1,139
Views
18
CrossRef citations to date
0
Altmetric
Research Paper

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

, , , , , , , , , , , , , , , & show all
Pages 1978-1988 | Received 11 Mar 2013, Accepted 11 Jun 2013, Published online: 19 Jun 2013

References

  • Viboud C, Boëlle PY, Cauchemez S, Lavenu A, Valleron AJ, Flahault A, et al. Risk factors of influenza transmission in households. Br J Gen Pract 2004; 54:684 - 9; PMID: 15353055
  • Heikkinen T, Silvennoinen H, Peltola V, Ziegler T, Vainionpaa R, Vuorinen T, et al. Burden of influenza in children in the community. J Infect Dis 2004; 190:1369 - 73; http://dx.doi.org/10.1086/424527; PMID: 15378427
  • Izurieta HS, Thompson WW, Kramarz P, Shay DK, Davis RL, DeStefano F, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med 2000; 342:232 - 9; http://dx.doi.org/10.1056/NEJM200001273420402; PMID: 10648764
  • Neuzil KM, Mellen BG, Wright PF, Mitchel EF Jr., Griffin MR. The effect of influenza on hospitalizations, outpatient visits, and courses of antibiotics in children. N Engl J Med 2000; 342:225 - 31; http://dx.doi.org/10.1056/NEJM200001273420401; PMID: 10648763
  • Neuzil KM, Zhu Y, Griffin MR, Edwards KM, Thompson JM, Tollefson SJ, et al. Burden of interpandemic influenza in children younger than 5 years: a 25-year prospective study. J Infect Dis 2002; 185:147 - 52; http://dx.doi.org/10.1086/338363; PMID: 11807687
  • Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)--United States, 2012-13 influenza season. MMWR Morb Mortal Wkly Rep 2012; 61:613 - 8; PMID: 22895385
  • Mereckiene J, Cotter S, Nicoll A, Levy-Bruhl D, Ferro A, Tridente G, et al. National seasonal influenza vaccination survey in Europe, 2008. Euro Surveill 2008; 13:19017; PMID: 18947524
  • Public Health Agency of Canada National Advisory Committee on Immunization. Statement on seasonal influenza vaccine for 2011-2012. 2011; 37 http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-5/ (Accessed 30 April 2013)
  • Usonis V, Anca I, André F, Chlibek R, Ivaskeviciene I, Mangarov A, et al, Central European Vaccination Advisory Group. Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for influenza vaccination in children. BMC Infect Dis 2010; 10:168; http://dx.doi.org/10.1186/1471-2334-10-168; PMID: 20546586
  • Steinhoff MC. Influenza in young children: burden, immunisation, and policy. Lancet Infect Dis 2011; 11:2 - 3; http://dx.doi.org/10.1016/S1473-3099(10)70263-2; PMID: 21106444
  • UK Department of Health. Influenza. Green Book 2012; 19-v4_71 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/147958/Green-Book-Chapter-19-v4_71.pdf (Accessed 30 April 2013)
  • Wright PF, Dolin R, La Montagne JR. From the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, the Center for Disease Control, and the Bureau of Biologics of the Food and Drug Administration. Summary of clinical trials of influenza vaccines--II. J Infect Dis 1976; 134:633 - 8; http://dx.doi.org/10.1093/infdis/134.6.633; PMID: 794423
  • Langley JM, Scheifele DW, Quach C, Vanderkooi OG, Ward B, McNeil S, et al. Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine 2012; 30:3389 - 94; http://dx.doi.org/10.1016/j.vaccine.2012.03.046; PMID: 22469860
  • Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, et al. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics 2011; 128:e276 - 89; http://dx.doi.org/10.1542/peds.2010-2777; PMID: 21768314
  • FDA News Release. FDA approves seasonal influenza vaccine Fluarix for pediatric use; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187156.htm (Accessed 30 April 2013)
  • Treanor JJ, Campbell JD, Brady RC, Keitel WA, Drame M, Jain VK, et al. Rapid licensure of a new, inactivated influenza vaccine in the United States. Hum Vaccin 2005; 1:239 - 44; http://dx.doi.org/10.4161/hv.1.6.2376; PMID: 17012883
  • Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, et al. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J 2010; 29:924 - 30; http://dx.doi.org/10.1097/INF.0b013e3181e075be; PMID: 20431425
  • Campbell JD, Chambers CV, Brady RC, Caldwell MC, Bennett NL, Fourneau MA, et al. Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: a randomized study in US adults. Hum Vaccin 2011; 7:81 - 8; http://dx.doi.org/10.4161/hv.7.1.13553; PMID: 21285532
  • Frank AL, Webster RG, Glezen WP, Cate TR. Immunogenicity of influenza A/USSR (H1N1) subunit vaccine in unprimed young adults. J Med Virol 1981; 7:135 - 42; http://dx.doi.org/10.1002/jmv.1890070207; PMID: 7264612
  • Glezen WP, Kasel JA, Webster RG, Taber LH. Alternative approaches to immunization of children with inactivated influenza virus vaccines. J Infect Dis 1977; 136:Suppl S677 - 82; http://dx.doi.org/10.1093/infdis/136.Supplement_3.S677; PMID: 606791
  • Webster RG, Glezen WP, Hannoun C, Laver WG. Potentiation of the immune response to influenza virus subunit vaccines. J Immunol 1977; 119:2073 - 7; PMID: 915292
  • Webster RG, Kasel JA, Couch RB, Laver WG. Influenza virus subunit vaccines. II. Immunogenicity and original antigenic sin in humans. J Infect Dis 1976; 134:48 - 58; http://dx.doi.org/10.1093/infdis/134.1.48; PMID: 59787
  • Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev 2008; 16:CD004879
  • Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, et al. 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; 1:55 - 63; http://dx.doi.org/10.1093/jpids/pis012; PMID: 23687572
  • Esposito S, Marchisio P, Montinaro V, Bianchini S, Weverling GJ, Pariani E, et al. The immunogenicity and safety of a single 0.5 mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: data from a randomized, Phase III study. Vaccine 2012; 30:7005 - 12; http://dx.doi.org/10.1016/j.vaccine.2012.09.069; PMID: 23059357
  • Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis 2011; 204:1879 - 85; http://dx.doi.org/10.1093/infdis/jir661; PMID: 21998477
  • Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg (Lond) 1972; 70:767 - 77; http://dx.doi.org/10.1017/S0022172400022610; PMID: 4509641
  • Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol 2010; 10:18; http://dx.doi.org/10.1186/1471-2288-10-18; PMID: 20210985
  • Rimmelzwaan GF, McElhaney JE. Correlates of protection: novel generations of influenza vaccines. Vaccine 2008; 26:Suppl 4 D41 - 4; http://dx.doi.org/10.1016/j.vaccine.2008.07.043; PMID: 19230158
  • Black S, Nicolay U, Vesikari T, Knuf M, Del Giudice G, Della Cioppa G, et al. Hemagglutination inhibition antibody titers as a correlate of protection for inactivated influenza vaccines in children. Pediatr Infect Dis J 2011; 30:1081 - 5; http://dx.doi.org/10.1097/INF.0b013e3182367662; PMID: 21983214
  • Block SL, Falloon J, Hirschfield JA, Krilov LR, Dubovsky F, Yi T, et al. Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children. Pediatr Infect Dis J 2012; 31:745 - 51; http://dx.doi.org/10.1097/INF.0b013e31825687b0; PMID: 22466322
  • U.S. Food and Drug Administration. FDA approves first quadrivalent vaccine to prevent seasonal influenza. February 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm (Accessed 30 April 2013)
  • Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, et al. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis 2013; 207:1878 - 87; http://dx.doi.org/10.1093/infdis/jit091; PMID: 23470848
  • U.S. Department of Health and Human Services FaDA. Approval Letter- Fluarix Quadrivalent. December 14, 2012http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm332484.htm (Accessed 30 April 2013)
  • Hehme NW, Künzel W, Petschke F, Türk G, Raderecht C, van Hoecke C, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Investig 2002; 22:751 - 69; http://dx.doi.org/10.2165/00044011-200222110-00004
  • US Food and Drug Administration. Guidance for industry. Clinical data needed to support the licensure of seasonal inactivated influenza vaccines 30th April 2009. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074794.htm (Accessed 30 April 2013)