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Efficacy of the Her...
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Cunningham, A. L.Westmead Inst Med Res, Westmead, NSW, Australia.;Univ Sydney, Sydney, NSW, Australia.
(författare)
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
- Artikel/kapitelEngelska2016
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Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-305455
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-305455URI
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https://doi.org/10.1056/NEJMoa1603800DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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BACKGROUND A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01(B) adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). METHODS This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1: 1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. RESULTS In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. CONCLUSIONS In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.govnumbers, NCT01165177 and NCT01165229.)
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Lal, H.GSK Vaccines, King Of Prussia, PA USA.
(författare)
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Kovac, M.GSK Vaccines, Wavre, Belgium.
(författare)
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Chlibek, R.Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.
(författare)
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Hwang, S. -J
(författare)
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Diez-Domingo, J.Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.
(författare)
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Godeaux, O.GSK Vaccines, Wavre, Belgium.
(författare)
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Levin, M. J.Univ Colorado, Dept Pediat, Anschutz Med Campus, Aurora, CO USA.;Univ Colorado, Dept Med, Anschutz Med Campus, Aurora, CO USA.
(författare)
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McElhaney, J. E.Hlth Sci North Res Inst, Sudbury, ON, Canada.
(författare)
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Puig-Barbera, J.Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.
(författare)
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Abeele, C. VandenGSK Vaccines, Wavre, Belgium.
(författare)
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Vesikari, T.Univ Tampere, Vaccine Res Ctr, Tampere, Finland.
(författare)
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Watanabe, D.Aichi Med Univ, Dept Dermatol, Nagakute, Aichi, Japan.
(författare)
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Zahaf, T.GSK Vaccines, Wavre, Belgium.
(författare)
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Ahonen, A.Univ Tampere, Vaccine Res Ctr, Tampere, Finland.
(författare)
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Athan, E.Deakin Univ, Barwon Hlth, Dept Infect Dis, Geelong, Vic, Australia.
(författare)
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Barba-Gomez, J. F.Inst Dermatol Jalisco Dr Jose Barba Rubio, Zapopan, Mexico.
(författare)
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Campora, L.GSK Vaccines, Wavre, Belgium.
(författare)
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de Looze, F.Univ Queensland, Sch Med, AusTrials, Brisbane, Qld, Australia.;Univ Queensland, Sch Med, Discipline Gen Practice, Brisbane, Qld, Australia.
(författare)
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Downey, H. J.Jacksonville Ctr Clin Res, Jacksonville, FL USA.
(författare)
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Ghesquiere, W.Univ British Columbia, Infect Dis Sect, Victoria, BC, Canada.
(författare)
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Gorfinkel, I.PrimeHlth Clin Res, Toronto, ON, Canada.
(författare)
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Korhonen, T.Univ Tampere, Vaccine Res Ctr, Tampere, Finland.
(författare)
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Leung, E.United Christian Hosp, Dept Med & Geriatr, Div Geriatr Med, Hong Kong, Hong Kong, Peoples R China.
(författare)
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McNeil, S. A.Dalhousie Univ, IWK Hlth Ctr, Canadian Ctr Vaccinol, Halifax, NS, Canada.;Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada.
(författare)
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Oostvogels, L.GSK Vaccines, Wavre, Belgium.
(författare)
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Rombo, LarsUppsala universitet,Medicinska fakulteten,Centrum för klinisk forskning i Sörmland (CKFD),Sormland Cty Council, Clin Res Ctr, Eskilstuna, Sweden.(Swepub:uu)larra728
(författare)
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Smetana, J.Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.
(författare)
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Weckx, L.Univ Fed Sao Paulo, Ctr Referencia Imunobiol Especiais, Sao Paulo, Brazil.
(författare)
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Yeo, W.Univ Wollongong, Grad Sch Med, Illawarra Hlth & Med Res Inst, Wollongong, NSW, Australia.
(författare)
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Heineman, T. C.GSK Vaccines, King Of Prussia, PA USA.
(författare)
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Westmead Inst Med Res, Westmead, NSW, Australia.;Univ Sydney, Sydney, NSW, Australia.GSK Vaccines, King Of Prussia, PA USA.
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:New England Journal of Medicine375:11, s. 1019-10320028-47931533-4406
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Till lärosätets databas
- Av författaren/redakt...
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Cunningham, A. L ...
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Lal, H.
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Kovac, M.
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Chlibek, R.
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Hwang, S. -J
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Diez-Domingo, J.
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visa fler...
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Godeaux, O.
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Levin, M. J.
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McElhaney, J. E.
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Puig-Barbera, J.
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Abeele, C. Vande ...
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Vesikari, T.
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Watanabe, D.
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Zahaf, T.
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Ahonen, A.
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Athan, E.
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Barba-Gomez, J. ...
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Campora, L.
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de Looze, F.
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Downey, H. J.
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Ghesquiere, W.
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Gorfinkel, I.
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Korhonen, T.
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Leung, E.
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McNeil, S. A.
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Oostvogels, L.
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Rombo, Lars
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Smetana, J.
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Weckx, L.
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Yeo, W.
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Heineman, T. C.
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