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Table 1 Baseline characteristics of included randomized controlled trials

From: Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials

Study name

Vaccine platform

Study characteristics

Treatment allocation

Number of participants (safety data)

Age (years)

Sex (male)

Race (white, black, Asian)

Countries

Comorbidities

Polack, 2020 [3]

mRNA

Primary analysis of safety and efficacy from the phase 2/3 part of BNT162b2 in preventing symptomatic COVID-19 in persons ≥16 years Median follow-up: 2 months

BNT162b2 (30 μg), 2 doses 21 days apart

18,860 (21621)

52a (Range; 16–89)

51.1%

82.9, 9.2, 4.2%

US 76.7%, Argentina 15.3%, Brazil 6.1%

Diabetes 8.3%, chronic lung disease 7.8%, cancers 3.9%

Saline

18,846 (21631)

52a (Range; 16–91)

50.1%

82.9, 9.4, 4.3%

US 76.7%, Argentina 15.3%, Brazil 6.0%

Diabetes 8.4%, chronic lung disease 7.7%, cancers 3/5%

Baden, 2020 [4]

mRNA

Primary analysis of safety and efficacy of phase 3 RCT in preventing COVID-19 in persons ≥18 years Median follow-up: 63 days

mRNA-1273 (100 μg), 2 doses 28 days apart

15,170 (15166)

51.3b (Range; 18–95)

52.2%

79.2, 10.3, 4.3%

US 100%

Diabetes 9.5%, severe obesity 6.8%, cardiac disease 5%, chronic lung disease 4.7%

Saline

15,181 (15185)

51.4b (Range; 18–95)

53.1%

79.1, 10.1, 4.8%

US 100%

Diabetes 9.5%, severe obesity 6.7%, cardiac disease 4.9%, chronic lung disease 4.9%

Sadoff, 2021 [5]

Adenoviral vector

Primary analysis of safety and efficacy of phase 3 RCT in preventing COVID-19 in persons ≥18 years Median follow-up: 58 days

Ad26.COV2.S (A single dose of 5 × 1010 viral particles)

21,895

52a (Range; 19–100)

55.1%

58.7, 19.4, 3.4%

US 44.1%, Latin America 40.9%, South Africa 15.0%

Obesity 28.7%, hypertension 10.2%, diabetes 7.8%

Saline

21,888

52a (Range; 18–94)

54.7%

58.7, 19.5, 3.1%

US 44.1%, Latin America 40.9%, South Africa 15.0%

Obesity 28.4%, hypertension 10.5%, diabetes 7.7%

Voysey, 2021 [6]

Adenoviral vector

Interim analysis of 4 cohorts of phase 1/2/3 RCT parts in preventing COVID-19 in persons ≥18 years Median follow-up: 3.4 months

ChAdOx1 nCoV-19 (2.2–6.5 × 1010 viral particles, 2 doses 4- ≥12 weeks apart)

12,021

Age (18–55 years) 81.5%

44.2%

75.1, 10.0, 3.7%

UK 50.0%, Brazil 41.6%, South Africa 8.4%

Cardiovascular disease 12.6%, respiratory disease 9.9%, diabetes 2.8%

Meningococcal group A, C, W, and Y conjugate vaccine or saline

11,724

Age (18–55 years) 83.5%

44.1%

75.4, 10.2, 3.3%

UK 48.8%, Brazil 42.7%, South Africa 8.5%

Cardiovascular disease 12.0%, respiratory disease 10.0%, diabetes 2.5%

Logunov, 2021 [7]

Adenoviral vector

Preliminary efficacy and safety analysis of phase 3 RCT in preventing COVID-19 in persons ≥18 years Median follow-up: 48 days

rAd26 (1st dose) and rAd5 (2nd dose) containing 1 × 1011 viral particles, 2 doses 21 days apart

14,964 (16427)

45.3b (SD 12.0)

61.1%

98.5%, NA, 1.5%

Russia 100%

Diabetes, hypertension, ischemic heart disease, obesity 24.7%

Excipients

4902 (5435)

45.3b (SD 11.9)

61.5%

98.5%, NA, 1.5%

Russia 100%

Diabetes, hypertension, ischemic heart disease, obesity 25.2%

Tanriover, 2021 [8]

Inactivated

Interim analysis of efficacy and safety of phase 3 RCT in preventing COVID-19 in persons aged 18–59 years Median follow-up: 43 days

CoronaVac (3 μg of SARS-CoV-2 virions), 2 doses 14 days apart

6646 (6648)

45a (IQR; 35–51)

57.4%

NA

Turkey 100%

Hypertension 11.8%, diabetes 4.9%, chronic lung disease 2.9%

Aluminium hydroxide diluent

3568 (3568)

45a (IQR;37–51)

58.65

NA

Turkey 100%

Hypertension, 11.6%, diabetes 4.5%, chronic lung disease 2.9%

Palacios, 2021 [9] (preprint)

Inactivated

Interim analysis of efficacy and safety of phase 3 RCT in preventing COVID-19 in healthcare workers ≥18 years Median follow-up: 2 months after the second dose

CoronaVac (3 μg of SARS-CoV-2 virions), 2 doses 14 days apart

6195 (6202)

39.4b (SD 10.7)

36.6%

75.8, 5.3, 2.4%

Brazil 100%

Obesity 22.4%, cardiovascular disease 12.8%, diabetes 3.5%

Aluminium hydroxide diluent

6201 (6194)

39.6b (SD 10.8)

35.0%

74.8, 5.2, 2.6%

Brazil 100%

Obesity 22.6%, cardiovascular disease 12.5%, diabetes 3.2%

Heath, 2021 [10]

Protein subunit

Interim analysis of efficacy and safety of phase 3 RCT in preventing COVID-19 in persons ≥18 years Median follow-up: 66 days after the first dose and 45 days after the second dose

NVX-CoV2373 (5 μg), 2 doses 21 days apart

7020 (7569)

56a (18–84)

51.4%

94.4, 0.4, 2.9%

UK 100%

Chronic lung, cardiac, renal, neurologic, hepatic, immunocompromising conditions, and obesity 44.4%

Saline

7019 (7570)

56a (18–64)

51.7%

94.5, 0.4, 3.0%

UK 100%

Chronic lung, cardiac, renal, neurologic, hepatic, immunocompromising conditions, and obesity 44.8%

  1. aMedian; bMean; COVID-19, coronavirus disease 2019; RCT randomized controlled trial; US United States; UK United Kingdom