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Abstract

Background and aim

In January 2013, a novel vaccine against serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. All adverse events following immunisation (AEFI) reported from Germany since the vaccine’s launch in Germany in November 2013 through December 2016 were reviewed and analysed. Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

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2018-04-26
2024-04-19
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2018.23.17.17-00468
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References

  1. European Centre for Disease Prevention and Control (ECDC). Annual epidemiological report for 2015. Invasive meningococcal disease. Stockholm: ECDC; 2017. Available from: https://ecdc.europa.eu/sites/portal/files/documents/AER_for_2015-meningococcal-disease.pdf
  2. Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis. 2010;50(s2) Suppl 2;S54-65.  https://doi.org/10.1086/648966  PMID: 20144017 
  3. Harrison LH. Vaccines for prevention of group B meningococcal disease: Not your father’s vaccines. Vaccine. 2015;33(Suppl 4):D32-8.  https://doi.org/10.1016/j.vaccine.2015.05.101  PMID: 26116255 
  4. Gorringe AR, Pajón R. Bexsero: a multicomponent vaccine for prevention of meningococcal disease. Hum Vaccin Immunother. 2012;8(2):174-83.  https://doi.org/10.4161/hv.18500  PMID: 22426368 
  5. Infektionsschutzgesetz (IfSG). [Protection against Infection Act]. 1 Jan 2001. German. Available from: http://www.gesetze-im-internet.de/ifsg/index.html
  6. Medicinal Products Act (Arzneimittelgesetz – AMG). 24 Aug 1976. Available from: https://www.gesetze-im-internet.de/englisch_amg/index.html
  7. European Medicines Agency (EMA). ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. CPMP/ICH/377/95. London: EMA; 1995. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002749.pdf
  8. Introductory Guide. MedDRA Version 20.1. McLean, Virginia: Medical Dictionary for Regulatory Activities (MedDRA) Maintenance and Support Services Organization (MSSO); Sep 2017. [Accessed 19 Apr 2018]. Available from: https://www.meddra.org/sites/default/files/guidance/file/intguide_20_1_english_0.pdf
  9. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Expert Working Group. Clinical investigation of medicinal products in the pediatric population E11. Geneva: ICH; 20 Jul 2000. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf
  10. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10(6):483-6.  https://doi.org/10.1002/pds.677  PMID: 11828828 
  11. Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013;347(oct09 4):f5906.  https://doi.org/10.1136/bmj.f5906  PMID: 24108159 
  12. World Health Organization (WHO). Module 5: Vaccine safety institutions and mechanisms. Brighton Collaboration – setting standards in vaccine safety. Geneva: WHO. [Accessed 23 Apr 2018]. Available from: http://vaccine-safety-training.org/brighton-collaboration.html
  13. Causality assessment of an adverse event following immunization (AEFI). User manual for the revised WHO classification. Geneva: World Health Organization; 2013. Available from: http://www.who.int/vaccine_safety/publications/aevi_manual.pdf
  14. Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22(5-6):557-62.  https://doi.org/10.1016/j.vaccine.2003.09.008  PMID: 14741144 
  15. Rüggeberg JU, Gold MS, Bayas J-M, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-84.  https://doi.org/10.1016/j.vaccine.2007.02.064  PMID: 17448577 
  16. Buettcher M, Heininger U, Braun M, Bonhoeffer J, Halperin S, Heijbel H, et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2007;25(31):5875-81.  https://doi.org/10.1016/j.vaccine.2007.04.061  PMID: 17537554 
  17. Findlow J, Borrow R, Snape MD, Dawson T, Holland A, John TM, et al. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis. 2010;51(10):1127-37.  https://doi.org/10.1086/656741  PMID: 20954968 
  18. Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010;29(11):e71-9. PMID: 20844462 
  19. Gossger N, Snape MD, Yu L-M, Finn A, Bona G, Esposito S, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573-82.  https://doi.org/10.1001/jama.2012.85  PMID: 22318278 
  20. Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825-35.  https://doi.org/10.1016/S0140-6736(12)61961-8  PMID: 23324563 
  21. Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14.  https://doi.org/10.4161/hv.29218  PMID: 25424810 
  22. Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, et al. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015;33(29):3322-30.  https://doi.org/10.1016/j.vaccine.2015.05.027  PMID: 26025807 
  23. Lee HJ, Choe YJ, Hong Y-J, Kim K-H, Park SE, Kim Y-K, et al. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016;34(9):1180-6.  https://doi.org/10.1016/j.vaccine.2016.01.033  PMID: 26826544 
  24. Tenenbaum T, Niessen J, Schroten H. Severe Upper Extremity Dysfunction After 4CMenB Vaccination in a Young Infant. Pediatr Infect Dis J. 2016;35(1):94-6. PMID: 26379162 
  25. Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine administration (SIRVA). Vaccine. 2010;28(51):8049-52.  https://doi.org/10.1016/j.vaccine.2010.10.005  PMID: 20955829 
  26. Public Health England. Using paracetamol to prevent and treat fever after MenB vaccination. London: National Health Service; 2015. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/483408/9413-paracetamol-menB-2page-A4-08-web.pdf
  27. Nainani V, Galal U, Buttery J, Snape MD. An increase in accident and emergency presentations for adverse events following immunisation after introduction of the group B meningococcal vaccine: an observational study. Arch Dis Child. 2017;102(10):958-62.  https://doi.org/10.1136/archdischild-2017-312941  PMID: 28794096 
  28. Wilkins AL, Snape MD. Emerging clinical experience with vaccines against group B meningococcal disease. Vaccine. 2017. https://doi.org/10.1016/j.vaccine.2017.07.056 PMID: 28778616 
  29. Hertz CL, Christiansen SL, Larsen MK, Dahl M, Ferrero-Miliani L, Weeke PE, et al. Genetic investigations of sudden unexpected deaths in infancy using next-generation sequencing of 100 genes associated with cardiac diseases. Eur J Hum Genet. 2016;24(6):817-22.  https://doi.org/10.1038/ejhg.2015.198  PMID: 26350513 
  30. Sanchez O, Campuzano O, Fernández-Falgueras A, Sarquella-Brugada G, Cesar S, Mademont I, et al. Natural and Undetermined Sudden Death: Value of Post-Mortem Genetic Investigation. PLoS One. 2016;11(12):e0167358.  https://doi.org/10.1371/journal.pone.0167358  PMID: 27930701 
  31. Oshima Y, Yamamoto T, Ishikawa T, Mishima H, Matsusue A, Umehara T, et al. Postmortem genetic analysis of sudden unexpected death in infancy: neonatal genetic screening may enable the prevention of sudden infant death. J Hum Genet. 2017;62(11):989-95.  https://doi.org/10.1038/jhg.2017.79  PMID: 28747690 
  32. Winkel BG, Risgaard B, Sadjadieh G, Bundgaard H, Haunsø S, Tfelt-Hansen J. Sudden cardiac death in children (1-18 years): symptoms and causes of death in a nationwide setting. Eur Heart J. 2014;35(13):868-75.  https://doi.org/10.1093/eurheartj/eht509  PMID: 24344190 
  33. Risgaard B, Winkel BG, Jabbari R, Behr ER, Ingemann-Hansen O, Thomsen JL, et al. Burden of sudden cardiac death in persons aged 1 to 49 years: nationwide study in Denmark. Circ Arrhythm Electrophysiol. 2014;7(2):205-11.  https://doi.org/10.1161/CIRCEP.113.001421  PMID: 24604905 
Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Dirk+Mentzer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mentzer Dirk</a>, <a href="/search?value1=Doris+Oberle&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Oberle Doris</a>, <a href="/search?value1=Brigitte+Keller-Stanislawski&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Keller-Stanislawski Brigitte</a></span>. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016. <a href="/content/ecdc">Euro Surveill.</a> 2018;23(17):pii=17-00468. <a href="https://doi.org/10.2807/1560-7917.ES.2018.23.17.17-00468" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2018.23.17.17-00468</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 11 Jul 2017;&nbsp;&nbsp; <span class="generated">Accepted</span>: 05 Nov 2017 </span> </p>
/content/10.2807/1560-7917.ES.2018.23.17.17-00468
/content/10.2807/1560-7917.ES.2018.23.17.17-00468
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