WFRF:(Vesikari T.)
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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 12505naa a2202317 4500 | |
| 001 | oai:DiVA.org:bth-17834 | |
| 003 | SwePub | |
| 008 | 190418s2019 | |||||||||||000 ||eng| | |
| 009 | oai:DiVA.org:uu-387212 | |
| 024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:bth-178342 URI |
| 024 | 7 | a https://doi.org/10.1016/j.vaccine.2019.03.0432 DOI |
| 024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3872122 URI |
| 040 | a (SwePub)bthd (SwePub)uu | |
| 041 | a engb eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a López-Fauqued, M.u GSK, Ave Fleming 20, B-1300 Wavre, Belgium4 aut |
| 245 | 1 0 | a Safety profile of the adjuvanted recombinant zoster vaccine :b Pooled analysis of two large randomised phase 3 trials |
| 264 | 1 | b Elsevier Ltd,c 2019 |
| 338 | a electronic2 rdacarrier | |
| 500 | a open access | |
| 520 | a 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 | |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Hälsovetenskapx Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi0 (SwePub)303022 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Health Sciencesx Public Health, Global Health, Social Medicine and Epidemiology0 (SwePub)303022 hsv//eng |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Allmänmedicin0 (SwePub)302242 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex General Practice0 (SwePub)302242 hsv//eng |
| 653 | a Reactogenicity | |
| 653 | a Safety | |
| 653 | a Vaccine | |
| 653 | a Varicella-zoster virus | |
| 653 | a placebo | |
| 653 | a varicella zoster vaccine | |
| 653 | a acute kidney failure | |
| 653 | a adult | |
| 653 | a age distribution | |
| 653 | a aged | |
| 653 | a alopecia areata | |
| 653 | a aortic stenosis | |
| 653 | a arthralgia | |
| 653 | a Article | |
| 653 | a atrial fibrillation | |
| 653 | a autoimmune pancreatitis | |
| 653 | a autoimmune thyroiditis | |
| 653 | a backache | |
| 653 | a brain infarction | |
| 653 | a cardiogenic shock | |
| 653 | a cardiopulmonary insufficiency | |
| 653 | a celiac disease | |
| 653 | a cerebrovascular accident | |
| 653 | a chill | |
| 653 | a chronic gastritis | |
| 653 | a chronic obstructive lung disease | |
| 653 | a clinical evaluation | |
| 653 | a cohort analysis | |
| 653 | a controlled study | |
| 653 | a coughing | |
| 653 | a Crohn disease | |
| 653 | a disease course | |
| 653 | a dizziness | |
| 653 | a drug efficacy | |
| 653 | a drug safety | |
| 653 | a erythema nodosum | |
| 653 | a facial nerve paralysis | |
| 653 | a fatigue | |
| 653 | a female | |
| 653 | a fever | |
| 653 | a fibrosing alveolitis | |
| 653 | a follow up | |
| 653 | a glomerulonephritis | |
| 653 | a Graves disease | |
| 653 | a Guillain Barre syndrome | |
| 653 | a headache | |
| 653 | a heart atrium flutter | |
| 653 | a heart failure | |
| 653 | a heart infarction | |
| 653 | a herpes zoster | |
| 653 | a human | |
| 653 | a idiopathic thrombocytopenic purpura | |
| 653 | a immunoglobulin A nephropathy | |
| 653 | a information processing | |
| 653 | a injection site erythema | |
| 653 | a injection site pain | |
| 653 | a injection site pruritus | |
| 653 | a injection site swelling | |
| 653 | a injection site warmth | |
| 653 | a insulin dependent diabetes mellitus | |
| 653 | a lichen planus | |
| 653 | a lung fibrosis | |
| 653 | a lung tumor | |
| 653 | a major clinical study | |
| 653 | a malaise | |
| 653 | a male | |
| 653 | a mixed connective tissue disease | |
| 653 | a multiple organ failure | |
| 653 | a multiple sclerosis | |
| 653 | a myalgia | |
| 653 | a neuritis | |
| 653 | a oropharynx pain | |
| 653 | a pancreas carcinoma | |
| 653 | a paraneoplastic neuropathy | |
| 653 | a pemphigus | |
| 653 | a phase 3 clinical trial | |
| 653 | a pneumonia | |
| 653 | a polyradiculoneuropathy | |
| 653 | a population research | |
| 653 | a priority journal | |
| 653 | a psoriasis | |
| 653 | a psoriatic arthritis | |
| 653 | a race | |
| 653 | a radiculitis | |
| 653 | a randomized controlled trial | |
| 653 | a Raynaud phenomenon | |
| 653 | a respiratory failure | |
| 653 | a retina detachment | |
| 653 | a rheumatic polymyalgia | |
| 653 | a rheumatoid arthritis | |
| 653 | a rhinopharyngitis | |
| 653 | a sepsis | |
| 653 | a septic shock | |
| 653 | a sex ratio | |
| 653 | a single blind procedure | |
| 653 | a spondyloarthropathy | |
| 653 | a supraventricular tachycardia | |
| 653 | a syndrome CREST | |
| 653 | a systemic juvenile idiopathic arthritis | |
| 653 | a systemic lupus erythematosus | |
| 653 | a tachycardia | |
| 653 | a temporal arteritis | |
| 653 | a trigeminal nerve disease | |
| 653 | a trigeminus neuralgia | |
| 653 | a ulcerative colitis | |
| 653 | a upper respiratory tract infection | |
| 653 | a uveitis | |
| 653 | a vaccination | |
| 653 | a vitiligo | |
| 700 | 1 | a Campora, L.u GSK, Ave Fleming 20, B-1300 Wavre, Belgium4 aut |
| 700 | 1 | a Delannois, F.u GSK, Ave Fleming 20, B-1300 Wavre, Belgium4 aut |
| 700 | 1 | a El Idrissi, M.u GSK, Rixensart, BEL,GSK, Rixensart, Belgium4 aut |
| 700 | 1 | a Oostvogels, L.u GSK, Ave Fleming 20, B-1300 Wavre, Belgium;CureVac AG, Tubingen, Germany4 aut |
| 700 | 1 | a De Looze, F. J.u University of Queensland, AUS,AusTrials Pty Ltd, Sherwood, Qld, Australia;Univ Queensland, Sch Med, Brisbane, Qld, Australia4 aut |
| 700 | 1 | a Diez-Domingo, J.u Fundación para el Fomento de la Investigación Sanitaria y Biomédica, ESP,Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain4 aut |
| 700 | 1 | a Heineman, T. C.u GSK, King Of Prussia, PA USA;Halozyme Therapeut, San Diego, CA USA,Hosp Clin San Carlos, Madrid, Spain4 aut |
| 700 | 1 | a Lal, H.u GSK, King Of Prussia, PA USA;Pfizer Vaccine Inc, Collegeville, PA USA4 aut |
| 700 | 1 | a McElhaney, J. E.u ealth Sciences North Research Institute, CAN,Hlth Sci North Res Inst, Sudbury, ON, Canada,GSK, Brussels, Belgium4 aut |
| 700 | 1 | a McNeil, S. A.u Dalhousie University, CAN,Dalhousie Univ, Canadian Ctr Vaccinol, Halifax, NS, Canada;Dalhousie Univ, IWK Hlth Ctr, Halifax, NS, Canada;Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada,Univ Tampere, Jarvenpaa Vaccine Clin, Tampere, Finland,University of Tampere, FIN4 aut |
| 700 | 1 | a Yeo, W.u University of Wollongong, AUS,Univ Wollongong, Sch Med, Wollongong, NSW, Australia4 aut |
| 700 | 1 | a Tavares-Da-Silva, F.u GSK, Ave Fleming 20, B-1300 Wavre, Belgium4 aut |
| 700 | 1 | a Ahonen, A.u University of Tampere, FIN4 aut |
| 700 | 1 | a Avelino-Silva, T. J.u University of São Paulo, BRA,Univ Sao Paulo, Sch Med, Sao Paulo, Brazil4 aut |
| 700 | 1 | a Barba-Gomez, J. F.u Instituto Dermatológico de Jalisco, MEX,Inst Dermatol Jalisco, Guadalajara, Jalisco, Mexico4 aut |
| 700 | 1 | a Sanmartin Berglund, Johan,c Professoru Blekinge Tekniska Högskola,Institutionen för hälsa,Blekinge Inst Technol, Karlskrona, Sweden4 aut0 (Swepub:bth)jbu |
| 700 | 1 | a Brotons Cuixart, Carlosu EAP Sardenya, Barcelona, Spain4 aut |
| 700 | 1 | a Chlibek, Romanu Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic4 aut |
| 700 | 1 | a Choi, Won Suku Korea Univ, Coll Med, Seoul, South Korea4 aut |
| 700 | 1 | a Cunningham, Anthony L.u Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia4 aut |
| 700 | 1 | a Desole, Maria Guiseppinau Serv Igiene Pubbl, Sassari, Italy4 aut |
| 700 | 1 | a Eizenberg, Peteru Doctors Ivanhoe, Ivanhoe, Australia4 aut |
| 700 | 1 | a Esen, Meralu Univ Clin Tubingen, Inst Tropenmed, Tubingen, Germany4 aut |
| 700 | 1 | a Gervais, Pierreu Q&T Res Sherbrooke, Sherbrooke, PQ, Canada4 aut |
| 700 | 1 | a Ghesquiere, Wayneu Univ British Columbia, Vancouver, BC, Canada4 aut |
| 700 | 1 | a Godeaux, Olivieru GSK, Brussels, Belgium4 aut |
| 700 | 1 | a Gorfinkel, Irisu York Univ, N York, ON, Canada4 aut |
| 700 | 1 | a Hui, David Shu Cheongu Prince Wales Hosp, Hong Kong, Peoples R China4 aut |
| 700 | 1 | a Hwang, Shinn-Jangu Taipei Vet Gen Hosp, Taipei, Taiwan;Natl Yang Ming Univ, Sch Med, Taipei, Taiwan4 aut |
| 700 | 1 | a Korhonen, Tiinau Univ Tampere, Sch Med, Vaccine Res Ctr, Tampere, Finland4 aut |
| 700 | 1 | a Kovac, Martinau GSK, New York, NY USA4 aut |
| 700 | 1 | a Ledent, Edouardu GSK, Rixensart, Belgium4 aut |
| 700 | 1 | a Leung, Edwardu Hong Kong Assoc Gerontol, Hong Kong, Peoples R China4 aut |
| 700 | 1 | a Levin, Myron J.u Univ Colorado, Anschutz Med Campus, Aurora, CO USA4 aut |
| 700 | 1 | a Narejos Perez, Silviau CAP Centelles, Centelles, Spain4 aut |
| 700 | 1 | a Neto, Jose Luizu Inst AZ Pesquisa & Ensino, Curitiba, Parana, Brazil4 aut |
| 700 | 1 | a Pauksen, Karlisu Uppsala universitet,Infektionssjukdomar4 aut0 (Swepub:uu)karlpauk |
| 700 | 1 | a Poder, Airiu Kliiniliste Uuringute Keskus, Tartu, Estonia4 aut |
| 700 | 1 | a Rodriguez de la Pinta, Maria Luisau Hosp Puerta de Hierro, Madrid, Spain4 aut |
| 700 | 1 | a Rombo, Larsu Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD)4 aut0 (Swepub:uu)larra728 |
| 700 | 1 | a Schwarz, Tino F.u Standort Juliusspital, Wurzburg, Germany4 aut |
| 700 | 1 | a Smetana, Janu Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic4 aut |
| 700 | 1 | a Staniscia, Tommasou Univ G dAnnunzio, Chieti, Italy4 aut |
| 700 | 1 | a Tinoco, Juan Carlosu Hosp Gen Durango, Durango, Mexico4 aut |
| 700 | 1 | a Toma, Azharu Manna Res, Toronto, ON, Canada4 aut |
| 700 | 1 | a Vastiau, Ilseu GSK, Ave Fleming 20, B-1300 Wavre, Belgium4 aut |
| 700 | 1 | a Vesikari, Timou Univ Tampere, Tampere, Finland4 aut |
| 700 | 1 | a Volpi, Antoniou AO Univ Policlin Tor Vergata, Rome, Italy4 aut |
| 700 | 1 | a Watanabe, Daisukeu Kobe Univ, Grad Sch Med, Kobe, Hyogo, Japan4 aut |
| 700 | 1 | a Weckx, Lily Yinu Univ Fed Sao Paulo, Sao Paulo, Brazil4 aut |
| 700 | 1 | a Zahaf, Toufiku GSK, Brussels, Belgium4 aut |
| 710 | 2 | a GSK, Ave Fleming 20, B-1300 Wavre, Belgiumb GSK, Rixensart, BEL4 org |
| 773 | 0 | t Vaccined : Elsevier Ltdg 37:18, s. 2482-2493q 37:18<2482-2493x 0264-410Xx 1873-2518 |
| 856 | 4 | u https://doi.org/10.1016/j.vaccine.2019.03.043y Fulltext |
| 856 | 4 | u https://bth.diva-portal.org/smash/get/diva2:1305747/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print |
| 856 | 4 | u https://doi.org/10.1016/j.vaccine.2019.03.043 |
| 856 | 4 | u https://uu.diva-portal.org/smash/get/diva2:1330190/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print |
| 856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:bth-17834 |
| 856 | 4 8 | u https://doi.org/10.1016/j.vaccine.2019.03.043 |
| 856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-387212 |
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- Diez-Domingo, J.
- Heineman, T. C.
- Lal, H.
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- Eizenberg, Peter
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- Godeaux, Olivier
- Gorfinkel, Iris
- Hui, David Shu C ...
- Hwang, Shinn-Jan ...
- Korhonen, Tiina
- Kovac, Martina
- Ledent, Edouard
- Leung, Edward
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- Narejos Perez, S ...
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