Accès ouvert déclaré
2020
article
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
Josephine C Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni, Anne Schuind, Åke Olsson, Anitta Ahonen, Aldea Novo Marta, Andrews Charles, Mark Arya, Eugene Athan, Jose-Fernando Barba-Gómez, Piero Barbanti, Niklas Bengtsson, Juergen Berger-Roscher, Berglund Johan Sanmartin, Berndtsson Blom Katarina, Jean Beytout, B. Carles, Covadonga Caso, Chlibeck Roman, Choo Eun-Ju, Cunningham Anthony L, Dan Curiac, Antje Dahmen, Susan Datta, Looze de Ferdinandus, Desole Maria Giuseppina, Marc Dionne, R. Dominicus, Downey Herman Jackson, Tamara Eckermann, Peter Eizenberg, Ellison William, John Ervin, Meral Esen, Takashi Eto, Murdo Ferguson, Giuseppe Ferrera, Matthew Finneran, Aino Forstén, Freire Antônio Tarcísio, Jean-Sebastien Gauthier, G. Steven, Beatrice Gerlach, Goldani Luciano, Gorfinkel Iris, Christine Grigat, Josef Großkopf, Paul Hartley, Ken Heaton, Hoeltz-Roehrig Susanne, Thomas Horacek, Houle Pierre-Alain, Houser Patricia, Hui David Shu Cheong, Yieng Huong, Shinn‐Jang Hwang, Icardi Giancarlo, Junya Irimajiri, Jacob Wilson, Thomas Jung, Kim Hyo Youl, Klaff Leslie, Hans-Joachim Koenig, Satu Kokko, Pekka Koskinen, Rie Kuroki, Pierre Lachance, Jacob Lee, Lee Jin-Soo, Levin Michael, Anneliese Linnhoff, Robert Lipetz, Bo Liu, Martin Lundvall, Malempati Srikanth, Manning Mary Beth, Mascareñas de Los Santos Abiel, Damien McNally, McNeil Shelly, Guglielmo Migliorino, Beate Moeckesch, Michael Mueller, Munir Abul Kashem, Kenjiro Nakamura, Narejos Pérez Silvia, Yuji Naritomi, Núñez López Concepción, Ogata Hiroaki, Park Dae Won, Janice Patrick, Karlis Pauksens, Pérez Vera Mercè, Georg Plassmann, Airi Põder, Terry L. Poling, Powell Calvin, Powell Stephanie, Rodríguez de la Pinta Maria Luisa, Lars Rombo, Robert Rosen, Joachim Sauter, Axel Schaefer, Isabelle Schenkenberger, Schmidt Juergen, Bernhard Schmitt, Schubert Christian, Tino Schwarz, Scott John, Ilkka Seppä, Sha Edmund Kwok Yiu, Song Young Goo, Tommaso Staniscia, Stockhausen Juergen, Hirohiko Sueki, Suzuki Shin, Guy Tellier, Tinoco Juan Carlos, Azhar Toma, Nicole Toursarkissian, Miia Virta, Juergen Wachter, Weckx Lily, Jonathan Wilson, Wilfred Yeo, Yunes Elsa Maria, Irina Zahharova
16Citations signalées, ce qui n’est pas une note de qualité
4Institutions déclarées
3Pays d’affiliation déclarés
Rattachement africain : us, be, in.
Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 01/01/2021
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Les institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Les sujets associés
Herpesvirus Infections and TreatmentsFacial Nerve Paralysis Treatment and ResearchDermatology and Skin Diseases