Evidence map›Paper›PMID 22291101›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years.

Kenneth E Schmader, Myron J Levin, John W Gnann, Shelly A McNeil, Timo Vesikari, Robert F Betts, Susan Keay, Jon E Stek, Nickoya D Bundick, Shu-Chih Su and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 204 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
204citing papers in PubMed, 6 pooled it
25.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00534248 phase3completednot on this map

A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2010Enrolled22,439ConditionsShinglesArmsZoster Vaccine, Live (Zostavax™), Comparator: Placebo
NCT03016884 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation

TypeinterventionalSponsorHaEmek Medical Center, IsraelRan2017 to 2020Enrolled87ConditionsHerpes ZosterArmsZostavax vaccine
3 · Its place in the literature

Who cites it

204 citing papers in PubMed, 6 syntheses or guidelines pooled it, 430 citations in OpenAlex.

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  20. Informing decisions in light of parameter uncertainty - an economic evaluation of the adjuvanted recombinant herpes zoster vaccine in Sweden.The European journal of health economics : HEPAC : health economics in prevention and care · 2026
    Article

144 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 3 countries.

Kenneth E SchmaderDuke University, North Carolina, USA.
Myron J Levin
John W Gnann
Shelly A McNeil
Timo Vesikari
Robert F Betts
Susan Keay
Jon E Stek
Nickoya D Bundick
Shu-Chih Su
Yanli Zhao
Xiaoming Li
Ivan S F Chan
Paula W Annunziato
Janie Parrino
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDalhousie University · CADuke University · USTampere University · FIUniversity of Alabama at Birmingham · USUniversity of Colorado Denver · USUniversity of Rochester · USVA Maryland Health Care System · US

Funding

Resource Core 3 - Metabolomics CoreP30AG028716 · NIA · DUKE UNIVERSITY · PI Virginia B Kraus · 2006 to 2026
$24.6M
NIA NIH HHS P30 AG028716
6 · The paper itself

Abstract

backgroundHerpes zoster (HZ) adversely affects individuals aged 50-59, but vaccine efficacy has not been assessed in this population. This study was designed to determine the efficacy, safety, and tolerability of zoster vaccine for preventing HZ in persons aged 50-59 years.

methodsThis was a randomized, double-blind, placebo-controlled study of 22 439 subjects aged 50-59 years conducted in North America and Europe. Subjects were given 1 dose of licensed zoster vaccine (ZV) (Zostavax; Merck) and followed for occurrence of HZ for ≥1 year (mean, 1.3 years) postvaccination until accrual of ≥96 confirmed HZ cases (as determined by testing lesions swabs for varicella zoster virus DNA by polymerase chain reaction). Subjects were followed for all adverse events (AEs) from day 1 to day 42 postvaccination and for serious AEs (SAEs) through day 182 postvaccination.

resultsThe ZV reduced the incidence of HZ (30 cases in vaccine group, 1.99/1000 person-years vs 99 cases in placebo group, 6.57/1000 person-years). Vaccine efficacy for preventing HZ was 69.8% (95% confidence interval, 54.1-80.6). AEs were reported by 72.8% of subjects in the ZV group and 41.5% in the placebo group, with the difference primarily due to higher rates of injection-site AEs and headache. The proportion of subjects reporting SAEs occurring within 42 days postvaccination (ZV, 0.6%; placebo, 0.5%) and 182 days postvaccination (ZV, 2.1%; placebo, 1.9%) was similar between groups.

conclusionsIn subjects aged 50-59 years, the ZV significantly reduced the incidence of HZ and was well tolerated. CLINICAL TRIALS REGISTRATION: NCT00534248.

Indexed as

Double-Blind MethodDrug-Related Side Effects and Adverse ReactionsEuropeFemaleHerpes ZosterHerpes Zoster VaccineHumansIncidenceMaleMiddle AgedNorth AmericaPlacebosHerpes Zoster VaccinePlacebos

Identifiers

PMID22291101
PMCPMC4542655
OpenAlexW2149820050

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.