Evidence map›Paper›PMID 30256905›Full record

Trial reportThe journals of gerontology. Series A, Biological sciences and medical sciences2019

The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial.

Kenneth E Schmader, Myron J Levin, Katrijn Grupping, Sean Matthews, David Butuk, Michael Chen, Mohamed El Idrissi, Laurence A Fissette, Charles Fogarty, Paul Hartley and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The journals of gerontology. Series A, Biological sciences and medical sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02979639 (Study to Evaluate the Impact of Reactogenicity on Quality of Life), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT02979639 phase3completednot on this map

Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled404ConditionsHerpes ZosterArmsGSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
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  5. Herpes Zoster in Aging Patients: Risk Factors and Prevention Strategies.International journal of general medicine · 2026
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

Kenneth E SchmaderDivision of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, North Carolina.
Myron J LevinDepartment of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora.
Katrijn GruppingGSK, Wavre, Belgium.
Sean MatthewsFreelance c/o GSK, Wavre, Belgium.
David ButukSolaris Clinical Research, Meridian, Idaho.
Michael ChenThe Corvallis Clinic, Oregon.
Mohamed El IdrissiGSK, Rixensart, Belgium.
Laurence A FissetteGSK, Wavre, Belgium.
Charles FogartySpartanburg Medical Research, South Carolina.
Paul HartleyPreferred Primary Care Physicians, Uniontown, Pennsylvania.
Nicola P KleinKaiser Permanente Vaccine Study Center, Oakland, California.
Max NevarezDaVita Medical Group, Colorado Springs, Colorado.
Kari UusinarkausDaVita Medical Group, Colorado Springs, Colorado.
Lidia OostvogelsGSK, Wavre, Belgium.
Desmond CurranGSK, Wavre, Belgium.
GlaxoSmithKline (Belgium) · BECorvallis Environmental Center · USGeriatric Research Education and Clinical Center · USKaiser Permanente Oakland Medical Center · USMeridian Clinical Research · USPreferred Family Healthcare · USSpartanburg Regional Medical Center · USUniversity of Colorado Anschutz Medical Campus · 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 and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and systemic reactions. This study assessed the impact of RZV on the quality of life and daily functioning of participants and implications for caregivers.

methodsFour hundred and one adults aged 50 years or older received single RZV doses at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2.

resultsThe most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%), and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%), and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased.

conclusionsOverall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.

Indexed as

Activities of Daily LivingQuality of LifeAgedFemaleHealth SurveysHerpes Zoster VaccineHumansMaleMiddle AgedUnited StatesVaccines, SyntheticHerpes Zoster VaccineVaccines, SyntheticPainPhysical activityPhysical functionRZV

Identifiers

PMID30256905
PMCPMC6625580
OpenAlexW2894495537

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.