1. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients
- Author
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Dominicus Rolf, Ferrera Giuseppe, Freire Antônio Tarcísio, Lachance Pierre, Patrick Janice, Céline Boutry, Rodríguez de la Pinta Maria Luisa, Schaefer Axel, Hui David Shu Cheong, Schmidt Juergen, Plassmann Georg, Looze de Ferdinandus, Schenkenberger Isabelle, Josephine Ocran-Appiah, Toursarkissian Nicole, Grosskopf Josef, Beytout Jean, Staniscia Tommaso, Zahharova Irina, Klaff Leslie, Wachter Juergen, Kim Hyo Youl, Mueller Michael, Eto Takashi, Barbanti Piero, Lipetz Robert, Virta Miia, Ahonen Anitta, Ogata Hiroaki, Pauksens Karlis, McNally Damien, Grigat Christine, Geller Steven, Bengtsson Niklas, Poder Airi, Wilson Jonathan, Houser Patricia, Hwang Shinn-Jang, Berglund Johan Sanmartin, Jung Thomas, Rombo Lars, Datta Susan, Chlibeck Roman, Schubert Christian, Athan Eugene, Desole Maria Giuseppina, Huong Yieng, Dionne Marc, Stockhausen Juergen, Houle Pierre-Alain, Yunes Elsa Maria, Anne Schuind, Eckermann Tamara, Sueki Hirohiko, Schwarz Tino, Núñez López Concepción, Åke Olsson, Yeo Wilfred, Powell Calvin, Hartley Paul, Gerlach Beatrice, Curiac Dan, Hoeltz-Roehrig Susanne, Suzuki Shin, Mascareñas de Los Santos Abiel, Finneran Matthew, Ellison William, Narejos Pérez Silvia, Caroline Hervé, Pérez Vera Mercè, Powell Stephanie, Berndtsson Blom Katarina, Irimajiri Junya, Aldea Novo Marta, Dahmen Antje, Jacob Wilson, Kuroki Rie, Eizenberg Peter, Seppa Ilkka, Goldani Luciano, McNeil Shelly, Scott John, Liu Bo, Downey Herman Jackson, Andrews Charles, Caso Covadonga, Cunningham Anthony L, Toma Azhar, Lee Jacob, Ferguson Murdo, Weckx Lily, Berger-Roscher Juergen, Sauter Joachim, Park Dae Won, Forsten Aino, Barba-Gómez Jose-Fernando, Migliorino Guglielmo, Horacek Thomas, Levin Michael, Rosen Robert, Brotons Cuixart Carles, Koskinen Pekka, Schmitt Bernhard, Linnhoff Anneliese, Koenig Hans-Joachim, Tinoco Juan Carlos, Ghesquiere Wayne, Song Young Goo, Gauthier Jean-Sebastien, Icardi Giancarlo, Kokko Satu, Sha Edmund Kwok Yiu, Nakamura Kenjiro, Diez-Domingo Javier, Choo Eun-Ju, Lundvall Martin, Munir Abul Kashem, Jyoti Soni, Esen Meral, Arya Mark, Moeckesch Beate, Heaton Ken, Malempati Srikanth, Ervin John, Naritomi Yuji, Gorfinkel Iris, Manning Mary Beth, Tellier Guy, Poling Terry, and Lee Jin-Soo
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Vaccine safety ,Adult ,medicine.medical_specialty ,Herpesvirus 3, Human ,030231 tropical medicine ,Disease ,Placebo ,Herpes Zoster ,03 medical and health sciences ,0302 clinical medicine ,Open label study ,Adjuvants, Immunologic ,Internal medicine ,medicine ,Herpes Zoster Vaccine ,Humans ,030212 general & internal medicine ,Adverse effect ,Vaccines, Synthetic ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Incidence (epidemiology) ,Public Health, Environmental and Occupational Health ,Middle Aged ,Vaccination ,Infectious Diseases ,Molecular Medicine ,Zoster vaccine ,business ,medicine.drug - Abstract
Background Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies. Methods Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination. Results Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced ≥ 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%). Conclusions Nature and incidence of AEs, SAEs, and pIMDs were as expected and in line with the parent studies.
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- 2020