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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials
Vaccine, Volume 37, No. 18, Year 2019
Notification
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Description
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. © 2019 GlaxoSmithKline Biologicals SA
Authors & Co-Authors
Campora, Laura
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Oostvogels, Lidia C.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Díez Domingo, Javier
Spain, Valencia
Fundacion Para el Fomento de la Investigacion Sanitaria y Biomedica de la Comunitat Valenciana
McElhaney, Janet E.
Canada, Sudbury
Health Sciences North Research Institute
McNeil, Shelly Ann
Canada, Halifax
Iwk Health Centre
Tavares-Da-Silva, Fernanda
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Berglund, Johan Sanmartin
Sweden, Karlskrona
Blekinge Tekniska Högskola
Esen, Meral
Germany, Tubingen
Universitätsklinikum Und Medizinische Fakultät Tübingen
Espié, Emmanuelle
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Ghesquiere, Wayne
Canada, Vancouver
The University of British Columbia
Godeaux, Olivier O.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Hui, David Shu Cheong
Hong Kong
Prince of Wales Hospital Hong Kong
Hwang, Shinnjang
Taiwan, Taipei
Taipei Veterans General Hospital
Levin, Myron J.
United States, Aurora
University of Colorado Anschutz Medical Campus
Põder, Airi
Unknown Affiliation
Rombo, Lars
Sweden, Uppsala
Uppsala Universitet
Schwarz, Tino Francis
Unknown Affiliation
Staniscia, Tommaso
Italy, Chieti
University of G. D'annunzio Chieti and Pescara
Tinoco-Fávila, Juan Carlos
Unknown Affiliation
Vesikari, Timo H.
Finland, Tampere
Tampere University
Weckx, Lily Yin
Brazil, Sao Paulo
Universidade Federal de São Paulo
Zahaf, Toufik
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Statistics
Citations: 32
Authors: 22
Affiliations: 28
Identifiers
Doi:
10.1016/j.vaccine.2019.03.043
ISSN:
0264410X
Study Design
Cohort Study