ArticleDrug safety2021
Safety Profile of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season.
Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The trial behind it
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Who cites it
5 citing papers in PubMed, 7 citations in OpenAlex.
- Post-Marketing Active Surveillance of Adverse Events Following Quadrivalent Subunit Influenza Vaccine in Healthy Participants Aged ≥ 3 Years in China.Infectious diseases and therapy · 2026Article
- Safety monitoring of GSK's quadrivalent seasonal influenza vaccine in European countries during the 2023/24 flu season: A multicenter, non-interventional study.Human vaccines & immunotherapeutics · 2025Observational
- Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season.Drug safety · 2024Article
- Observational
- Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine.Human vaccines & immunotherapeutics · 2023Article
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSeasonal influenza infects millions annually in Europe. Annual influenza vaccination is the most effective measure to reduce the risk of infection and its complications, especially among young children and older adults.
objectiveWe assessed adverse event (AE) frequency after receiving GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4).
methodsA passive enhanced safety surveillance study was conducted in Belgium, Germany, and Spain. Adults who had received GSK's IIV4 or the parent(s)/guardian(s)/legally acceptable representative(s) of children given the vaccine were invited to complete an adverse drug reaction (ADR) card to document AEs experienced within 7 days post vaccination.
resultsA total of 1082 participants (51.6% females) received GSK's IIV4, including 115 children < 9 years of age who received two doses. The ADR card return rate was 97.0% (n = 1049) after dose 1 and 100% (n = 115) after dose 2. All participants in Belgium and Germany were adults. In Spain, 71.2% were children. After dose 1, 39.2% reported one or more AE. The most frequent AEs category was "general disorders and administration site conditions" (GDASC). AEs were most frequently reported in adults aged 18-65 years (47.2%), followed by children aged 6 months-17 years (38.1%), and adults aged > 65 years (31.6%). After dose 2, 7.8% reported one or more AE, and GDASC was again the most frequent AE category. There were no serious AEs related to GSK's IIV4 within 7 days post vaccination.
conclusionNo serious AEs related to GSK's IIV4 within 7 days post vaccination were reported. This study supports the favourable risk-benefit safety profile of GSK's IIV4.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.