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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.
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Number of Authors: 552019 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 37, no 18, p. 2482-2493Article in journal (Refereed) 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

Place, publisher, year, edition, pages
Elsevier Ltd , 2019. Vol. 37, no 18, p. 2482-2493
Keywords [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
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
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
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open access

Available from: 2019-04-18 Created: 2019-04-18 Last updated: 2019-06-14Bibliographically approved

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Sanmartin Berglund, Johan

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