Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season
In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adv...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-08-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1705112 |
| _version_ | 1797677314950037504 |
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| author | Simon de Lusignan Silvia Damaso Filipa Ferreira Rachel Byford Christopher McGee Sameera Pathirannehelage Vishvesh Shende Ivelina Yonova Alexander Schmidt Anne Schuind Gael Dos Santos |
| author_facet | Simon de Lusignan Silvia Damaso Filipa Ferreira Rachel Byford Christopher McGee Sameera Pathirannehelage Vishvesh Shende Ivelina Yonova Alexander Schmidt Anne Schuind Gael Dos Santos |
| author_sort | Simon de Lusignan |
| collection | DOAJ |
| description | In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95–8.73] for events reported by card alone, and 9.21% [95% CI, 7.37–11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra. ClinicalTrials.gov number: NCT03278067 |
| first_indexed | 2024-03-11T22:43:19Z |
| format | Article |
| id | doaj.art-f3493645b6b64ea995dcb0dadd98b027 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:19Z |
| publishDate | 2020-08-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-f3493645b6b64ea995dcb0dadd98b0272023-09-22T08:45:35ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-08-011681762177110.1080/21645515.2019.17051121705112Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 seasonSimon de Lusignan0Silvia Damaso1Filipa Ferreira2Rachel Byford3Christopher McGee4Sameera Pathirannehelage5Vishvesh Shende6Ivelina Yonova7Alexander Schmidt8Anne Schuind9Gael Dos Santos10University of SurreyGSKUniversity of SurreyUniversity of SurreyUniversity of SurreyUniversity of SurreyVPN Consultancy Limited (on behalf of GSK)University of SurreyGSKGSKGSKIn compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95–8.73] for events reported by card alone, and 9.21% [95% CI, 7.37–11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra. ClinicalTrials.gov number: NCT03278067http://dx.doi.org/10.1080/21645515.2019.1705112safety managementmedical records systemsadverse reactionsinfluenza vaccinesgeneral practiceengland |
| spellingShingle | Simon de Lusignan Silvia Damaso Filipa Ferreira Rachel Byford Christopher McGee Sameera Pathirannehelage Vishvesh Shende Ivelina Yonova Alexander Schmidt Anne Schuind Gael Dos Santos Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season Human Vaccines & Immunotherapeutics safety management medical records systems adverse reactions influenza vaccines general practice england |
| title | Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season |
| title_full | Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season |
| title_fullStr | Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season |
| title_full_unstemmed | Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season |
| title_short | Brand-specific enhanced safety surveillance of GSK’s Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season |
| title_sort | brand specific enhanced safety surveillance of gsk s fluarix tetra seasonal influenza vaccine in england 2017 2018 season |
| topic | safety management medical records systems adverse reactions influenza vaccines general practice england |
| url | http://dx.doi.org/10.1080/21645515.2019.1705112 |
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