The immunogenicity and safety of a single 0.5mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: Data from a randomized, Phase III study

Vaccine

Volumn 30, Issue 49, 2012, Pages 7005-7012

  Esposito, Susanna ^a   Marchisio, Paola ^a   Montinaro, Valentina ^a   Bianchini, Sonia ^a   Weverling, Gerrit Jan ^b   Pariani, Elena ^a   Amendola, Antonella ^a   Fabiano, Valentina ^c   Pivetti, Valentina ^c   Zanetti, Alessandro ^a   Zuccotti, Gian Vincenzo ^c  

^a UNIVERSITY OF MILAN   (Italy)

^b CRUCELL HOLLAND BV   (Netherlands)

^c UNIVERSITY OF MILAN   (Italy)

Author keywords

Children; Immunogenicity; Influenza; Vaccination schedule; Virosomal

Indexed keywords

INFLUENZA VACCINE; VIROSOME VACCINE;

ARTICLE; CHILD; CONTROLLED STUDY; DRUG TOLERABILITY; ERYTHEMA; EXPLORATORY RESEARCH; FEMALE; FEVER; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; INFANT; INFLUENZA; LICENSING; MALAISE; MALE; MULTICENTER STUDY; NORMAL HUMAN; PAIN; PHASE 3 CLINICAL TRIAL; PRACTICE GUIDELINE; PRESCHOOL CHILD; PRIORITY JOURNAL; SHIVERING; SINGLE DRUG DOSE; SKIN INDURATION;

ANTIBODIES, VIRAL; CHILD, PRESCHOOL; DRUG TOXICITY; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFANT; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; VACCINATION; VACCINES, SUBUNIT; VACCINES, VIROSOME;

EID: 84869090289     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.09.069     Document Type: Article

References (36)

1. Centers for Disease Control and Prevention Influenza vaccination coverage among children aged 6 months-18 years - eight immunization information system sentinel sites, United States, 2008-09 influenza season. MMWR 2009, 58(38):1059-1062.
2. Neuzil K.M., Jackson L.A., Nelson J., Klimov A., Cox N., Bridges C.B., et al. Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. J Infect Dis 2006, 194(8):1032-1039.
3. Centers for Disease Control and Prevention Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR 2011, 60(33):1128-1132.
4. Jackson L.A., Neuzil K.M., Baggs J., Davis R.L., Black S., Yamasaki K.M., et al. Compliance with the recommendations for 2 doses of trivalent inactivated influenza vaccine in children less than 9 years of age receiving influenza vaccine for the first time: a Vaccine Safety Datalink study. Pediatrics 2006, 118(5):2032-2037.
5. Ritzwoller D.P., Bridges C.B., Shetterly S., Yamasaki K., Kolczak M., France E.K. Effectiveness of the 2003-2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics 2005, 116(1):153-159.
6. Principi N., Esposito S., Marchisio P., Gasparini R., Crovari P. Socioeconomic impact of influenza on healthy children and their families. Pediatr Infect Dis J 2003, 22(10 Suppl.):S207-S210.
7. Reichert T.A., Sugaya N., Fedson D.S., Glezen W.P., Simonsen L., Tashiro M. The Japanese experience with vaccinating schoolchildren against influenza. N Engl J Med 2001, 344(12):889-896.
8. Piedra P.A., Gaglani M.J., Kozinetz C.A., Herschler G., Riggs M., Griffith M., et al. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine 2005, 23(13):1540-1548.
9. Englund J.A., Walter E.B., Fairchok M.P., Monto A.S., Neuzil K.M. A comparison of 2 influenza vaccine schedules in 6- to 23-month-old children. Pediatrics 2005, 115(4):1039-1047.
10. Esposito S., Marchisio P., Ansaldi F., Bianchini S., Pacei M., Baggi E., et al. A randomized clinical trial assessing immunogenicity and safety of a double dose of virosomal-adjuvanted influenza vaccine administered to unprimed children aged 6-35 months. Vaccine 2010, 28(38):6137-6144.
11. Herzog C., Hartmann K., Kunzi V., Kürsteiner O., Mischler R., Lazar H., et al. Eleven years of Inflexal V - a virosomal adjuvanted influenza vaccine. Vaccine 2009, 27(33):4381-4387.
12. European Agency for the Evaluation of Medicinal Products (EMEA) - Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96). London; 1997.
13. World Health Organization WHO manual on animal influenza diagnosis and surveillance 2002, World Health Organization, Geneva, Switzerland.
14. Centers for Disease Control and Prevention. The Flu Season. Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD); 2011 [accessed 29.03.12].
15. Belshe R.B. The need for quadrivalent vaccine against seasonal influenza. Vaccine 2010, 28(Suppl. 4):D45-D53.
16. Olivier C.W. Influenza vaccination coverage rate in children: reasons for a failure and how to go forward. Hum Vaccin Immunother 2012, 8(1). [Epub January 1].
17. Fairbrother G., Cassedy A., Ortega-Sanchez I.R., Szilagyi P.C., Edwards K.M., Molinary N.A., et al. High costs of influenza: direct medical costs of influenza disease in young children. Vaccine 2010, 28(31):4913-4919.
18. Ramet J., Weil-Olivier C., Sedlak W. Influenza vaccination: the paediatric perspective. Vaccine 2007, 25(5):780-787.
19. Szilagyi P.G., Iwane M.K., Schaffer S., Humiston S.G., Barth R., McInerny T., et al. Potential burden of universal influenza vaccination of young children on visits to primary care practices. Pediatrics 2003, 112(4):821-828.
20. Humiston S.G., Szilagyi P.G., Iwane M.K., Schaffer S.J., Santoli J., Shone L., et al. The feasibility of universal influenza vaccination for infants and toddlers. Arch Pediatr Adolesc Med 2004, 158(9):867-874.
21. Mereckiene J., Cotter S., D'Ancona F., Giambi C., Nicoll A., Lévy-Bruhl D., et al. Differences in national influenza vaccination policies across the European Union, Norway and Iceland 2008-2009. Euro Surveill 2010, 15(44).
22. Council of the European Union Council recommendation of 22 December 2009 on seasonal influenza vaccination (text with EEA relevance) (2009/1019/EU). Off J Eur Union 2009, L348/71.
23. Public Health Agency of Canada Statement on seasonal influenza for 2011-2012. Can Commun Dis Rep 2001, 37:ACS-5. Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-5/index-eng.php [accessed 28.08.12].
24. Esposito S., Montinaro V., Bosis S., Tagliabue C., Baggi E., Principi N. Recommendations for the use of influenza vaccine in pediatrics. Hum Vaccin Immunother 2012, 8(1).
25. Centers for Disease Control and Prevention Influenza vaccination coverage among children aged 6-23 months - United States, 2007-08 influenza season. MMWR 2009, 58(38):1063-1066.
26. Centers for Disease Control and Prevention. March flu vaccination coverage. Available at: [accessed 28.08.12]. http://www.cdc.gov/flu/professionals/vaccination/nfs-survey-march2012.htm.
27. Vaccine European New Integrated collaboration Effort II Consortium. Final report: seasonal influenza vaccination survey in EU/EAA, influenza season 2009-10; 2011. Available at: [accessed 28.08.12]. http://venice.cineca.org/Final_Seasonal_Influenza_Vaccination_Survey_2010.pdf.
28. Blank P.R., Schwenkglenks M., Szucs T.D. Vaccination coverage rates in eleven European countries during two consecutive influenza seasons. J Infect 2009, 58(6):446-458.
29. McMahon A.W., Iskander J., Haber P., Chang S., Woo E.J., Braun M.M., et al. Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003. Pediatrics 2005, 115(2):453-460.
30. Kunzi V., Dornseiff M., Horwath J., Hartmann K. Safe vaccination of children with a virosomal adjuvanted influenza vaccine. Vaccine 2009, 27(8):1261-1265.
31. Leroy Z., Broder K., Menschik D., Shimabukuro T., Martin D. Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system. Vaccine 2012, 30(11):2020-2023.
32. Hehme N.W., 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 Invest 2002, 22(11):751-769.
33. Petousis-Harris H., Poole T., Booy R., Turner N. Fever following administration of two inactivated influenza vaccines - a survey of parents of New Zealand infants and children 5 years of age and under. Vaccine 2011, 29(16):2933-2937.
34. Blyth C.C., Currie A.J., Wiertsema S.P., Conway N., Kirkham L.A., Fuery A., et al. Trivalent influenza vaccine and febrile adverse events in Australia, 2010: clinical features and potential mechanisms. Vaccine 2011, 29(32):5107-5113.
35. Mahajan D., Campbell-Lloyd S., Cook J., Menzies R.I. NSW annual report describing adverse events following immunisation, 2010. NSW Public Health Bull 2011, 22(9-10):196-208.
36. US Food and Drug Administration. Fluarix - influenza virus vaccine. Review of pre-licensure safety data. US Food and Drug Administration; 2012 [accessed 29.03.12].