Evidence map›Paper›PMID 31216205›Full record

Trial reportHuman vaccines & immunotherapeutics2019

Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials.

Lidia Oostvogels, Thomas C Heineman, Robert W Johnson, Myron J Levin, Janet E McElhaney, Peter Van den Steen, Toufik Zahaf, Alemnew F Dagnew, Roman Chlibek, Javier Diez-Domingo and 13 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. 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 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01165177 phase3completednot on this map

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2015Enrolled16,165ConditionsHerpes ZosterArmsHerpes Zoster Vaccine GSK1437173A, Placebo
NCT01165229 phase3completednot on this map

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2015Enrolled14,819ConditionsHerpes Zoster, Herpes Zoster VaccineArmsHerpes Zoster Vaccine GSK1437173A, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 6 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Global herpes zoster burden in adults with COPD: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. [Zoster vaccination].Innere Medizin (Heidelberg, Germany) · 2024
    Article
  17. Article
  18. Article
  19. Review
  20. Review
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

23 authors at 14 institutions in 11 countries.

Lidia OostvogelsGSK, Wavre, Belgium.ORCID 0000-0003-1298-0360
Thomas C HeinemanGSK, King of Prussia, PA, USA.ORCID 0000-0003-4500-5676
Robert W JohnsonFaculty of Health Sciences, University of Bristol, Bristol, UK.ORCID 0000-0002-8376-7412
Myron J LevinDepartments of Pediatrics and Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.ORCID 0000-0002-7468-106X
Janet E McElhaneyHealth Sciences North Research Institute, Sudbury, Ontario, Canada.ORCID 0000-0002-0690-1446
Peter Van den SteenGSK, Wavre, Belgium.ORCID 0000-0001-7931-1781
Toufik ZahafGSK, Wavre, Belgium.ORCID 0000-0002-2049-5210
Alemnew F DagnewGSK, Rockville, MD, USA.ORCID 0000-0003-4181-058X
Roman ChlibekFaculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.ORCID 0000-0002-7387-3844
Javier Diez-DomingoFundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain.ORCID 0000-0003-1008-3922
Iris S GorfinkelPrimeHealth Clinical Research, Toronto, Ontario, Canada.ORCID 0000-0002-8812-941X
Caroline HervéGSK, Wavre, Belgium.
Shinn-Jang HwangDepartment of Family Medicine, Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taipei, Taiwan.ORCID 0000-0003-3217-6193
Hideyuki IkematsuJapan Physicians Association, Tokyo, Japan.ORCID 0000-0002-3548-4231
George KalemaKeyrus Biopharma, Waterloo, Belgium, on behalf of GSK.ORCID 0000-0002-0535-5930
Himal LalGSK, King of Prussia, PA, USA.ORCID 0000-0001-7174-1314
Shelly A McNeilCanadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie, University, Halifax, Canada.ORCID 0000-0001-5444-4166
Tomas MrkvanGSK, Wavre, Belgium.
Karlis PauksensDepartment of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.ORCID 0000-0003-2626-7574
Jan SmetanaFaculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.ORCID 0000-0002-3770-1754
Daisuke WatanabeDepartment of Dermatology, Aichi Medical University, Nagakute, Japan.ORCID 0000-0001-6817-3993
Lily Yin WeckxDepartment of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0003-4949-3582
Anthony L CunninghamThe Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0002-6744-5667
GlaxoSmithKline (Belgium) · BEUniversity of Defence · CZAichi Medical University · JPDalhousie University · CAFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESGlaxoSmithKline (United States) · USHealth Sciences North · CAJapan Medical Association · JPNational Yang Ming Chiao Tung University · TWThe University of Sydney · AUUniversidade Federal de São Paulo · BRUniversity of Bristol · GBUniversity of Colorado Anschutz Medical Campus · USUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

Indexed as

Vaccine PotencyAdjuvants, ImmunologicAgedChronic DiseaseComorbidityData Interpretation, StatisticalFemaleHerpes ZosterHerpes Zoster VaccineHumansImmunocompromised HostMaleMiddle AgedNeuralgia, PostherpeticRisk FactorsVaccinationAdjuvants, ImmunologicHerpes Zoster VaccineVaccines, Syntheticadjuvanted recombinant zoster vaccinecomorbidityunderlying chronic diseasevaccine efficacyvaccine safetyVaricella-zoster virus

Identifiers

PMID31216205
PMCPMC6930113
OpenAlexW2950051541

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.