Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season

Simon de Lusignan, Silvia Damaso, Filipa Ferreira, Rachel Byford, Christopher McGee, Sameera Pathirannehelage, Vishvesh Shende, Ivelina Yonova, Alexander Schmidt, Anne Schuind, Gael Dos Santos, Simon de Lusignan, Silvia Damaso, Filipa Ferreira, Rachel Byford, Christopher McGee, Sameera Pathirannehelage, Vishvesh Shende, Ivelina Yonova, Alexander Schmidt, Anne Schuind, Gael Dos Santos

Abstract

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.

Keywords: England; Safety management; adverse reactions; general practice; influenza vaccines; medical records systems.

Figures

Figure 1.
Figure 1.
(a) cumulative vaccinated cohort (any vaccine) of total eligible population, and number (%) of fluarix tetra recipients by (b) age and (c) UK CMO-specified risk group.
Figure 2.
Figure 2.
Cumulative AEI incidence rate (%) by study week, reported by AERC and EHR data combined for fluarix tetra, with 95% CI a, stratified by subject UK CMO risk status.

References

    1. World Health Organisation (WHO) . Influenza - burden of disease. [Accessed 2018 July]. .
    1. European Centre for Disease Prevention and Control (ECDC) . Factsheet about seasonal influenza. [Accessed 2018 July]. .
    1. World Health Organisation (WHO) . Influenza - WHO recommendations on the composition of influenza virus vaccines. [Accessed 2018 July]. .
    1. Knight M, Brocklehurst P, O’Brien P, Quigley MA, Kurinczuk JJ.. Planning for a cohort study to investigate the impact and management of influenza in pregnancy in a future pandemic. Southampton (UK): NIHR Journals Library; 2015. doi:10.3310/hsdr03060.
    1. Yates L, Pierce M, Stephens S, Mill AC, Spark P, Kurinczuk JJ, Valappil M, Brocklehurst P, Thomas SH, Knight M. Influenza A/H1N1v in pregnancy: an investigation of the characteristics and management of affected women and the relationship to pregnancy outcomes for mother and infant. Health Technol Assess. 2010;14(34):109–82. doi:10.3310/hta14340-02.
    1. National Health Service (NHS) . The national flu immunisation programme 2017/18; 2017. [Accessed 2018 November]. .
    1. Pebody RG, Sinnathamby MA, Warburton F, Andrews N, Boddington NL, Zhao H, Yonova I, Ellis J, Tessier E, Donati M, et al. Uptake and impact of vaccinating primary school-age children against influenza: experiences of a live attenuated influenza vaccine programme, England, 2015/16. Euro Surveill. 2018;23:25. doi:10.2807/1560-7917.ES.2018.23.25.1700496.
    1. European Medicines Agency (EMA) . Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU 2014. [Accessed 2018 July]. .
    1. European Medicines Agency (EMA) . Guideline on influenza vaccines - non-clinical and clinical module; 2016. [Accessed 2018 July]. .
    1. Electronic Medicines Compendium . Fluarix tetra (GSK) - summary product characteristics; 2018. [Accessed 2018 July]. .
    1. de Lusignan S, Dos Santos G, Correa A, Haguinet F, Yonova I, Lair F, Byford R, Ferreira F, Stuttard K, Chan T. Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England. BMJ Open. 2017;7(5):e015469. doi:10.1136/bmjopen-2016-015469.
    1. de Lusignan S, Ferreira F, Damaso S, Byford R, Pathirannehelage S, Yeakey A, Yonova I, Schuind A, Dos Santos G. Enhanced passive surveillance of influenza vaccination in England, 2016–2017- an observational study using an adverse events reporting card. Hum Vaccine Immunother. 2019;15(5):1048–59. doi:10.1080/21645515.2019.1565258.
    1. GlaxoSmithKline (GSK) . European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine; 2015. [Accessed 2019 January]. .
    1. Correa A, Hinton W, McGovern A, van Vlymen J, Yonova I, Jones S, de Lusignan S. Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) sentinel network: a cohort profile. BMJ Open. 2016;6(4):e011092. doi:10.1136/bmjopen-2016-011092.
    1. de Lusignan S, Correa A, Smith GE, Yonova I, Pebody R, Ferreira F, Elliot AJ, Fleming D. RCGP research and surveillance centre: 50 years’ surveillance of influenza, infections, and respiratory conditions. Br J Gen Pract. 2017;67(663):440–41. doi:10.3399/bjgp17X692645.
    1. Public Health England (PHE) . The green book - immunisation against infectious disease; 2013. [Accessed 2018 July]. .
    1. Department for Communities and Local Government . The english indices of deprivation; 2015. [Accessed 2018 July]. .
    1. Jordan H, Roderick P, Martin D. The index of multiple deprivation 2000 and accessibility effects on health. J Epidemiol Community Health. 2004;58(3):250–57. doi:10.1136/jech.2003.013011.
    1. . Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: pilot study in England; 2019. [Accessed 2019 September]. .
    1. GlaxoSmithKline (GSK) . Study register - study 207781 description; 2019. [Accessed 2019 September]. .
    1. Korn EL, Graubard BI. Confidence intervals for proportions with very small expected number of positive counts estimated from survey data. Surv Methodol. 1998;24:193–201. doi:12-001-X19980024356.
    1. National Health Service (NHS) . Defining research - NRES guidance to help you decide if your project requires review by a research ethics committee; 2013. [Accessed 2018 July]. .
    1. Routledge PA, O’Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol. 2004;57(2):121–26. doi:10.1046/j.1365-2125.2003.01875.x.
    1. Bricout H, Chabanon AL, Souverain A, Sadorge C, Vesikari T, Caroe TD. Passive enhanced safety surveillance for vaxigrip and intanza 15 microg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16. Euro Surveill. 2017;22:18. doi:10.2807/1560-7917.ES.2017.22.18.30527.
    1. de Lusignan S, Correa A, Ellis J, Pebody R. Influenza vaccination: in the UK and across Europe. Br J Gen Pract. 2016;66(650):452–53. doi:10.3399/bjgp16X686677.
    1. Dos Santos G, Yeakey A, Shende V, Smith K, Lin F, Zandman-van-Dijk E, Damaso S, Schmidt A. Passive enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain, an observational study: protocol for the 2018/2019 influenza season. BMJ Open. 2019;9(8):e028043. doi:10.1136/bmjopen-2018-028043.
    1. Dos Santos G. Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives. Hum Vaccin Immunother. 2019;15(11):2624–2636. doi:10.1080/21645515.2019.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera