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

Comparison 1. Live zoster vaccine versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Incidence of herpes zoster 1   Risk Ratio (M‐H, Random, 95% CI) Totals not selected
1.1 3.1 years follow‐up 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
1.2 30 days of vaccination 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
1.3 42 days of vaccination 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
1.4 3.3 to 7.8 years after vaccination substudy 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
1.5 Mean 5 years follow‐up 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
2 Interference of herpes zoster in activities of daily life 1   Risk Ratio (M‐H, Random, 95% CI) Totals not selected
3 Participants with adverse events 6   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
3.1 Death 5 50820 Risk Ratio (M‐H, Random, 95% CI) 1.01 [0.92, 1.11]
3.2 1 or more serious adverse events regardless of type of storage of the vaccine 6 51029 Risk Ratio (M‐H, Random, 95% CI) 1.08 [0.95, 1.21]
3.3 Vaccine‐related serious adverse events 4 50766 Risk Ratio (M‐H, Random, 95% CI) 0.99 [0.24, 4.15]
3.4 Hospitalised 1 6616 Risk Ratio (M‐H, Random, 95% CI) 1.00 [0.93, 1.07]
3.5 Hospitalisation related to herpes zoster 1 6616 Risk Ratio (M‐H, Random, 95% CI) 0.81 [0.25, 2.67]
3.6 1 or more adverse events 5 7119 Risk Ratio (M‐H, Random, 95% CI) 1.71 [1.38, 2.11]
3.7 Vaccine‐related adverse events 3 342 Risk Ratio (M‐H, Random, 95% CI) 2.64 [1.21, 5.75]
3.8 Systemic adverse events 5 7119 Risk Ratio (M‐H, Random, 95% CI) 1.24 [0.82, 1.87]
3.9 Vaccine‐related systemic adverse events 3 6856 Risk Ratio (M‐H, Random, 95% CI) 1.30 [1.07, 1.58]
3.10 Systemic pruritus 2 263 Risk Ratio (M‐H, Random, 95% CI) 1.61 [0.12, 22.42]
3.11 General malaise 1 54 Risk Ratio (M‐H, Random, 95% CI) 1.0 [0.07, 15.18]
3.12 Headache 1 78 Risk Ratio (M‐H, Random, 95% CI) 1.0 [0.15, 6.75]
3.13 Varicella‐like rash not at injection site (day of vaccination to day 42) 3 38833 Risk Ratio (M‐H, Random, 95% CI) 1.10 [0.57, 2.11]
3.14 Rash unrelated to herpes zoster (day of vaccination to day 42) 2 38624 Risk Ratio (M‐H, Random, 95% CI) 0.97 [0.80, 1.18]
3.15 Injection site adverse events 4 7040 Risk Ratio (M‐H, Random, 95% CI) 3.73 [1.93, 7.21]
3.16 Erythema inoculation site 4 6958 Risk Ratio (M‐H, Random, 95% CI) 4.30 [2.66, 6.94]
3.17 Pain inoculation site 4 6958 Risk Ratio (M‐H, Random, 95% CI) 6.47 [2.67, 15.68]
3.18 Pruritus inoculation site 4 6958 Risk Ratio (M‐H, Random, 95% CI) 4.32 [1.49, 12.48]
3.19 Swelling inoculation site 3 6879 Risk Ratio (M‐H, Random, 95% CI) 5.84 [4.95, 6.89]
3.20 Warmth inoculation site 3 6879 Risk Ratio (M‐H, Random, 95% CI) 4.73 [2.57, 8.74]
3.21 Rash inoculation site 1 6616 Risk Ratio (M‐H, Random, 95% CI) 3.26 [1.31, 8.11]
3.22 Haematoma inoculation site 1 6616 Risk Ratio (M‐H, Random, 95% CI) 1.13 [0.76, 1.67]
3.23 Mass inoculation or induration site 2 6695 Risk Ratio (M‐H, Random, 95% CI) 7.05 [1.91, 26.05]
3.24 Varicella‐like rash at injection site (day of vaccination to day 42) 1 38546 Risk Ratio (M‐H, Random, 95% CI) 2.86 [1.21, 6.76]
3.25 Vaccine‐unrelated adverse event 1 54 Risk Ratio (M‐H, Random, 95% CI) 0.67 [0.12, 3.68]
3.26 Herpes zoster‐like rash (day of vaccination to day 42) 1 38546 Risk Ratio (M‐H, Random, 95% CI) 0.47 [0.27, 0.84]
4 Duration in days of adverse effects 1   Mean Difference (IV, Random, 95% CI) Totals not selected
4.1 Erythema 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
4.2 Pain 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
4.3 Pruritus 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
4.4 Swelling 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
4.5 Rash 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
4.6 Haematoma 1   Mean Difference (IV, Random, 95% CI) 0.0 [0.0, 0.0]
5 Dropouts 6   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
5.1 For any reason 3 38916 Risk Ratio (M‐H, Random, 95% CI) 0.99 [0.91, 1.08]
5.2 Discontinued due to vaccine‐related adverse events 2 370 Risk Ratio (M‐H, Random, 95% CI) 5.05 [0.25, 103.88]
5.3 Clinical adverse event 2 12189 Risk Ratio (M‐H, Random, 95% CI) 1.34 [0.72, 2.52]
5.4 Physician decision 1 11980 Risk Ratio (M‐H, Random, 95% CI) 0.20 [0.01, 4.17]
5.5 Withdrew consent 4 50814 Risk Ratio (M‐H, Random, 95% CI) 0.95 [0.54, 1.68]
5.6 Lost to follow‐up 5 50868 Risk Ratio (M‐H, Random, 95% CI) 1.27 [0.96, 1.69]
5.7 Protocol deviation 2 12189 Risk Ratio (M‐H, Random, 95% CI) 1.49 [0.27, 8.37]
6 Participants with no follow‐up 3 50627 Risk Ratio (M‐H, Random, 95% CI) 0.85 [0.41, 1.74]