1887
  1. Home
  2. Eurosurveillance
  3. Volume 21, Issue 14, 07/Apr/2016
  4. Article
Research article Open Access
Like 0
Download

Abstract

Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11–14 year-old vaccinees with AEFIs, using the number of qHPV doses distributed within the school-based vaccination programme as the denominator. Between September 2009 and August 2013, 211 AEFIs that occurred in 89 vaccinees were reported, a rate of 149.5 vaccinees with AEFI per 100,000 qHPV doses distributed. For five vaccinees, serious AEFIs (8.4 per 100,000 doses distributed) were reported. The highest reporting rates were for fatigue, headache, and fever (≥ 38.0⁰) (53.8, 40.3, and 35.3 per 100,000 qHPV doses distributed, respectively). As no AEFI resulted in permanent sequelae and they all were categorised as serious only due to the criterion of a minimum of one day of hospitalisation, this provides reassurance for the safety of our school-based HPV vaccination programme. Further AEFI surveillance is warranted to provide data for HPV vaccination programme monitoring and evaluation of its safety.

© Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2016.21.14.30187
2016-04-07
2025-07-02
/content/10.2807/1560-7917.ES.2016.21.14.30187
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/21/14/eurosurv-21-30187-2.html?itemId=/content/10.2807/1560-7917.ES.2016.21.14.30187&mimeType=html&fmt=ahah

References

  1. European Medicines Agency (EMA). European public assessment report (EPAR) for Gardasil. Summary of product characteristics. Updated 9 Mar 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000703/WC500021142.pdf
  2. European Medicines Agency (EMA). European public assessment report (EPAR) for Cervarix. Summary of product characteristics. Updated 2 Dec 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000721/WC500024632.pdf
  3. Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, et al. Centers for Disease Control and Prevention (CDC). Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015;64(11):300-4. PMID: 25811679 
  4. Labadie J. Postlicensure safety evaluation of human papilloma virus vaccines. Int J Risk Saf Med. 2011;23(2):103-12. PMID: 21673418 
  5. European Centre for Disease Control and Prevention (ECDC). Vaccine Schedule. [Accessed 5 Dec 2015]. Available from: http://vaccine-schedule.ecdc.europa.eu/Pages/Scheduler.aspx
  6. Lu B, Kumar A, Castellsagué X, Giuliano AR. Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review & meta-analysis. BMC Infect Dis. 2011;11(1):13.  https://doi.org/10.1186/1471-2334-11-13  PMID: 21226933 
  7. van Klooster TM, Kemmeren JM, van der Maas NA, de Melker HE. Reported adverse events in girls aged 13-16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands. Vaccine. 2011;29(28):4601-7.  https://doi.org/10.1016/j.vaccine.2011.04.050  PMID: 21549785 
  8. Gonçalves AK, Cobucci RN, Rodrigues HM, de Melo AG, Giraldo PC. Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review. Braz J Infect Dis. 2014;18(6):651-9.  https://doi.org/10.1016/j.bjid.2014.02.005  PMID: 24780368 
  9. Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008;18(5):1013-9.  https://doi.org/10.1111/j.1525-1438.2007.01123.x  PMID: 17986242 
  10. Bhatla N, Suri V, Basu P, Shastri S, Datta SK, Bi D, et al. Indian HPV Vaccine Study Group. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women. J Obstet Gynaecol Res. 2010;36(1):123-32.  https://doi.org/10.1111/j.1447-0756.2009.01167.x  PMID: 20178538 
  11. Khatun S, Akram Hussain SM, Chowdhury S, Ferdous J, Hossain F, Begum SR, et al. Safety and immunogenicity profile of human papillomavirus-16/18 AS04 adjuvant cervical cancer vaccine: a randomized controlled trial in healthy adolescent girls of Bangladesh. Jpn J Clin Oncol. 2012;42(1):36-41.  https://doi.org/10.1093/jjco/hyr173  PMID: 22194637 
  12. Block SL, Brown DR, Chatterjee A, Gold MA, Sings HL, Meibohm A, et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. Pediatr Infect Dis J. 2010;29(2):95-101.  https://doi.org/10.1097/INF.0b013e3181b77906  PMID: 19952863 
  13. 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 Oct 9;347:f5906. https://doi.org/10.1136/bmj.f5906  PMID: 24108159 
  14. Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279-84.  https://doi.org/10.1016/j.vaccine.2011.08.106  PMID: 21907257 
  15. Constantine NA, Jerman P. Acceptance of human papillomavirus vaccination among Californian parents of daughters: a representative statewide analysis. J Adolesc Health. 2007;40(2):108-15.  https://doi.org/10.1016/j.jadohealth.2006.10.007  PMID: 17259050 
  16. World Health Organization (WHO). Causality assessment of an adverse event following immunization (AEFI). User manual for the revised WHO classification. Geneva: WHO; 2013. Available from: http://www.who.int/vaccine_safety/publications/aevi_manual.pdf
  17. Medical Dictionary for Regulatory Activities (MedDRA). Introductory Guide MedDRA Version 17.0. March 2014. Available from: http://www.meddra.org/sites/default/files/guidance/file/intguide_17_0_english.pdf
  18. Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193-203.  https://doi.org/10.1111/j.1365-2796.2011.02467.x  PMID: 21973261 
  19. Chao C, Jacobsen SJ. Evaluation of autoimmune safety signal in observational vaccine safety studies. Hum Vaccin Immunother. 2012;8(9):1302-4.  https://doi.org/10.4161/hv.21268  PMID: 22871958 
  20. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750-7.  https://doi.org/10.1001/jama.2009.1201  PMID: 19690307 
  21. Harris T, Williams DM, Fediurek J, Scott T, Deeks SL. Adverse events following immunization in Ontario’s female school-based HPV program. Vaccine. 2014;32(9):1061-6.  https://doi.org/10.1016/j.vaccine.2014.01.004  PMID: 24440208 
  22. Rodríguez-Galán MA, Pérez-Vilar S, Díez-Domingo J, Tuells J, Gomar-Fayos J, Morales-Olivas F, et al. [Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)]. An Pediatr (Barc). 2014;81(5):303-9. Spanish.  PMID: 24582127 
  23. McKeon A, Vaughan C, Delanty N. Seizure versus syncope. Lancet Neurol. 2006;5(2):171-80.  https://doi.org/10.1016/S1474-4422(06)70350-7  PMID: 16426993 
  24. Naleway AL, Gold R, Drew L, Riedlinger K, Henninger ML, Gee J. Reported adverse events in young women following quadrivalent human papillomavirus vaccination. J Womens Health (Larchmt). 2012;21(4):425-32.  https://doi.org/10.1089/jwh.2011.2895  PMID: 22229713 
  25. Crawford NW, Clothier HJ, Elia S, Lazzaro T, Royle J, Buttery JP. Syncope and seizures following human papillomavirus vaccination: a retrospective case series. Med J Aust. 2011;194(1):16-8. PMID: 21449862 
  26. Kroger AT, Sumaya CV, Pickering LK, Atkinson WLNational Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(2):1-64. PMID: 21293327 
  27. Agorastos T, Chatzigeorgiou K, Brotherton JM, Garland SM. Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Vaccine. 2009;27(52):7270-81.  https://doi.org/10.1016/j.vaccine.2009.09.097  PMID: 19799849 
  28. Macartney KK, Chiu C, Georgousakis M, Brotherton JM. Safety of human papillomavirus vaccines: a review. Drug Saf. 2013;36(6):393-412.  https://doi.org/10.1007/s40264-013-0039-5  PMID: 23637071 
  29. Baxter R, Toback SL, Sifakis F, Hansen J, Bartlett J, Aukes L, et al. A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in adults 18-49 years of age. Vaccine. 2012;30(20):3053-60.  https://doi.org/10.1016/j.vaccine.2012.02.080  PMID: 22425787 
  30. Siegrist CA, Lewis EM, Eskola J, Evans SJ, Black SB. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infect Dis J. 2007;26(11):979-84.  https://doi.org/10.1097/INF.0b013e318149dfea  PMID: 17984802 
  31. Netterlid E, Månsson ME, Håkansson A. Surveillance of vaccine safety: comparison of parental reports with routine surveillance and a clinical trial. Vaccine. 2009;27(14):2042-7.  https://doi.org/10.1016/j.vaccine.2009.01.131  PMID: 19428828 
  32. France EK, Glanz J, Xu S, Hambidge S, Yamasaki K, Black SB, et al. Risk of immune thrombocytopenic purpura after measles–mumps–rubella immunization in children. Pediatrics. 2008 Mar;121(3):e687-92. PMID: 18310189 
Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Maja+%C5%A0ubelj&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Šubelj Maja</a>, <a href="/search?value1=Veronika+U%C4%8Dakar&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Učakar Veronika</a>, <a href="/search?value1=Alenka+Kraigher&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kraigher Alenka</a>, <a href="/search?value1=Irena+Klavs&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Klavs Irena</a></span>. Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013. <a href="/content/ecdc">Euro Surveill.</a> 2016;21(14):pii=30187. <a href="https://doi.org/10.2807/1560-7917.ES.2016.21.14.30187" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2016.21.14.30187</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 04 Apr 2015;&nbsp;&nbsp; <span class="generated">Accepted</span>: 04 Aug 2015 </span> </p>
/content/10.2807/1560-7917.ES.2016.21.14.30187
/content/10.2807/1560-7917.ES.2016.21.14.30187
Loading

Data & Media loading...

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error