{"id":4809,"date":"2025-08-12T10:24:37","date_gmt":"2025-08-12T10:24:37","guid":{"rendered":"https:\/\/www.dsru.org\/?post_type=abstract&#038;p=4809"},"modified":"2026-07-23T15:50:12","modified_gmt":"2026-07-23T15:50:12","slug":"abstract-262-passive-enhanced-safety-surveillance-in-children-receiving-fluenz-tetra-vaccination-in-england-during-the-early-2017-2018-influenza-season","status":"publish","type":"abstract","link":"https:\/\/www.dsru.org\/abstract\/abstract-262-passive-enhanced-safety-surveillance-in-children-receiving-fluenz-tetra-vaccination-in-england-during-the-early-2017-2018-influenza-season\/","title":{"rendered":"Abstract 262: Passive Enhanced Safety Surveillance In Children Receiving Fluenz\u00ae Tetra Vaccination In England During The Early 2017-2018 Influenza Season."},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Hazell1, S. Shakir* 1, J. Dentith2, E. Hammond3, D. Brooks3<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1Drug Safety Research Unit, Southampton, 2AstraZeneca, Luton, United Kingdom, 3AstraZeneca, Gaithersburg, United States<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Background<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Fluenz\u00ae Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children aged 2 to 17 years vaccinated as part of the seasonal influenza immunisation campaign in the UK.[1] Here, we present results from a third season of passive enhanced safety surveillance (ESS) for the vaccine in 2017-2018.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Objective<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">To measure and assess the frequencies of suspected adverse drug reactions (sADRs) in children receiving Fluenz\u00ae Tetra during the early 2017-2018 influenza season in England.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Methods<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Vaccinees or parents\/guardians received a Safety Report Card (SRC) to return if children experienced sADRs after vaccination with Fluenz\u00ae Tetra. At participating sites, 38 general practices and 36 primary schools in England, immunisation teams recorded numbers of SRCs distributed. The study was approved by an NHS Research Ethics Committee (Hampshire B South Central NRES Committee).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Results<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Between 29th September 2017 and 2nd December 2017, 12,193 children were vaccinated at study sites, with 16 different vaccine lots used. In total, 10,793 SRCs were issued for children aged 2 to 17 including 5,189 children (48.1%) aged 2 to 4 years, 5,036 (46.7%) aged 5 to 10 years and 568 (5.3%) aged 11 to 17 years. Of 114 SRCs returned (by 9th January 2018 datalock), 101 reported at least one sADR (0.9% of all SRCs issued). The most frequently reported sADRs were rhinorrhoea (n=36), pyrexia (31) and cough (14). Three reported sADRs were classified as serious due to hospitalisation (0.03% of all SRCs issued) including nasal symptoms, general cold\/flu symptoms and croup. The frequency of sADRs reported in the current ESS season was consistent with that reported in previous seasons.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Conclusion<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Overall, the number of sADRs reported for Fluenz\u00ae Tetra in the 2017-2018 ESS remains low. Reported sADRs were typically minor expected events with serious sADRs rarely reported. The pattern and frequency of reported sADRs in the 2017-2018 season were consistent with previous seasons with no safety signals detected. Despite the limited number of reports received, the ESS method continues to be a useful extension to routine pharmacovigilance activities in the monitoring of possible sADRs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Project sponsored by DSRU and AstraZeneca.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Reference<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">1. AstraZeneca. Fluenz\u00ae Tetra. Summary of Product Characteristics. Last updated: 22nd March 2018. Available at https:\/\/www.medicines.org.uk\/emc\/product\/3296\/smpc. Accessed: 9th May 2018<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"categories":[45],"tags":[],"class_list":["post-4809","abstract","type-abstract","status-publish","hentry","category-isop-18th-annual-meeting-geneva-november-2018"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Abstract 262: Fluenz Tetra Safety Surveillance 2017-18<\/title>\n<meta name=\"description\" content=\"DSRU abstract on passive enhanced safety surveillance of Fluenz Tetra influenza vaccine in children during the 2017-2018 season in England.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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