Influenza vaccines: Evaluation of the safety profile

References

• Trombetta CM, Montomoli E. Influenza immunology evaluation and correlates of protection: a focus on vaccines. Expert Rev Vaccines. 2016;15(8):967–76. doi:10.1586/14760584.2016.1164046.
   PubMed Web of Science ®Google Scholar
• Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: recommendations of the advisory committee on immunization practices, United States, 2015–16. Influenza Season. Morb Mortal Wkly Rep (MMWR). 2005;64(30):818–825. CDC.
   Google Scholar
• Global Advisory Committee on Vaccine, S. and W.H.O. secretariat, Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS. Expert Rev Vaccines. 2009;8(6):705–16. doi:10.1586/erv.09.40.
   PubMed Web of Science ®Google Scholar
• Halsey NA. The science of evaluation of adverse events associated with vaccination. Semin Pediatr Infect Dis. 2002;13(3):205–14. doi:10.1053/spid.2002.125864.
   PubMedGoogle Scholar
• WHO. Casuality assessment of an adverse event following immunizaiton (AEFI). 2013;1–56. ISBN: 978 92 4 150533 8.
   Google Scholar
• CDC. Understanding the vaccine adverse event reporting system (VAERS). 2013.
   Google Scholar
• FDA, Guideline for Industry. Clinical safety data management: definitions and standards ofr expedited reporting. ICH-E2A. 1995;1–17.
   Google Scholar
• McPhillips H, Marcuse EK. Vaccine safety. Curr Probl Pediatr. 2001;31(4):91–121.
   PubMedGoogle Scholar
• Halsey NA, Talaat KR, Greenbaum A, Mensah E, Dudley MZ, Proveaux T, Salmon DA. The safety of influenza vaccines in children: An Institute for Vaccine Safety white paper. Vaccine. 2015;33(Suppl 5):F1–F67. doi:10.1016/j.vaccine.2015.10.080.
   PubMedGoogle Scholar
• Li R, Stewart B, McNeil MM, Duffy J, Nelson J, Kawai AT, Baxter R, Belongia EA, Weintraub E. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013–2014 and 2014–2015 seasons. Pharmacoepidemiol Drug Saf. 2016;25(8):928–34. doi:10.1002/pds.3996.
   PubMed Web of Science ®Google Scholar
• ECDC. Enhanced monitoring of vaccine safety for 2009 pandemic vaccines. 2013.
   Google Scholar
• Hanley JA, Lippman-Hand A, If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA. 1983;249(13):1743–5. doi:10.1001/jama.1983.03330370053031.
   PubMed Web of Science ®Google Scholar
• Sarkanen TO, Alakuijala APE, Dauvilliers YA, Partinen MM. Incidence of narcolepsy after H1N1 influenza and vaccinations: Systematic review and meta-analysis. Sleep Med Rev. 2017. pii: S1087-0792(17)30001-1. doi:10.1016/j.smrv.2017.06.006. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• European Medicine Agency (EMA). Guideline on influenza vaccines. Non-clinical and clinical module. EMA/CHMP/VWP/457259/2014. 2016.
   Google Scholar
• 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):1–9. doi:10.2807/1560-7917.ES.2017.22.18.30527.
   Google Scholar
• Moro PL, Li R, Haber P, Weintraub E, Cano M. Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention. Expert Opin Drug Saf. 2016;15(9):1175–83. doi:10.1080/14740338.2016.1194823.
   PubMed Web of Science ®Google Scholar
• Wijnans L, Voordouw B. A review of the changes to the licensing of influenza vaccines in Europe. Influenza Other Respir Viruses. 2016;10(1):2–8. doi:10.1111/irv.12351.
   PubMed Web of Science ®Google Scholar
• Huang YL, Moon J, Segal JB. A comparison of active adverse event surveillance systems worldwide. Drug Saf. 2014;37(8):581–96. doi:10.1007/s40264-014-0194-3.
   PubMed Web of Science ®Google Scholar
• Gianchecchi E, Trombetta CM, Piccirella S, Montomoli E. Evaluating influenza vaccines: progress and perspectives. Future Virology. 2016;11(5):379–93. doi:10.2217/fvl-2016-0012.
   Web of Science ®Google Scholar
• Sridhar S, Brokstad KA, Cox RJ. Influenza Vaccination Strategies: Comparing Inactivated and Live Attenuated Influenza Vaccines. Vaccines (Basel). 2015;3(2):373–89. doi:10.3390/vaccines3020373.
   PubMed Web of Science ®Google Scholar
• Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines. CPMP/BWP/214/96. 1997.
   Google Scholar
• Committee for Medicinal Products for Human Use (CHMP). Guideline on influenza vaccines. Non-clinical and Clinical module. EMA/CHMP/VWP/457259/2014. 2014.
   Google Scholar
• Hannoun C. The evolving history of influenza viruses and influenza vaccines. Expert Rev Vaccines. 2013;12(9):1085–94. doi:10.1586/14760584.2013.824709.
   PubMed Web of Science ®Google Scholar
• Muhammad R, Haber P, Broder K, Leroy Z, Ball R, Braun MM, Davis RL, McMahon AW. Adverse events following trivalent inactivated influenza vaccination in children: analysis of the vaccine adverse event reporting system. Pediatr Infect Dis J. 2011;30(1):e1–8. doi:10.1097/INF.0b013e3181ff9795.
   PubMed Web of Science ®Google Scholar
• Health D. Flu (influenza) vaccine and children: what WA parents need to know. Department of Health Western Australia. 2012. http://www.health.wa.gov.au/flu/families_individuals/children.cfm.
   Google Scholar
• Li-Kim-Moy J, Yin JK, Rashid H, Khandaker G, King C, Wood N, Macartney KK, Jones C, Booy R. Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children. Euro Surveill. 2015;20(24):1–10. doi:10.2807/1560-7917.ES2015.20.24.21159.
   PubMedGoogle Scholar
• Esposito S, Giavoli C, Trombetta C, Bianchini S, Montinaro V, Spada A, Montomoli E, Principi N, Immunogenicity, safety and tolerability of inactivated trivalent influenza vaccine in overweight and obese children. Vaccine. 2016;34(1):56–60. doi:10.1016/j.vaccine.2015.11.019.
   PubMed Web of Science ®Google Scholar
• Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother. 2012;8(1):81–8. doi:10.4161/hv.8.1.17623.
   PubMed Web of Science ®Google Scholar
• Soema PC, Kompier R, Amorij JP, Kersten GF. Current and next generation influenza vaccines: Formulation and production strategies. Eur J Pharm Biopharm. 2015;94:251–63. doi:10.1016/j.ejpb.2015.05.023.
   PubMed Web of Science ®Google Scholar
• CDC. Prevention and Control of Influenza with Vaccines: Interim Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2013. Morb Mortal Wkly Rep. (MMWR) 2013;62(18):356–356.
   Google Scholar
• Greenberg DP, Robertson CA, Noss MJ, Blatter MM, Biedenbender R, Decker MD. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. Vaccine. 2013;31(5):770–6. doi:10.1016/j.vaccine.2012.11.074.
   PubMed Web of Science ®Google Scholar
• Pepin S, Donazzolo Y, Jambrecina A, Salamand C, Saville M. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013;31(47):5572–8. doi:10.1016/j.vaccine.2013.08.069.
   PubMed Web of Science ®Google Scholar
• Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006;24(8):1159–69. doi:10.1016/j.vaccine.2005.08.105.
   PubMed Web of Science ®Google Scholar
• McElhaney JE, Zhou X, Talbot HK, Soethout E, Bleackley RC, Granville DJ, Pawelec G. The unmet need in the elderly: how immunosenescence, CMV infection, co-morbidities and frailty are a challenge for the development of more effective influenza vaccines. Vaccine. 2012;30(12):2060–7. doi:10.1016/j.vaccine.2012.01.015.
   PubMed Web of Science ®Google Scholar
• Beyer WEP, Palache AM, Boulfich M, Osterhaus A. Rationale for two influenza B lineages in seasonal vaccines: A meta-regression study on immunogenicity and controlled field trials. Vaccine. 2017;35(33):4167–4176. doi:10.1016/j.vaccine.2017.06.038.
   PubMed Web of Science ®Google Scholar
• Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >/ = 18 years: a phase III, randomized trial. Vaccine. 2014;32(13):1480–7. doi:10.1016/j.vaccine.2014.01.022.
   PubMed Web of Science ®Google Scholar
• Regan AK, Tracey L, Gibbs R. Post-marketing surveillance of adverse events following immunization with inactivated quadrivalent and trivalent influenza vaccine in health care providers in Western Australia. Vaccine. 2015;33(46):6149–51. doi:10.1016/j.vaccine.2015.10.005.
   PubMed Web of Science ®Google Scholar
• Moa AM, Chughtai AA, Muscatello DJ, Turner RM, MacIntyre CR. Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Vaccine. 2016;34(35):4092–102. doi:10.1016/j.vaccine.2016.06.064.
   PubMed Web of Science ®Google Scholar
• Rodriguez Weber MA, Claeys C, Aranza Doniz C, Feng Y, Innis BL, Jain VK, Peeters M. Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18–47 months of age. Pediatr Infect Dis J. 2014;33(12):1262–9. doi:10.1097/INF.0000000000000463.
   PubMed Web of Science ®Google Scholar
• Haber P, Moro PL, Lewis P, Woo EJ, Jankosky C, Cano M. Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015. Vaccine. 2016;34(22):2507–12. doi:10.1016/j.vaccine.2016.03.048.
   PubMed Web of Science ®Google Scholar
• Cox RJ. Correlates of protection to influenza virus, where do we go from here? Hum Vaccin Immunother. 2013;9(2):405–8. doi:10.4161/hv.22908.
   PubMed Web of Science ®Google Scholar
• Isakova-Sivak I, Rudenko L. Safety, immunogenicity and infectivity of new live attenuated influenza vaccines. Expert Rev Vaccines. 2015;14(10):1313–29. doi:10.1586/14760584.2015.1075883.
   PubMed Web of Science ®Google Scholar
• Ambrose CS, Luke C, Coelingh K. Current status of live attenuated influenza vaccine in the United States for seasonal and pandemic influenza. Influenza Other Respir Viruses. 2008;2(6):193–202. doi:10.1111/j.1750-2659.2008.00056.x.
   PubMed Web of Science ®Google Scholar
• WHO. Global pandemic influenza action plan to increase vaccine supply: progress report 2006–2008. WHO/IVB/09.05. 2009;1–69.
   Google Scholar
• Bergen R, Black S, Shinefield H, Lewis E, Ray P, Hansen J, Walker R, Hessel C, Cordova J, Mendelman PM. Safety of cold-adapted live attenuated influenza vaccine in a large cohort of children and adolescents. Pediatr Infect Dis J. 2004;23(2):138–44. doi:10.1097/01.inf.0000109392.96411.4f.
   PubMed Web of Science ®Google Scholar
• Ambrose CS, Yi T, Falloon J. An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2–17 years. Influenza Other Respir Viruses. 2011;5(6):389–97. doi:10.1111/j.1750-2659.2011.00243.x.
   PubMed Web of Science ®Google Scholar
• Esposito S, Montinaro V, Groppali E, Tenconi R, Semino M, Principi N. Live attenuated intranasal influenza vaccine. Hum Vaccin Immunother. 2012;8(1):76–80. doi:10.4161/hv.8.1.18809.
   PubMed Web of Science ®Google Scholar
• Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM, Group C-TCES. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007;356(7):685–96. doi:10.1056/NEJMoa065368.
   PubMed Web of Science ®Google Scholar
• Carter NJ, Curran MP. Live attenuated influenza vaccine (FluMist(R); Fluenz): a review of its use in the prevention of seasonal influenza in children and adults. Drugs. 2011;71(12):1591–622. doi:10.2165/11206860-000000000-00000.
   PubMed Web of Science ®Google Scholar
• Tennis P, Toback SL, Andrews E, McQuay LJ, Ambrose CS. A postmarketing evaluation of the frequency of use and safety of live attenuated influenza vaccine use in nonrecommended children younger than 5 years. Vaccine. 2011;29(31):4947–52. doi:10.1016/j.vaccine.2011.04.113.
   PubMed Web of Science ®Google Scholar
• Baxter R, Toback SL, Sifakis F, Hansen J, Bartlett J, Aukes L, Lewis N, Wu X, Ambrose CS. 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. doi:10.1016/j.vaccine.2012.02.080.
   PubMed Web of Science ®Google Scholar
• Kelso JM. Safety of influenza vaccines. Curr Opin Allergy Clin Immunol. 2012;12(4):383–8. doi:10.1097/ACI.0b013e328354395d.
   PubMed Web of Science ®Google Scholar
• Tennis P, Toback SL, Andrews EB, McQuay LJ, Ambrose CS. A US postmarketing evaluation of the frequency and safety of live attenuated influenza vaccine use in nonrecommended children younger than 5 years: 2009–2010 season. Vaccine. 2012;30(42):6099–102. doi:10.1016/j.vaccine.2012.07.031.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Karvonen A, Korhonen T, Edelman K, Vainionpaa R, Salmi A, Saville MK, Cho I, Razmpour A, Rappaport R, et al. A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine. Pediatr Infect Dis J. 2006;25(7):590–5. doi:10.1097/01.inf.0000220229.51531.47.
   PubMed Web of Science ®Google Scholar
• Belshe RB, Gruber WC, Mendelman PM, Mehta HB, Mahmood K, Reisinger K, Treanor J, Zangwill K, Hayden FG, Bernstein DI, et al. Correlates of immune protection induced by live, attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine. J Infect Dis. 2000;181(3):1133–7. doi:10.1086/315323.
   PubMed Web of Science ®Google Scholar
• JCVI. JCVI statement on the annual influenza vaccination programme – extension of the programme to children. 2012;1–6.
   Google Scholar
• McNaughton R, Lynn E, Osborne V, Coughtrie A, Layton D, Shakir S. Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England. Drug Saf. 2016;39(4):323–33. doi:10.1007/s40264-015-0384-7.
   PubMed Web of Science ®Google Scholar
• Stockwell MS, Broder KR, Lewis P, Jakob K, Iqbal S, Fernandez N, Sharma D, Barrett A, LaRussa P. Assessing Fever Frequency After Pediatric Live Attenuated Versus Inactivated Influenza Vaccination. J Pediatric Infect Dis Soc. 2017. 6(3):e7–e14.
   PubMed Web of Science ®Google Scholar
• Carr S, Allison KJ, Van De Velde LA, Zhang K, English EY, Iverson A, Daw NC, Howard SC, Navid F, Rodriguez-Galindo C, et al. Safety and immunogenicity of live attenuated and inactivated influenza vaccines in children with cancer. J Infect Dis. 2011;204(10):1475–82. doi:10.1093/infdis/jir561.
   PubMed Web of Science ®Google Scholar
• King JCl Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, et al. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000;181(2):725–8. doi:10.1086/315246.
   PubMed Web of Science ®Google Scholar
• Mohn KG, Smith I, Sjursen H, Cox R. Immune responses after live attenuated influenza vaccination. Hum Vaccin Immunother. 2017:0. doi:10.1080/21645515.2017.1377376.
   PubMed Web of Science ®Google Scholar
• Caspard H, Gaglani M, Clipper L, Belongia EA, McLean HQ, Griffin MR, Talbot HK, Poehling KA, Peters TR, Veney N, et al. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children 2–17 years of age in 2013–2014 in the United States. Vaccine. 2016;34(1):77–82. doi:10.1016/j.vaccine.2015.11.010.
   PubMed Web of Science ®Google Scholar
• CDC. Frequently Asked Flu Questions 2017–2018 Influenza Season. 2017. https://www.cdc.gov/flu/about/season/flu-season-2017-2018.htm.
   Google Scholar
• Mameli C, D'Auria E, Erba P, Nannini P, Zuccotti GV. Influenza vaccine response: future perspectives. Expert Opin Biol Ther. 2017:1–5.
   PubMed Web of Science ®Google Scholar
• Turner PJ, Southern J, Andrews NJ, Miller EM. Erlewyn-Lajeunesse, and S.-S. Investigators, Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015;351:h6291. doi:10.1136/bmj.h6291.
   PubMed Web of Science ®Google Scholar
• Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ, Centers C. for Disease, and Prevention, National surveillance for asthma–United States, 1980–2004. MMWR Surveill Summ. 2007;56(8):1–54.
   PubMedGoogle Scholar
• Rudd RA, Moorman JE. Asthma incidence: data from the National Health Interview Survey, 1980–1996. J Asthma. 2007;44(1):65–70. doi:10.1080/02770900601125896.
   PubMed Web of Science ®Google Scholar
• Eggesbo M, Botten G, Halvorsen R, Magnus P. The prevalence of allergy to egg: a population-based study in young children. Allergy. 2001;56(5):403–11. doi:10.1034/j.1398-9995.2001.056005403.x.
   PubMed Web of Science ®Google Scholar
• Davies R, Pepys J. Egg allergy, influenza vaccine, and immunoglobulin E antibody. J Allergy Clin Immunol. 1976;57(4):373–83. doi:10.1016/0091-6749(76)90095-6.
   PubMed Web of Science ®Google Scholar
• Bierman CW, Shapiro GG, Pierson WE, Taylor JW, Foy HM, Fox JP. Safety of influenza vaccination in allergic children. J Infect Dis. 1977;136(Suppl):S652–5. doi:10.1093/infdis/136.Supplement_3.S652.
   PubMedGoogle Scholar
• Miller JR, Orgel HA, Meltzer EO. The safety of egg-containing vaccines for egg-allergic patients. J Allergy Clin Immunol. 1983;71(6):568–73. doi:10.1016/0091-6749(83)90438-4.
   PubMed Web of Science ®Google Scholar
• Murphy KR, Strunk RC. Safe administration of influenza vaccine in asthmatic children hypersensitive to egg proteins. J Pediatr. 1985;106(6):931–3. doi:10.1016/S0022-3476(85)80241-9.
   PubMed Web of Science ®Google Scholar
• Zeiger RS. Current issues with influenza vaccination in egg allergy. J Allergy Clin Immunol. 2002;110(6):834–40. doi:10.1067/mai.2002.129372.
   PubMed Web of Science ®Google Scholar
• Kelso JM, Li JT, Nicklas RA, Blessing-Moore J, Cox L, Lang DM, Oppenheimer J, Portnoy JM, Randolph C, Schuller DE, et al. P. Joint Task Force on Practice, A. Joint Task Forcce on Practice Parameters for, and Immunology, Adverse reactions to vaccines. Ann Allergy Asthma Immunol. 2009;103(4 Suppl 2):S1–14. doi:10.1016/S1081-1206(10)60350-X.
   PubMedGoogle Scholar
• Chung EY, Huang L, Schneider L. Safety of influenza vaccine administration in egg-allergic patients. Pediatrics. 2010;125(5):e1024–30. doi:10.1542/peds.2009-2512.
   PubMed Web of Science ®Google Scholar
• Ambrose CS, Wu X, Knuf M, Wutzler P. The efficacy of intranasal live attenuated influenza vaccine in children 2 through 17 years of age: a meta-analysis of 8 randomized controlled studies. Vaccine. 2012;30(5):886–92. doi:10.1016/j.vaccine.2011.11.104.
   PubMed Web of Science ®Google Scholar
• Belshe RB, Ambrose CS, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2–7 years of age. Vaccine. 2008;26(Suppl 4):D10–6. doi:10.1016/j.vaccine.2008.06.083.
   PubMedGoogle Scholar
• Gaglani MJ, Piedra PA, Riggs M, Herschler G, Fewlass C, Glezen WP, Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with intermittent wheezing in an open-label field trial. Pediatr Infect Dis J. 2008;27(5):444–52. doi:10.1097/INF.0b013e3181660c2e.
   PubMed Web of Science ®Google Scholar
• Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influenza With Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015–16 Influenza Season. Am J Transplant. 2015;15(10):2767–75. doi:10.1111/ajt.13505.
   PubMed Web of Science ®Google Scholar
• Iskander J, Broder K. Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience. Expert Rev Vaccines. 2008;7(1):75–82. doi:10.1586/14760584.7.1.75.
   PubMed Web of Science ®Google Scholar
• Hurwitz ES, Schonberger LB, Nelson DB, Holman RC. Guillain-Barre syndrome and the 1978–1979 influenza vaccine. N Engl J Med. 1981;304(26):1557–61. doi:10.1056/NEJM198106253042601.
   PubMed Web of Science ®Google Scholar
• Safranek TJ, Lawrence DN, Kurland LT, Culver DH, Wiederholt WC, Hayner NS, Osterholm MT, O'Brien P, Hughes JM. Reassessment of the association between Guillain-Barre syndrome and receipt of swine influenza vaccine in 1976–1977: results of a two-state study. Expert Neurology Group. Am J Epidemiol. 1991;133(9):940–51. doi:10.1093/oxfordjournals.aje.a115973.
   PubMed Web of Science ®Google Scholar
• Lasky T, Terracciano GJ, Magder L, Koski CL, Ballesteros M, Nash D, Clark S, Haber P, Stolley PD, Schonberger LB, et al. The Guillain-Barre syndrome and the 1992–1993 and 1993–1994 influenza vaccines. N Engl J Med. 1998;339(25):1797–802. doi:10.1056/NEJM199812173392501.
   PubMed Web of Science ®Google Scholar
• Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, Burwen DR, Cunningham F, Garman P, Greene SK, Lee GM, et al. HNGM-AW. Group. Association between Guillain-Barre syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis. Lancet. 2013;381(9876):1461–8. doi:10.1016/S0140-6736(12)62189-8.
   PubMed Web of Science ®Google Scholar
• Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, Zuber P, Hua W, Bonhoeffer J, Buttery J, et al. H.N.G.B.S.C. Global. International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines. Vaccine. 2013;31(40):4448–58. doi:10.1016/j.vaccine.2013.06.032.
   PubMed Web of Science ®Google Scholar
• Martin Arias LH, Sanz R, Sainz M, Treceno C, Carvajal A. Guillain-Barre syndrome and influenza vaccines: A meta-analysis. Vaccine. 2015;33(31):3773–8. doi:10.1016/j.vaccine.2015.05.013.
   PubMed Web of Science ®Google Scholar
• Wu J, Xu F, Lu L, Lu M, Miao L, Gao T, Ji W, Suo L, Liu D, Ma R, et al. Safety and effectiveness of a 2009 H1N1 vaccine in Beijing. N Engl J Med. 2010;363(25):2416–23. doi:10.1056/NEJMoa1006736.
   PubMed Web of Science ®Google Scholar
• Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ. 2011;343:d5956. doi:10.1136/bmj.d5956.
   PubMed Web of Science ®Google Scholar
• Ghaderi S, Gunnes N, Bakken IJ, Magnus P, Trogstad L, Haberg SE. Risk of Guillain-Barre syndrome after exposure to pandemic influenza A(H1N1)pdm09 vaccination or infection: a Norwegian population-based cohort study. Eur J Epidemiol. 2016;31(1):67–72. doi:10.1007/s10654-015-0047-0.
   PubMed Web of Science ®Google Scholar
• Burwen DR, Sandhu SK, MaCurdy TE, Kelman JA, Gibbs JM, Garcia B, Markatou M, Forshee RA, Izurieta HS, Ball R. G. Safety Surveillance Working, Surveillance for Guillain-Barre syndrome after influenza vaccination among the Medicare population, 2009–2010. Am J Public Health. 2012;102(10):1921–7.
   PubMed Web of Science ®Google Scholar
• Alcalde-Cabero E, Almazan-Isla J, Garcia Lopez FJ, Ara-Callizo JR, Avellanal F, Casasnovas C, Cemillan C, Cuadrado JI, Duarte J, Fernandez-Perez MD, et al. G.B.S.E.S.G. Spanish, Guillain-Barre syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database. BMC Neurol. 2016;16:75. doi:10.1186/s12883-016-0598-z.
   PubMed Web of Science ®Google Scholar
• Ahmed SS, Montomoli E, Pasini FL, Steinman L. The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy. Isr Med Assoc J. 2016;18(3-4):216–20.
   PubMed Web of Science ®Google Scholar
• Medical Products Agency (MPA). The MPA investigates reports of narcolepsy in patients vaccinated with Pandemrix. 2010.
   Google Scholar
• Nohynek H, Jokinen J, Partinen M, Vaarala O, Kirjavainen T, Sundman J, Himanen SL, Hublin C, Julkunen I, Olsen P, et al. AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS One. 2012;7(3):e33536. doi:10.1371/journal.pone.0033536.
   PubMed Web of Science ®Google Scholar
• Partinen M, Saarenpaa-Heikkila O, Ilveskoski I, Hublin C, Linna M, Olsen P, Nokelainen P, Alen R, Wallden T, Espo M, et al. Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland. PLoS One. 2012;7(3):e33723. doi:10.1371/journal.pone.0033723.
   PubMed Web of Science ®Google Scholar
• Dauvilliers Y, Arnulf I, Lecendreux M, Monaca Charley C, Franco P, Drouot X, d'Ortho MP, Launois S, Lignot S, et al. V.F.s.g. Narcoflu, Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France. Brain. 2013;136(Pt 8):2486–96. doi:10.1093/brain/awt187.
   PubMed Web of Science ®Google Scholar
• Ahmed SS, Volkmuth W, Duca J, Corti L, Pallaoro M, Pezzicoli A, Karle A, Rigat F, Rappuoli R, Narasimhan V, et al. Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2. Sci Transl Med. 2015;7(294):294ra105. doi:10.1126/scitranslmed.aab2354.
   PubMed Web of Science ®Google Scholar
• Oberle D, Pavel J, Rieck T, Weichert S, Schroten H, Keller-Stanislawski B, Tenenbaum T. Anaphylaxis After Immunization of Children and Adolescents in Germany. Pediatr Infect Dis J. 2016;35(5):535–41. doi:10.1097/INF.0000000000001073.
   PubMed Web of Science ®Google Scholar
• Trombetta CM, Perini D, Mather S, Temperton N, Montomoli E. Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future. Vaccines (Basel). 2014;2(4):707–34. doi:10.3390/vaccines2040707.
   PubMedGoogle Scholar
• EMA. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. EMA/PRAC/222346/2014. 2014;1–10.
   Google Scholar
• Neuzil KM, Edwards KM. Influenza vaccines in children. Semin Pediatr Infect Dis. 2002;13(3):174–81. doi:10.1053/spid.2002.125860.
   PubMedGoogle Scholar
• Esposito S, Tagliabue C, Tagliaferri L, Semino M, Longo MR, Principi N. Preventing influenza in younger children. Clin Microbiol Infect. 2012;18(Suppl 5):42–9. doi:10.1111/j.1469-0691.2012.03942.x.
   PubMedGoogle Scholar
• CDC. Flu Symptoms & Complications. 2016.
   Google Scholar
• Heikkinen T, Heinonen S. Effectiveness and safety of influenza vaccination in children: European perspective. Vaccine. 2011;29(43):7529–34. doi:10.1016/j.vaccine.2011.08.011.
   PubMed Web of Science ®Google Scholar
• Monto AS. Seasonal influenza and vaccination coverage. Vaccine. 2010;28(Suppl 4):D33–44. doi:10.1016/j.vaccine.2010.08.027.
   PubMed Web of Science ®Google Scholar
• Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013–2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016;12(5):1229–34. doi:10.1080/21645515.2015.1123357.
   PubMed Web of Science ®Google Scholar
• Halasa NB, Gerber MA, Berry AA, Anderson EL, Winokur P, Keyserling H, Eckard AR, Hill H, Wolff MC, McNeal MM, et al. Safety and Immunogenicity of Full-Dose Trivalent Inactivated Influenza Vaccine (TIV) Compared With Half-Dose TIV Administered to Children 6 Through 35 Months of Age. J Pediatric Infect Dis Soc. 2015;4(3):214–24. doi:10.1093/jpids/piu061.
   PubMed Web of Science ®Google Scholar
• Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, et al. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011;128(2):e276–89. doi:10.1542/peds.2010-2777.
   PubMed Web of Science ®Google Scholar
• Pavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, et al. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013;9(9):1978–88. doi:10.4161/hv.25363.
   PubMed Web of Science ®Google Scholar
• Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, Fries L. Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6–35 Months: A Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2012;1(1):55–63. doi:10.1093/jpids/pis012.
   PubMedGoogle Scholar
• Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J. 2012;31(5):494–500. doi:10.1097/INF.0b013e31824bb179.
   PubMed Web of Science ®Google Scholar
• Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016;34(2):230–6. doi:10.1016/j.vaccine.2015.11.040.
   PubMed Web of Science ®Google Scholar
• Esposito S, Daleno C, Picciolli I, Tagliaferri L, Scala A, Prunotto G, Montinaro V, Galeone C, Principi N. Immunogenicity and safety of intradermal influenza vaccine in children. Vaccine. 2011;29(44):7606–10. doi:10.1016/j.vaccine.2011.08.021.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Groth N, Karvonen A, Borkowski A, Pellegrini M. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine. 2009;27(45):6291–5. doi:10.1016/j.vaccine.2009.02.004.
   PubMed Web of Science ®Google Scholar
• Carmona Martinez A, Salamanca de la Cueva I, Boutet P, Vanden Abeele C, Smolenov I, Devaster JM. A phase 1, open-label safety and immunogenicity study of an AS03-adjuvanted trivalent inactivated influenza vaccine in children aged 6 to 35 months. Hum Vaccin Immunother. 2014;10(7):1959–68. doi:10.4161/hv.28743.
   PubMed Web of Science ®Google Scholar
• Nolan T, Bravo L, Ceballos A, Mitha E, Gray G, Quiambao B, Patel SS, Bizjajeva S, Bock H, Nazaire-Bermal N, et al. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014;32(46):6146–56. doi:10.1016/j.vaccine.2014.08.068.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Forsten A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Hum Vaccin Immunother. 2015;11(8):2102–12. doi:10.1080/21645515.2015.1044167.
   PubMed Web of Science ®Google Scholar
• Black S, Della Cioppa G, Malfroot A, Nacci P, Nicolay U, Pellegrini M, Sokal E, Vertruyen A. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine. 2010;28(45):7331–6. doi:10.1016/j.vaccine.2010.08.075.
   PubMed Web of Science ®Google Scholar
• Manini I, Domnich A, Amicizia D, Rossi S, Pozzi T, Gasparini R, Panatto D, Montomoli E. Flucelvax (Optaflu) for seasonal influenza. Expert Rev Vaccines. 2015;14(6):789–804. doi:10.1586/14760584.2015.1039520.
   PubMed Web of Science ®Google Scholar
• Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, et al. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012–2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015;4(3):242–51. doi:10.1093/jpids/piu098.
   PubMed Web of Science ®Google Scholar
• Wang L, Chandrasekaran V, Domachowske JB, Li P, Innis BL, Jain VK. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial. J Pediatric Infect Dis Soc. 2016;5(2):170–9. doi:10.1093/jpids/piv041.
   PubMed Web of Science ®Google Scholar
• Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998;338(20):1405–12. doi:10.1056/NEJM199805143382002.
   PubMed Web of Science ®Google Scholar
• Klick B, Durrani S, Chan KH, Ip DK, Chou ES, Kwok HK, Ng S, Chiu SS, Peiris JS, Leung GM, et al. Live attenuated seasonal and pandemic influenza vaccine in school-age children: a randomized controlled trial. Vaccine. 2013;31(15):1937–43. doi:10.1016/j.vaccine.2013.02.017.
   PubMed Web of Science ®Google Scholar
• Baxter R, Eaton A, Hansen J, Aukes L, Caspard H, Ambrose CS. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2–49years. Vaccine. 2017;35(9):1254–1258. doi:10.1016/j.vaccine.2017.01.062.
   PubMed Web of Science ®Google Scholar
• WHO. Recommendations and laboratory procedures for detection of avian influenza A(H5N1) virus in specimens from suspected human cases. 2007:1–28.
   Google Scholar
• Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, et al. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359–69. doi:10.1080/21645515.2015.1063754.
   PubMed Web of Science ®Google Scholar
• Lu CY, Shao PL, Chang LY, Huang YC, Chiu CH, Hsieh YC, Lin TY, Huang LM. Immunogenicity and safety of a monovalent vaccine for the 2009 pandemic influenza virus A (H1N1) in children and adolescents. Vaccine. 2010;28(36):5864–70. doi:10.1016/j.vaccine.2010.06.059.
   PubMed Web of Science ®Google Scholar
• Knuf M, Leroux-Roels G, Rumke HC, Abarca K, Rivera L, Lattanzi M, Pedotti P, Arora A, Kieninger-Baum D, Della Cioppa G. Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. Vaccine. 2015;33(1):174–81. doi:10.1016/j.vaccine.2014.10.085.
   PubMed Web of Science ®Google Scholar
• Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA. I. Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network Rapid Trials, Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011;30(5):402–7. doi:10.1097/INF.0b013e3182068f33.
   PubMed Web of Science ®Google Scholar
• Nolan T, Roy-Ghanta S, Montellano M, Weckx L, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Safadi MA, Cruz-Valdez A, Litao S, et al. Relative efficacy of AS03-adjuvanted pandemic influenza A(H1N1) vaccine in children: results of a controlled, randomized efficacy trial. J Infect Dis. 2014;210(4):545–57. doi:10.1093/infdis/jiu173.
   PubMed Web of Science ®Google Scholar
• Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010;375(9708):41–8. doi:10.1016/S0140-6736(09)62026-2.
   PubMed Web of Science ®Google Scholar
• Knuf M, Leroux-Roels G, Rumke H, Rivera L, Pedotti P, Arora AK, Lattanzi M, Kieninger D, Cioppa GD. Immunogenicity and safety of cell-derived MF59(R)-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358–76. doi:10.4161/21645515.2014.987014.
   PubMed Web of Science ®Google Scholar
• Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, et al. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015;9(2):68–77. doi:10.1111/irv.12295.
   PubMed Web of Science ®Google Scholar
• WHO. Weekly epidemiological record. Vaccines against influenza WHO position paper –November 2012. 2012:461–76.
   Google Scholar
• Michiels B, Govaerts F, Remmen R, Vermeire E, Coenen S. A systematic review of the evidence on the effectiveness and risks of inactivated influenza vaccines in different target groups. Vaccine. 2011;29(49):9159–70. doi:10.1016/j.vaccine.2011.08.008.
   PubMed Web of Science ®Google Scholar
• Kieninger D, Sheldon E, Lin WY, Yu CJ, Bayas JM, Gabor JJ, Esen M, Fernandez Roure JL, Narejos Perez S, Alvarez Sanchez C, et al. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/ = 18 years. BMC Infect Dis. 2013;13:343. doi:10.1186/1471-2334-13-343.
   PubMed Web of Science ®Google Scholar
• Gorse GJ, Falsey AR, Johnson CM, Morrison D, Fried DL, Ervin JE, Greenberg DP, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18–64 years of age. Vaccine. 2013;31(50):6034–40. doi:10.1016/j.vaccine.2013.09.012.
   PubMed Web of Science ®Google Scholar
• Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32(39):5027–34. doi:10.1016/j.vaccine.2014.07.013.
   PubMed Web of Science ®Google Scholar
• Mo Z, Nong Y, Liu S, Shao M, Liao X, Go K, Lavis N. Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China. Hum Vaccin Immunother. 2017;13(6):1–7. doi:10.1080/21645515.2017.1285475.
   Web of Science ®Google Scholar
• Song JY, Cheong HJ, Lee J, Woo HJ, Wie SH, Lee JS, Kim SW, Noh JY, Choi WS, Kim H, et al. Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial. Vaccine. 2015;33(41):5437–44. doi:10.1016/j.vaccine.2015.08.030.
   PubMed Web of Science ®Google Scholar
• Roggelin L, Vinnemeier CD, Meyer S, Witte K, Marx L, Theess W, Burchard GD, Rolling T, Cramer JP. A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine–Assessing the immunogenicity and safety in an open label, uncontrolled study. Hum Vaccin Immunother. 2015;11(10):2370–5. doi:10.1080/21645515.2015.1064570.
   PubMed Web of Science ®Google Scholar
• Groth N, Montomoli E, Gentile C, Manini I, Bugarini R, Podda A. Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial. Vaccine. 2009;27(5):786–91. doi:10.1016/j.vaccine.2008.11.003.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Saway W, Gouaux J, Baron M, Baker J, Denis M, Jordanov E, Landolfi V, Yau E. Safety and immunogenicity of high-dose trivalent inactivated influenza vaccine in adults 50–64 years of age. Vaccine. 2015;33(51):7188–93. doi:10.1016/j.vaccine.2015.10.131.
   PubMed Web of Science ®Google Scholar
• Tsurudome Y, Kimachi K, Okada Y, Matsuura K, Ooyama Y, Ibaragi K, Kino Y, Ueda K. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan. Microbiol Immunol. 2015;59(10):597–604. doi:10.1111/1348-0421.12316.
   PubMed Web of Science ®Google Scholar
• Bart S, Cannon K, Herrington D, Mills R, Forleo-Neto E, Lindert K, Abdul Mateen A. Immunogenicity and safety of a cell culture-based quadrivalent influenza vaccine in adults: A Phase III, double-blind, multicenter, randomized, non-inferiority study. Hum Vaccin Immunother. 2016;12(9):2278–88. doi:10.1080/21645515.2016.1182270.
   PubMed Web of Science ®Google Scholar
• Treanor JT, Albano FR, Sawlwin DC, Graves Jones A, Airey J, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Vaccine. 2017;35(15):1856–1864. doi:10.1016/j.vaccine.2017.02.066.
   PubMed Web of Science ®Google Scholar
• Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok((R)) versus licensed inactivated influenza vaccine in healthy, medically stable adults >/ = 50 years of age. Vaccine. 2015;33(48):6622–8. doi:10.1016/j.vaccine.2015.10.097.
   PubMed Web of Science ®Google Scholar
• Kaka AS, Filice GA, Myllenbeck S, Nichol KL. Comparison of Side Effects of the 2015–2016 High-Dose, Inactivated, Trivalent Influenza Vaccine and Standard Dose, Inactivated, Trivalent Influenza Vaccine in Adults >/ = 65 Years. Open Forum Infect Dis. 2017;4(1):ofx001. doi:10.1093/ofid/ofx001.
   PubMed Web of Science ®Google Scholar
• Wilkinson K, Wei Y, Szwajcer A, Rabbani R, Zarychanski R, Abou-Setta AM, Mahmud SM. Efficacy and safety of high-dose influenza vaccine in elderly adults: A systematic review and meta-analysis. Vaccine. 2017;35(21):2775–2780. doi:10.1016/j.vaccine.2017.03.092.
   PubMed Web of Science ®Google Scholar
• Tsang TK, Cauchemez S, Perera RA, Freeman G, Fang VJ, Ip DK, Leung GM, Malik Peiris JS, Cowling BJ. Association between antibody titers and protection against influenza virus infection within households. J Infect Dis. 2014;210(5):684–92. doi:10.1093/infdis/jiu186.
   PubMed Web of Science ®Google Scholar
• Arakane R, Nakatani H, Fujisaki E, Takahama A, Ishida K, Yoshiike M, Nakayama T, Takeshita F. Immunogenicity and safety of the new intradermal influenza vaccine in adults and elderly: A randomized phase 1/2 clinical trial. Vaccine. 2015;33(46):6340–50. doi:10.1016/j.vaccine.2015.09.010.
   PubMed Web of Science ®Google Scholar
• Pileggi C, Lotito F, Bianco A, Nobile CG, Pavia M. Immunogenicity and safety of intradermal influenza vaccine in immunocompromized patients: a meta-analysis of randomized controlled trials. BMC Infect Dis. 2015;15:427. doi:10.1186/s12879-015-1161-z.
   PubMed Web of Science ®Google Scholar
• Chi RC, Rock MT, Neuzil KM. Immunogenicity and safety of intradermal influenza vaccination in healthy older adults. Clin Infect Dis. 2010;50(10):1331–8. doi:10.1086/652144.
   PubMed Web of Science ®Google Scholar
• Nichol KL, Mendelman PM, Mallon KP, Jackson LA, Gorse GJ, Belshe RB, Glezen WP, Wittes J. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA. 1999;282(2):137–44. doi:10.1001/jama.282.2.137.
   PubMed Web of Science ®Google Scholar
• De Villiers PJ, Steele AD, Hiemstra LA, Rappaport R, Dunning AJ, Gruber WC, Forrest BD, L.E.S.T. Network, Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older. Vaccine. 2009;28(1):228–34. doi:10.1016/j.vaccine.2009.09.092.
   PubMed Web of Science ®Google Scholar
• Forrest BD, Steele AD, Hiemstra L, Rappaport R, Ambrose CS, Gruber WC. A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine. 2011;29(20):3633–9. doi:10.1016/j.vaccine.2011.03.029.
   PubMed Web of Science ®Google Scholar
• Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011;29(50):9391–7. doi:10.1016/j.vaccine.2011.09.109.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009;361(25):2414–23. doi:10.1056/NEJMoa0908535.
   PubMed Web of Science ®Google Scholar
• Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009;361(25):2424–35. doi:10.1056/NEJMoa0907650.
   PubMed Web of Science ®Google Scholar
• Fukase H, Furuie H, Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Yotsuyanagi H, Kusadokoro H, Sawata H, et al. Assessment of the immunogenicity and safety of varying doses of an MF59(R)-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects. Vaccine. 2012;30(33):5030–7. doi:10.1016/j.vaccine.2012.03.053.
   PubMed Web of Science ®Google Scholar
• Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009;361(25):2405–13. doi:10.1056/NEJMoa0907413.
   PubMed Web of Science ®Google Scholar
• Kubavat AH, Mittal R, Patel PM, Jarsaniya DH, Pawar PR. H.N.V.S. Group, A clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine; VaxiFlu-S) in healthy Indian adult population. J Postgrad Med. 2011;57(2):102–8. doi:10.4103/0022-3859.81860.
   PubMed Web of Science ®Google Scholar
• Hatz C, Cramer JP, Vertruyen A, Schwarz TF, von Sonnenburg F, Borkowski A, Lattanzi M, Hilbert AK, Cioppa GD, Leroux-Roels G. A randomised, single-blind, dose-range study to assess the immunogenicity and safety of a cell-culture-derived A/H1N1 influenza vaccine in adult and elderly populations. Vaccine. 2012;30(32):4820–7. doi:10.1016/j.vaccine.2012.05.013.
   PubMed Web of Science ®Google Scholar
• Reisinger KS, Holmes SJ, Pedotti P, Arora AK, Lattanzi M. A dose-ranging study of MF59((R))-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination. Hum Vaccin Immunother. 2014;10(8):2395–407. doi:10.4161/hv.29393.
   PubMed Web of Science ®Google Scholar
• Sobhanie M, Matsuoka Y, Jegaskanda S, Fitzgerald T, Mallory R, Chen Z, Luke C, Treanor J, Subbarao K. Evaluation of the Safety and Immunogenicity of a Candidate Pandemic Live Attenuated Influenza Vaccine (pLAIV) Against Influenza A(H7N9). J Infect Dis. 2016;213(6):922–9. doi:10.1093/infdis/jiv526.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Forsten A, Herbinger KH, Cioppa GD, Beygo J, Borkowski A, Groth N, Bennati M, von Sonnenburg F. Safety and immunogenicity of an MF59((R))-adjuvanted A/H5N1 pre-pandemic influenza vaccine in adults and the elderly. Vaccine. 2012;30(7):1388–96. doi:10.1016/j.vaccine.2011.12.009.
   PubMed Web of Science ®Google Scholar
• Madan A, Ferguson M, Sheldon E, Segall N, Chu L, Toma A, Rheault P, Friel D, Soni J, Li P, et al. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial. Vaccine. 2017;35(10):1431–1439. doi:10.1016/j.vaccine.2017.01.054.
   PubMed Web of Science ®Google Scholar
• Esposito S, Marchisio P, Droghetti R, Lambertini L, Faelli N, Bosis S, Tosi S, Begliatti E, Principi N. Influenza vaccination coverage among children with high-risk medical conditions. Vaccine. 2006;24(24):5251–5. doi:10.1016/j.vaccine.2006.03.059.
   PubMed Web of Science ®Google Scholar
• CDC. Prevention and Control of Influenza with Vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. Morb Mortal Wkly Rep (MMWR). 2010;59(RR08):1–62.
   Google Scholar
• Santos AJ, Kislaya I, Machado A, Nunes B. Beliefs and attitudes towards the influenza vaccine in high-risk individuals. Epidemiol Infect. 2017;145(9):1786–1796. doi:10.1017/S0950268817000814.
   PubMed Web of Science ®Google Scholar
• Halasa NB, Savani BN, Asokan I, Kassim A, Simons R, Summers C, Bourgeois J, Clifton C, Vaughan LA, Lucid C, et al. Randomized Double-Blind Study of the Safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplantation Patients. Biol Blood Marrow Transplant. 2016;22(3):528–35. doi:10.1016/j.bbmt.2015.12.003.
   PubMed Web of Science ®Google Scholar
• Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478–84. doi:10.1080/21645515.2015.1076599.
   PubMed Web of Science ®Google Scholar
• Seo YB, Baek JH, Lee J, Song JY, Lee JS, Cheong HJ, Kim WJ. Long-Term Immunogenicity and Safety of a Conventional Influenza Vaccine in Patients with Type 2 Diabetes. Clin Vaccine Immunol. 2015;22(11):1160–5. doi:10.1128/CVI.00288-15.
   PubMed Web of Science ®Google Scholar
• Lu Y, Jacobson DL, Ashworth LA, Grand RJ, Meyer AL, McNeal MM, Gregas MC, Burchett SK, Bousvaros A. Immune response to influenza vaccine in children with inflammatory bowel disease. Am J Gastroenterol. 2009;104(2):444–53. doi:10.1038/ajg.2008.120.
   PubMed Web of Science ®Google Scholar
• Hakim H, Allison KJ, Van de Velde LA, Tang L, Sun Y, Flynn PM, McCullers JA. Immunogenicity and safety of high-dose trivalent inactivated influenza vaccine compared to standard-dose vaccine in children and young adults with cancer or HIV infection. Vaccine. 2016;34(27):3141–3148. doi:10.1016/j.vaccine.2016.04.053.
   PubMed Web of Science ®Google Scholar
• Benchimol EI, Hawken S, Kwong JC, Wilson K. Safety and utilization of influenza immunization in children with inflammatory bowel disease. Pediatrics. 2013;131(6):e1811–20. doi:10.1542/peds.2012-3567.
   PubMed Web of Science ®Google Scholar
• Cordero E, Roca-Oporto C, Bulnes-Ramos A, Aydillo T, Gavalda J, Moreno A, Torre-Cisneros J, Montejo JM, Fortun J, Munoz P, et al. TS. Group, Two Doses of Inactivated Influenza Vaccine Improve Immune Response in Solid Organ Transplant Recipients: Results of TRANSGRIPE 1–2, a Randomized Controlled Clinical Trial. Clin Infect Dis. 2017;64(7):829–838. doi:10.1093/cid/ciw855.
   PubMed Web of Science ®Google Scholar
• Branagan AR, Duffy E, Albrecht RA, Cooper DL, Seropian S, Parker TL, Gan G, Li F, Zelterman D, Boddupalli CS, et al. Clinical and Serologic Responses After a Two-dose Series of High-dose Influenza Vaccine in Plasma Cell Disorders: A Prospective, Single-arm Trial. Clin Lymphoma Myeloma Leuk. 2017;17(5):296–304 e2. doi:10.1016/j.clml.2017.02.025.
   PubMed Web of Science ®Google Scholar
• Saito T, Ohfuji S, Matsumura T, Saito T, Maeda K, Maeda A, Fukushima W, Fujimura H, Sakoda S, Hirota Y. Safety of a Pandemic Influenza Vaccine and the Immune Response in Patients with Duchenne Muscular Dystrophy. Intern Med. 2015;54(10):1199–205. doi:10.2169/internalmedicine.54.1186.
   PubMed Web of Science ®Google Scholar
• McManus M, Frangoul H, McCullers JA, Wang L, O'Shea A, Halasa N. Safety of high dose trivalent inactivated influenza vaccine in pediatric patients with acute lymphoblastic leukemia. Pediatr Blood Cancer. 2014;61(5):815–20. doi:10.1002/pbc.24863.
   PubMed Web of Science ®Google Scholar
• Tanaka S, Saikusa T, Katafuchi Y, Ushijima K, Ohtsu Y, Tsumura N, Ito Y. Serologic response after vaccination against influenza (A/H1N1)pdm09 in children with renal disease receiving oral immunosuppressive drugs. Vaccine. 2015;33(38):5000–4. doi:10.1016/j.vaccine.2015.06.049.
   PubMed Web of Science ®Google Scholar
• Fausto F, Paolo P, Anna O, Carlo S. Excess mortality in Italy: Should we care about low influenza vaccine uptake? Scand J Public Health. 2017:1403494817720102.
   Web of Science ®Google Scholar
• Rizzo C, Rezza G, Ricciardi W. Strategies in recommending influenza vaccination in Europe and US. Hum Vaccin Immunother. 2017:0. doi:10.1080/21645515.2017.1367463. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Poland GA, Whitaker JA, Poland CM, Ovsyannikova IG, Kennedy RB. Vaccinology in the third millennium: scientific and social challenges. Curr Opin Virol. 2016;17:116–25. doi:10.1016/j.coviro.2016.03.003.
   PubMed Web of Science ®Google Scholar
• Gianchecchi E, Fierabracci A. Gene/environment interactions in the pathogenesis of autoimmunity: new insights on the role of Toll-like receptors. Autoimmun Rev. 2015;14(11):971–83. doi:10.1016/j.autrev.2015.07.006.
   PubMed Web of Science ®Google Scholar
• CDC. Influenza (Flu) Vaccine Safety. 2015. https://www.cdc.gov/flu/protect/vaccine/vaccinesafety.htm.
   Google Scholar
• CDC. Influenza (Flu) Vaccine (Inactivated or Recombinant): What you need to know. 2015.
   Google Scholar
• Neuzil KM, Bresee JS, de la Hoz F, Johansen K, Karron RA, Krishnan A, Madhi SA, Mangtani P, Spiro DJ, Ortiz JR. W.H.O.P.P.C.f.N.-G.I.V.A. Group, Data and product needs for influenza immunization programs in low- and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines. Vaccine. 2017;35(43):5734–5737. doi:10.1016/j.vaccine.2017.08.088.
   PubMed Web of Science ®Google Scholar
• WHO. Global Vaccine Action Plan 2011–2020. 2017. http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/.
   Google Scholar