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. 2019 Nov 7;2019(11):CD008858. doi: 10.1002/14651858.CD008858.pub4

Comparison 2. Recombinant zoster vaccine versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Incidence of herpes zoster at least 3.2 years follow‐up 2 22022 Risk Ratio (M‐H, Random, 95% CI) 0.08 [0.03, 0.23]
2 Incidence of herpes zoster at least 4 years follow‐up 1   Risk Difference (M‐H, Random, 95% CI) Subtotals only
3 Participants with adverse events 2 307757 Risk Ratio (M‐H, Random, 95% CI) 3.35 [2.68, 4.19]
3.1 Death 2 29311 Risk Ratio (M‐H, Random, 95% CI) 0.94 [0.84, 1.04]
3.2 Death within 30 days after vaccination 1 15411 Risk Ratio (M‐H, Random, 95% CI) 1.15 [0.42, 3.16]
3.3 Serious AEs 2 29311 Risk Ratio (M‐H, Random, 95% CI) 0.97 [0.91, 1.03]
3.4 Serious AEs within 30 days after vaccination 1 15411 Risk Ratio (M‐H, Random, 95% CI) 0.90 [0.67, 1.20]
3.5 Serious AEs within 30 days after vaccination related to vaccination 1 15411 Risk Ratio (M‐H, Random, 95% CI) 0.33 [0.03, 3.21]
3.6 Any symptom 2 9936 Risk Ratio (M‐H, Random, 95% CI) 2.41 [2.02, 2.88]
3.7 Grade 3 any symptom 2 9936 Risk Ratio (M‐H, Random, 95% CI) 5.29 [4.48, 6.26]
3.8 Grade 3 any symptom related to vaccination 1 8926 Risk Ratio (M‐H, Random, 95% CI) 8.37 [6.69, 10.47]
3.9 Any systemic symptom 2 9762 Risk Ratio (M‐H, Random, 95% CI) 2.23 [2.12, 2.34]
3.10 Grade 3 any systemic AEs 2 9762 Risk Ratio (M‐H, Random, 95% CI) 4.29 [3.01, 6.11]
3.11 Potential immune‐mediated disease 2 29311 Risk Ratio (M‐H, Random, 95% CI) 0.88 [0.71, 1.08]
3.12 Myalgia 2 9762 Risk Ratio (M‐H, Random, 95% CI) 3.82 [3.52, 4.16]
3.13 Fatigue 2 9762 Risk Ratio (M‐H, Random, 95% CI) 2.51 [1.99, 3.17]
3.14 Headache 2 9762 Risk Ratio (M‐H, Random, 95% CI) 2.44 [2.26, 2.63]
3.15 Fever 2 9762 Risk Ratio (M‐H, Random, 95% CI) 6.45 [4.61, 9.04]
3.16 Shivering 2 9762 Risk Ratio (M‐H, Random, 95% CI) 4.35 [3.26, 5.81]
3.17 Gastrointestinal symptom 2 9762 Risk Ratio (M‐H, Random, 95% CI) 1.75 [1.21, 2.55]
3.18 Any local symptom 2 9769 Risk Ratio (M‐H, Random, 95% CI) 6.89 [6.37, 7.45]
3.19 Grade 3 any local symptom 2 9769 Risk Ratio (M‐H, Random, 95% CI) 12.69 [2.87, 56.06]
3.20 Local redness 2 9769 Risk Ratio (M‐H, Random, 95% CI) 28.93 [22.62, 37.00]
3.21 Local pain 2 9769 Risk Ratio (M‐H, Random, 95% CI) 7.14 [6.58, 7.74]
3.22 Local swelling 2 9769 Risk Ratio (M‐H, Random, 95% CI) 28.26 [15.91, 50.20]
3.23 Unsolicited report of AEs 1 8926 Risk Ratio (M‐H, Random, 95% CI) 1.07 [1.00, 1.14]
3.24 Grade 3 unsolicited report of AEs 1 8926 Risk Ratio (M‐H, Random, 95% CI) 1.38 [1.12, 1.69]
4 Dropouts 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
4.1 Did not receive vaccine according to protocol 2 29311 Risk Ratio (M‐H, Random, 95% CI) 1.15 [0.38, 3.54]
4.2 Received wrong vaccine 2 29311 Risk Ratio (M‐H, Random, 95% CI) 1.62 [0.81, 3.23]
4.3 Diagnosis of herpes zoster < 30 days after dose 2 2 29311 Risk Ratio (M‐H, Random, 95% CI) 0.32 [0.14, 0.71]
4.4 Did not receive second dose 2 29311 Risk Ratio (M‐H, Random, 95% CI) 1.25 [1.13, 1.39]