Ändra sökning
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf
Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials
GSK, Wavre, BEL.
GSK, Wavre, BEL.
GSK, Wavre, BEL.
GSK, Rixensart, BEL.
Visa övriga samt affilieringar
Antal upphovsmän: 552019 (Engelska)Ingår i: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 37, nr 18, s. 2482-2493Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA

Ort, förlag, år, upplaga, sidor
Elsevier Ltd , 2019. Vol. 37, nr 18, s. 2482-2493
Nyckelord [en]
Reactogenicity, Safety, Vaccine, Varicella-zoster virus, placebo, varicella zoster vaccine, acute kidney failure, adult, age distribution, aged, alopecia areata, aortic stenosis, arthralgia, Article, atrial fibrillation, autoimmune pancreatitis, autoimmune thyroiditis, backache, brain infarction, cardiogenic shock, cardiopulmonary insufficiency, celiac disease, cerebrovascular accident, chill, chronic gastritis, chronic obstructive lung disease, clinical evaluation, cohort analysis, controlled study, coughing, Crohn disease, disease course, dizziness, drug efficacy, drug safety, erythema nodosum, facial nerve paralysis, fatigue, female, fever, fibrosing alveolitis, follow up, glomerulonephritis, Graves disease, Guillain Barre syndrome, headache, heart atrium flutter, heart failure, heart infarction, herpes zoster, human, idiopathic thrombocytopenic purpura, immunoglobulin A nephropathy, information processing, injection site erythema, injection site pain, injection site pruritus, injection site swelling, injection site warmth, insulin dependent diabetes mellitus, lichen planus, lung fibrosis, lung tumor, major clinical study, malaise, male, mixed connective tissue disease, multiple organ failure, multiple sclerosis, myalgia, neuritis, oropharynx pain, pancreas carcinoma, paraneoplastic neuropathy, pemphigus, phase 3 clinical trial, pneumonia, polyradiculoneuropathy, population research, priority journal, psoriasis, psoriatic arthritis, race, radiculitis, randomized controlled trial, Raynaud phenomenon, respiratory failure, retina detachment, rheumatic polymyalgia, rheumatoid arthritis, rhinopharyngitis, sepsis, septic shock, sex ratio, single blind procedure, spondyloarthropathy, supraventricular tachycardia, syndrome CREST, systemic juvenile idiopathic arthritis, systemic lupus erythematosus, tachycardia, temporal arteritis, trigeminal nerve disease, trigeminus neuralgia, ulcerative colitis, upper respiratory tract infection, uveitis, vaccination, vitiligo
Nationell ämneskategori
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi
Identifikatorer
URN: urn:nbn:se:bth-17834DOI: 10.1016/j.vaccine.2019.03.043ISI: 000466622500009Scopus ID: 2-s2.0-85063476515OAI: oai:DiVA.org:bth-17834DiVA, id: diva2:1305747
Anmärkning

open access

Tillgänglig från: 2019-04-18 Skapad: 2019-04-18 Senast uppdaterad: 2019-06-14Bibliografiskt granskad

Open Access i DiVA

fulltext(485 kB)49 nedladdningar
Filinformation
Filnamn FULLTEXT01.pdfFilstorlek 485 kBChecksumma SHA-512
1c2f88014e01457ad2d940a4cd0fc62770833f22ec4923f39383ee9ab1f586759767e86b8724a32eb13dd1338bf0e842e904394eea374fdc4202b781dec5af6b
Typ fulltextMimetyp application/pdf

Övriga länkar

Förlagets fulltextScopus

Personposter BETA

Sanmartin Berglund, Johan

Sök vidare i DiVA

Av författaren/redaktören
Sanmartin Berglund, Johan
Av organisationen
Institutionen för hälsa
I samma tidskrift
Vaccine
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi

Sök vidare utanför DiVA

GoogleGoogle Scholar
Totalt: 49 nedladdningar
Antalet nedladdningar är summan av nedladdningar för alla fulltexter. Det kan inkludera t.ex tidigare versioner som nu inte längre är tillgängliga.

doi
urn-nbn

Altmetricpoäng

doi
urn-nbn
Totalt: 129 träffar
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf