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. 2016 Mar 3;2016(3):CD008858. doi: 10.1002/14651858.CD008858.pub3

Summary of findings for the main comparison.

Available live attenuated VZV zoster vaccine versus placebo for preventing herpes zoster in older adults

Available live attenuated VZV zoster vaccine versus placebo for preventing herpes zoster in older adults
Patient or population: healthy older adults
Settings: outpatients
Intervention: available live attenuated VZV zoster vaccine
Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) No of participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk Corresponding risk
Placebo Available live attenuated VZV zoster vaccine
Incidence of herpes zoster
Clinical and laboratory criteria Follow‐up: median 3.1 years
Study population RR 0.49 (0.43 to 0.56) 38,546 (1 study) ⊕⊕⊕⊝ moderate1 Absolute risk for available live attenuated VZV zoster vaccine = 1.6%
Absolute risk for placebo group = 3.3%
33 per 1000 16 per 1000 (14 to 19)
Participants with AEs: ≥ 1 serious AE regardless of type of storage of the vaccine
Clinical and laboratory criteria Follow‐up: median 3.1 years
Study population RR 1.08 (0.96 to 1.2) 50,896 (4 studies) ⊕⊕⊕⊝ moderate1 Absolute risk for available live attenuated VZV zoster vaccine = 2.3%
Absolute risk for placebo group = 2.2%
22 per 1000 23 per 1000 (21 to 26)
Participants with AEs: hospitalised
Number of participants hospitalised Follow‐up: median 3.1 years
Study population RR 1.00 (0.93 to 1.07) 6616 (1 study) ⊕⊕⊕⊝ moderate1 Absolute risk for available live attenuated VZV zoster vaccine = 34.1%
Absolute risk for placebo group = 34.1%
341 per 1000 341 per 1000 (317 to 365)
Participants with AEs: injection site AEs
Clinical and laboratory criteria Follow‐up: median 3.1 years
Study population RR 2.99 (2.75 to 3.26) 6986 (3 studies) ⊕⊕⊕⊝ moderate1 Absolute risk for available live attenuated VZV zoster vaccine = 47.9%
Absolute risk for placebo group = 16.0%
160 per 1000 479 per 1000 (440 to 521)
Drop‐outs: death
Number of deaths Follow‐up: median 3.1 years
Study population RR 1.01 (0.92 to 1.11) 50,687 (3 studies) ⊕⊕⊕⊝ moderate1 Absolute risk for available live attenuated VZV zoster vaccine = 3.3%
Absolute risk for placebo group = 3.2%
32 per 1000 33 per 1000 (30 to 36)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AE: adverse event; CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

1Did not describe random sequence generation.