دورية أكاديمية
Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
| العنوان: | Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials |
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| المؤلفون: | Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, Zahaf, Toufik |
| بيانات النشر: | Uppsala universitet, Infektionssjukdomar Uppsala universitet, Centrum för klinisk forskning i Sörmland (CKFD) GSK, Ave Fleming 20, B-1300 Wavre, Belgium GSK, Rixensart, Belgium GSK, Ave Fleming 20, B-1300 Wavre, Belgium;CureVac AG, Tubingen, Germany AusTrials Pty Ltd, Sherwood, Qld, Australia;Univ Queensland, Sch Med, Brisbane, Qld, Australia Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain GSK, King Of Prussia, PA USA;Halozyme Therapeut, San Diego, CA USA GSK, King Of Prussia, PA USA;Pfizer Vaccine Inc, Collegeville, PA USA Hlth Sci North Res Inst, Sudbury, ON, Canada Univ Wollongong, Sch Med, Wollongong, NSW, Australia Univ Tampere, Jarvenpaa Vaccine Clin, Tampere, Finland Univ Sao Paulo, Sch Med, Sao Paulo, Brazil Inst Dermatol Jalisco, Guadalajara, Jalisco, Mexico Blekinge Inst Technol, Karlskrona, Sweden EAP Sardenya, Barcelona, Spain Hosp Clin San Carlos, Madrid, Spain Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic Korea Univ, Coll Med, Seoul, South Korea Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia Serv Igiene Pubbl, Sassari, Italy Doctors Ivanhoe, Ivanhoe, Australia Univ Clin Tubingen, Inst Tropenmed, Tubingen, Germany GSK, Brussels, Belgium Q&T Res Sherbrooke, Sherbrooke, PQ, Canada Univ British Columbia, Vancouver, BC, Canada York Univ, N York, ON, Canada Prince Wales Hosp, Hong Kong, Peoples R China Taipei Vet Gen Hosp, Taipei, Taiwan;Natl Yang Ming Univ, Sch Med, Taipei, Taiwan Univ Tampere, Sch Med, Vaccine Res Ctr, Tampere, Finland GSK, New York, NY USA Hong Kong Assoc Gerontol, Hong Kong, Peoples R China Univ Colorado, Anschutz Med Campus, Aurora, CO USA CAP Centelles, Centelles, Spain Inst AZ Pesquisa & Ensino, Curitiba, Parana, Brazil Kliiniliste Uuringute Keskus, Tartu, Estonia Hosp Puerta de Hierro, Madrid, Spain Standort Juliusspital, Wurzburg, Germany Univ G dAnnunzio, Chieti, Italy Hosp Gen Durango, Durango, Mexico Manna Res, Toronto, ON, Canada Univ Tampere, Tampere, Finland AO Univ Policlin Tor Vergata, Rome, Italy Kobe Univ, Grad Sch Med, Kobe, Hyogo, Japan Univ Fed Sao Paulo, Sao Paulo, Brazil ELSEVIER SCI LTD |
| سنة النشر: | 2019 |
| المجموعة: | Uppsala University: Publications (DiVA) |
| مصطلحات موضوعية: | Varicella-zoster virus, Vaccine, Safety, Reactogenicity, General Practice, Allmänmedicin |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | Vaccine, 0264-410X, 2019, 37:18, s. 2482-2493; http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-387212Test; PMID 30935742; ISI:000466622500009 |
| DOI: | 10.1016/j.vaccine.2019.03.043 |
| الإتاحة: | https://doi.org/10.1016/j.vaccine.2019.03.043Test http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-387212Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9F5CEE56 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.vaccine.2019.03.043 |
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