Levin 2000.
Methods |
Study design: RCT, non‐blinded Duration: 36 months postvaccination |
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Participants |
Inclusion criteria Setting: outpatient Country: USA Number: 167 participants; treatment (N = 82), control (N = 85) Participants' health status: healthy participants with a history of varicella but not herpes zoster Age: mean ˜ 66 years Sex: ˜ 55% female Other relevant information: aged 55 to 89 years Exclusion criteria Immunosuppressive illness or medication |
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Interventions |
Treatment group
Control group
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Outcomes | Confirmed herpes zoster | |
Purpose of the study | "To compare a live attenuated varicella vaccine versus heat‐inactivated varicella vaccine in relation the confirmed cases of HZ and immunogenicity in individuals aged 55‐89 years" | |
Funding sources | Merck Research Laboratories, West Point, PA, USA | |
Conflicts of interest | Not described | |
Notes | Author answered our email and provided data for 1 clinical outcome. Most outcomes evaluated were immunologic. There is a misspelling of an author name on the paper: Dr Levin is referenced as Dr Levine. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
Selective reporting (reporting bias) | Unclear risk | Not described |
Other bias | Unclear risk | Insufficient information |