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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 06532naa a2200637 4500 | |
| 001 | oai:DiVA.org:uu-305455 | |
| 003 | SwePub | |
| 008 | 161018s2016 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3054552 URI |
| 024 | 7 | a https://doi.org/10.1056/NEJMoa16038002 DOI |
| 040 | a (SwePub)uu | |
| 041 | a engb eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Cunningham, A. L.u Westmead Inst Med Res, Westmead, NSW, Australia.;Univ Sydney, Sydney, NSW, Australia.4 aut |
| 245 | 1 0 | a Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older |
| 264 | 1 | c 2016 |
| 338 | a print2 rdacarrier | |
| 520 | a 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.) | |
| 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 |
| 700 | 1 | a Lal, H.u GSK Vaccines, King Of Prussia, PA USA.4 aut |
| 700 | 1 | a Kovac, M.u GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a Chlibek, R.u Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.4 aut |
| 700 | 1 | a Hwang, S. -J4 aut |
| 700 | 1 | a Diez-Domingo, J.u Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.4 aut |
| 700 | 1 | a Godeaux, O.u GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a Levin, M. J.u Univ Colorado, Dept Pediat, Anschutz Med Campus, Aurora, CO USA.;Univ Colorado, Dept Med, Anschutz Med Campus, Aurora, CO USA.4 aut |
| 700 | 1 | a McElhaney, J. E.u Hlth Sci North Res Inst, Sudbury, ON, Canada.4 aut |
| 700 | 1 | a Puig-Barbera, J.u Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain.4 aut |
| 700 | 1 | a Abeele, C. Vandenu GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a Vesikari, T.u Univ Tampere, Vaccine Res Ctr, Tampere, Finland.4 aut |
| 700 | 1 | a Watanabe, D.u Aichi Med Univ, Dept Dermatol, Nagakute, Aichi, Japan.4 aut |
| 700 | 1 | a Zahaf, T.u GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a Ahonen, A.u Univ Tampere, Vaccine Res Ctr, Tampere, Finland.4 aut |
| 700 | 1 | a Athan, E.u Deakin Univ, Barwon Hlth, Dept Infect Dis, Geelong, Vic, Australia.4 aut |
| 700 | 1 | a Barba-Gomez, J. F.u Inst Dermatol Jalisco Dr Jose Barba Rubio, Zapopan, Mexico.4 aut |
| 700 | 1 | a Campora, L.u GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a de Looze, F.u Univ Queensland, Sch Med, AusTrials, Brisbane, Qld, Australia.;Univ Queensland, Sch Med, Discipline Gen Practice, Brisbane, Qld, Australia.4 aut |
| 700 | 1 | a Downey, H. J.u Jacksonville Ctr Clin Res, Jacksonville, FL USA.4 aut |
| 700 | 1 | a Ghesquiere, W.u Univ British Columbia, Infect Dis Sect, Victoria, BC, Canada.4 aut |
| 700 | 1 | a Gorfinkel, I.u PrimeHlth Clin Res, Toronto, ON, Canada.4 aut |
| 700 | 1 | a Korhonen, T.u Univ Tampere, Vaccine Res Ctr, Tampere, Finland.4 aut |
| 700 | 1 | a Leung, E.u United Christian Hosp, Dept Med & Geriatr, Div Geriatr Med, Hong Kong, Hong Kong, Peoples R China.4 aut |
| 700 | 1 | a McNeil, S. A.u Dalhousie Univ, IWK Hlth Ctr, Canadian Ctr Vaccinol, Halifax, NS, Canada.;Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada.4 aut |
| 700 | 1 | a Oostvogels, L.u GSK Vaccines, Wavre, Belgium.4 aut |
| 700 | 1 | a Rombo, Larsu Uppsala universitet,Medicinska fakulteten,Centrum för klinisk forskning i Sörmland (CKFD),Sormland Cty Council, Clin Res Ctr, Eskilstuna, Sweden.4 aut0 (Swepub:uu)larra728 |
| 700 | 1 | a Smetana, J.u Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic.4 aut |
| 700 | 1 | a Weckx, L.u Univ Fed Sao Paulo, Ctr Referencia Imunobiol Especiais, Sao Paulo, Brazil.4 aut |
| 700 | 1 | a Yeo, W.u Univ Wollongong, Grad Sch Med, Illawarra Hlth & Med Res Inst, Wollongong, NSW, Australia.4 aut |
| 700 | 1 | a Heineman, T. C.u GSK Vaccines, King Of Prussia, PA USA.4 aut |
| 710 | 2 | a Westmead Inst Med Res, Westmead, NSW, Australia.;Univ Sydney, Sydney, NSW, Australia.b GSK Vaccines, King Of Prussia, PA USA.4 org |
| 773 | 0 | t New England Journal of Medicineg 375:11, s. 1019-1032q 375:11<1019-1032x 0028-4793x 1533-4406 |
| 856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-305455 |
| 856 | 4 8 | u https://doi.org/10.1056/NEJMoa1603800 |
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- Leung, E.
- McNeil, S. A.
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