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Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season
INTRODUCTION: Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains. OBJECTIVE: To comply with European Medicines Agency (EMA) guidance, an enhanced safety stud...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048703/ https://www.ncbi.nlm.nih.gov/pubmed/31884676 http://dx.doi.org/10.1007/s40264-019-00893-4 |
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author | Dos Santos, Gael Nguyen, Bach-Yen Damaso, Silvia Godderis, Lode Martínez-Gómez, Xavier Eckermann, Tamara Loos, Hugo Salamanca de la Cueva, Ignacio Shende, Vishvesh Schmidt, Alexander C. Yeakey, Anne |
author_facet | Dos Santos, Gael Nguyen, Bach-Yen Damaso, Silvia Godderis, Lode Martínez-Gómez, Xavier Eckermann, Tamara Loos, Hugo Salamanca de la Cueva, Ignacio Shende, Vishvesh Schmidt, Alexander C. Yeakey, Anne |
author_sort | Dos Santos, Gael |
collection | PubMed |
description | INTRODUCTION: Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains. OBJECTIVE: To comply with European Medicines Agency (EMA) guidance, an enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) within 7 days following vaccination with GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) in 2018/2019. METHODS: A customised AE reporting card (AERC) and standardised electronic data reporting application were used in Belgium, Germany and Spain in adult and paediatric subjects in this study. RESULTS: In 2018, 1060 subjects vaccinated with one dose of GSK’s IIV4 were enrolled (all subjects in Belgium and Germany were adults, and 75% and 25% of subjects in Spain were children and adults, respectively). In Spain, 139 eligible children later received a second dose. Overall 1035 subjects completed the study. After dose 1 and dose 2, 98.3% and 100% of subjects, respectively, returned the completed AERC. Over the study period, 43.0% (456/1060 post dose 1) and 23.7% (33/139 post dose 2) of subjects reported at least one AE within 7 days after immunisation. The most frequently reported categories of AEs were General and Administration Site (e.g. injection site pain, swelling, erythema) and Respiratory Disorders (e.g. rhinorrhoea, cough, nasal congestion). There were no deaths and no serious AEs deemed related to GSK’s IIV4. CONCLUSION: In compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK’s IIV4. CLINICALTRIALS.GOV IDENTIFIER: NCT03688620. |
format | Online Article Text |
id | pubmed-7048703 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-70487032020-03-13 Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season Dos Santos, Gael Nguyen, Bach-Yen Damaso, Silvia Godderis, Lode Martínez-Gómez, Xavier Eckermann, Tamara Loos, Hugo Salamanca de la Cueva, Ignacio Shende, Vishvesh Schmidt, Alexander C. Yeakey, Anne Drug Saf Original Research Article INTRODUCTION: Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains. OBJECTIVE: To comply with European Medicines Agency (EMA) guidance, an enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) within 7 days following vaccination with GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) in 2018/2019. METHODS: A customised AE reporting card (AERC) and standardised electronic data reporting application were used in Belgium, Germany and Spain in adult and paediatric subjects in this study. RESULTS: In 2018, 1060 subjects vaccinated with one dose of GSK’s IIV4 were enrolled (all subjects in Belgium and Germany were adults, and 75% and 25% of subjects in Spain were children and adults, respectively). In Spain, 139 eligible children later received a second dose. Overall 1035 subjects completed the study. After dose 1 and dose 2, 98.3% and 100% of subjects, respectively, returned the completed AERC. Over the study period, 43.0% (456/1060 post dose 1) and 23.7% (33/139 post dose 2) of subjects reported at least one AE within 7 days after immunisation. The most frequently reported categories of AEs were General and Administration Site (e.g. injection site pain, swelling, erythema) and Respiratory Disorders (e.g. rhinorrhoea, cough, nasal congestion). There were no deaths and no serious AEs deemed related to GSK’s IIV4. CONCLUSION: In compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK’s IIV4. CLINICALTRIALS.GOV IDENTIFIER: NCT03688620. Springer International Publishing 2019-12-28 2020 /pmc/articles/PMC7048703/ /pubmed/31884676 http://dx.doi.org/10.1007/s40264-019-00893-4 Text en © The Author(s) 2019 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Original Research Article Dos Santos, Gael Nguyen, Bach-Yen Damaso, Silvia Godderis, Lode Martínez-Gómez, Xavier Eckermann, Tamara Loos, Hugo Salamanca de la Cueva, Ignacio Shende, Vishvesh Schmidt, Alexander C. Yeakey, Anne Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title | Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title_full | Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title_fullStr | Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title_full_unstemmed | Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title_short | Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season |
title_sort | brand-specific enhanced safety surveillance of gsk’s quadrivalent seasonal influenza vaccine in belgium, germany and spain for the 2018/2019 season |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048703/ https://www.ncbi.nlm.nih.gov/pubmed/31884676 http://dx.doi.org/10.1007/s40264-019-00893-4 |
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