15 (0.4%)

97 (0.4%)

 Dementia

0 (0%)

0 (0%)

26 (0.1%)

2 (< 0.1%)

26 (0.1%)

2 (< 0.1%)

28 (0.1%)

History of covid-19 n (%)

 No

804 (97.6%)

809 (97.2%)

17,162 (88.4%)

2814 (94.8%)

17,966 (88.8%)

3623 (95.3%)

21,589 (89.8%)

 Yes

20 (2.4%)

23 (2.8%)

2253 (11.6%)

154 (5.2%)

2273 (11.2%)

177 (4.7%)

2450 (10.2%)