Different influenza vaccine formulations and adjuvants for childhood influenza vaccination

Vaccine

Volumn 29, Issue 43, 2011, Pages 7535-7541

  Esposito, Susanna ^a   Principi, Nicola ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

Adjuvants; Children; Influenza; Influenza vaccination; Prevention; Vaccine formulations

Indexed keywords

AS 03; HEMAGGLUTINATION INHIBITING ANTIBODY; IMMUNOGLOBULIN A; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; MIFAMURTIDE; OVALBUMIN; SUBUNIT VACCINE; UNCLASSIFIED DRUG; VIROSOME VACCINE; VIRUS ANTIGEN; VIRUS HEMAGGLUTININ;

ANTIBODY PRODUCTION; ANTIBODY RESPONSE; ANTIBODY TITER; ASTHMA; B LYMPHOCYTE; CELL DIFFERENTIATION; CHILDHOOD DISEASE; CONGENITAL HEART DISEASE; CROSS REACTION; CYSTIC FIBROSIS; DENDRITIC CELL; DISEASE SEVERITY; DRUG EFFICACY; DRUG FEVER; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; EGG ALLERGY; GENOMIC INSTABILITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; INFLUENZA; INFLUENZA A; INFLUENZA B; INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H3N2; INJECTION SITE PAIN; LOCAL SKIN REACTION; LUNG DYSPLASIA; MONOCYTE; MUCOSAL IMMUNITY; NARCOLEPSY; NONHUMAN; PANDEMIC INFLUENZA; PRIORITY JOURNAL; REVIEW; SEROCONVERSION; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT; WHEEZING;

EID: 80053443019     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.08.012     Document Type: Article

References (86)

1. Glezen W.P. Emerging infections: pandemic influenza. Epidemiol Rev 1996, 18:64-76.
2. Neuzil K.M., Mellen B.G., Wright P.F., Mitchel E.F., Griffin M.R. The effect of influenza on hospitalization, outpatient visits, and courses of antibiotic use. N Engl J Med 2000, 342:225-231.
3. 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.
4. Centers for Disease Control and Prevention Prevention and control of influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2010, 59(RR-8):1-62.
5. European CDC. Seasonal influenza vaccines 2011. Available from. http://ecdc.europa.eu/en/healthtopics/seasonal_influenza/vaccines/Pages/influenza_vaccination.aspx.
6. Esposito S., Marchisio P., Principi N. The global state of influenza in children. Pediatr Infect Dis J 2008, 27(11 Suppl.):S149-S153.
7. Mereckiene J., Cotter S., D'Ancona F., Giambi C., Nicoll A., Levy-Bruhl D., et al. Differences in national influenza vaccination policies across the European Union, Norway and Iceland 2008-2009. Euro Surveill 2010, 15:pii19700.
8. Setse R.W., Euler G.L., Gonzalez-Feliciano A.G., Bryan L.N., Furlow C., Weinbaum C.M., et al. Centers for Disease Control and Prevention (CDC) Influenza vaccination coverage-United States, 2000-2010. MMWR Surveill Summ 2011, 60(Suppl.):38-41.
9. Esposito S., Marchisio P., Droghetti R., Lambertini L., Faelli N., Bosis S., et al. Influenza vaccination coverage among children with high-risk medical conditions. Vaccine 2006, 24:5251-5255.
10. Esposito S., Principi N. The rational use of influenza vaccines in healthy children and children with underlying conditions. Curr Opin Infect Dis 2009, 22:244-249.
11. Beyer W.E.P., Nauta J.J.P., Palache A.M., Giezeman K.M., Osterhaus A.D.M.E. Immunogenicity and safety of inactivated influenza vaccines in primed populations: a systematic literature review and meta-analysis. Vaccine 2011, [Epub May 30].
12. Walter E.B., Rajagopal S., Zhu Y., Neuzil K.M., Fairchok M.P., Englund J.A. Trivalent inactivated influenza vaccine (TIV) immunogenicity in children 6 through 23 months of age: do children of all ages respond equally?. Vaccine 2010, 28:4376-4383.
13. Zangwill K.M., Belshe R.B. Safety and efficacy of trivalent inactivated influenza vaccine in young children: a summary for the new era of routine vaccination. Pediatr Infect Dis J 2004, 23:189-200.
14. Gruber W.C., Taber L.H., Glezen P., Clover R.D., Abell T.D., Demmler R.W., et al. Live attenuated and inactivated influenza vaccine in school-age children. Am J Dis Child 1990, 144:595-600.
15. Hoberman A., Greenberg D.P., Paradise J.L., Rockette H.E., Lave J.R., Kearney D.H., et al. Efficacy of inactivated influenza vaccine in preventing acute otitis media (AOM) in children. JAMA 2003, 290:1608-1616.
16. Clover R.D., Crawford S., Glezen W.P., Taber L.H., Matson C.C., Couch R.B. Comparison of heterotypic protection against influenza A/Taiwan/86 (H1N1) by attenuated and inactivated vaccines to A/Chile/83-like viruses. J Infect Dis 1991, 163:300-304.
17. Heikkinen T., Ruuskanen O., Waris M., Ziegler T., Arola M., Halonen P. Influenza vaccination in the prevention of acute otitis media in children. Am J Dis Child 1991, 145:445-448.
18. Marchetti M., Kühnel U.M., Colombo G.L., Esposito S., Principi N. Cost-effectiveness of adjuvanted influenza vaccination of healthy children 6 to 60 months of age. Hum Vaccin 2007, 3:14-22.
19. Monto A.S., Davemport F.M., Napier J.A., Francis T. Modification of an outbreak of influenza in Tecumseh, Michigan by vaccination of schoolchildren. J Infect Dis 1970, 122:16-25.
20. 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, 344:889-896.
21. Neuzil K.M., Hohlbein C., Zhu Y. Illness among schoolchildren during influenza season: effect on school absenteeism, parental absenteeism from work, and secondary illness in families. Arch Pediatr Adolesc Med 2002, 156:986-991.
22. Shuler C.M., Iwamoto M., Bridges C.B., Marin M., Neeman R., Gargiullo P., et al. Vaccine effectiveness against medically attended, laboratory-confirmed influenza among children aged 6 to 59 months, 2003-2004. Pediatrics 2007, 119:e587-e595.
23. Jefferson T., Rivetti A., hardnen A., Di Pietrantonj C., Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev 2008, 2:CD004879.
24. Clements D.A., Langdon I., Bland C., Walter E., Influenza A vaccines decreases the incidence of otitis media in 6- to 30-month-old children in day care. Arch Pediatr Adolesc Med 1995, 149:1113-1117.
25. Piedra P.A., Glezen W.P. Influenza in children: epidemiology, immunity, and vaccines. Semin Pediatr Infect Dis 1991, 2:140-146.
26. Ruben F.L. Inactivated influenza virus vaccines in children. Clin Infect Dis 2004, 38:678-688.
27. Piedra P.A., Glezen W.P., Mbawuike I., Gruber W.C., Baxter B.D., Boland F.J., et al. Studies on reactogenicity and immunogenicity of attenuated bivalent cold recombinant influenza type A (CRA) and inactivates trivalent influenza virus (TI) vaccines in infants and young children. Vaccine 1993, 11:718-724.
28. Khan A.S., Polezhaev F., Vasiljeva R., Drinevsky V., Buffington J., Gary H., et al. Comparison of US inactivated split-virus and Russian live attenuated, cold adapted trivalent influenza vaccines in Russian school children. J Infect Dis 1996, 173:453-456.
29. Edwards K.M., Dupont W.D., Westrich M.K., Plummer W.D., Palmer P.S., Wright P.F. A randomized controlled trial of cold-adapted and inactivated vaccines for the prevention of influenza A disease. J Infect Dis 1994, 169:68-76.
30. Neuzil K.M., Dupont W.D., Wright P.F., Edwards K.M. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J 2001, 20:733-740.
31. Groothuis J.R., Levin M.J., Rabalais G.P., Meiklejohn G., Lauer B.A. Immunization of high-risk infants younger than 18 months of age with split product influenza vaccine. Pediatrics 1991, 87:823-828.
32. The safety of inactivated influenza vaccine in adults and children with asthma. N Engl J Med 2001, 345:1529-1536. American Lung Association Asthma Clinical Research Centers.
33. Chen R.T., DeStefano F., Davis R.L., Jackson L.A., Thompson R.S., Mullooly J.P., et al. The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA. Bull World Health Organ 2000, 78:186-194.
34. France E.K., Glanz J.M., Xu S., Davis R.L., Black S.B., Shinefield H.R., et al. Safety of the trivalent inactivated influenza vaccine among children: a population-based study. Arch Pediatr Adolesc Med 2004, 158:1031-1036.
35. Principi N., Esposito S., Marchisio P. Present and future of influenza prevention in pediatrics. Expert Opin Biol Ther 2011, 11:641-653.
36. Mischler R., Metcalfe I.C. Inflexal V, a trivalent virosome subunit influenza vaccine: production. Vaccine 2002, 20:B17-B23.
37. Huckriede A., Bungener I., Stegmann, Daemen T., Medema J., Palache A.M., et al. The virosomal concept for influenza vaccine. Vaccine 2005, 23:S26-S38.
38. Herzog C., Metcalfe I.C., Schaad U.B. Virosome influenza vaccine in children. Vaccine 2002, 20:B24-B28.
39. ® V-a virosomal adjuvanted influenza vaccine. Vaccine 2009, 27:4381-4387.
40. Kanra G., Marchisio P., Feiterna-Sperling C., Gaedicke G., Lazar H., Durrer P., et al. Comparison of immunogenicity and tolerability of a virosome-adjuvanted and a split influenza vaccine in children. Pediatr Infect Dis J 2004, 23:300-306.
41. 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, 28:6137-6144.
42. Tanzi E., Esposito S., Bojanin J., Amendola A., Trabattoni D., Pariani E., et al. Immunogenicity and effect of a virosomal influenza vaccine on viral replication and T-cell activation in HIV-infected children receiving highly active antiretroviral therapy. J Med Virol 2006, 78:440-445.
43. Viganò A., Zuccotti G.V., Pacei M., Erba P., Castelletti E., Giacomet V., et al. Humoral and cellular response to influenza vaccine in HIV-infected children with full viroimmunologic response to antiretroviral therapy. J Acquir Immune Defic Syndr 2008, 48:289-296.
44. Zuccotti G., Amendola A., Viganò A., Pariani E., Zappa A., Pogliani L., et al. Long term immunogenicity of a virosomal subunit inactivated influenza vaccine in children with asthma. Vaccine 2007, 25:6692-6698.
45. Zuccotti G.V., Scaramuzza A., Riboni S., Mameli C., Pariani E., Tanzi E., et al. Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus. Vaccine 2009, 27:5357-5362.
46. Schaad U.B., Bühlmann U., Burger R., Ruedeberg A., Wilder-Smith A., Rutishauser M. Comparison of immunogenicity and safety of a virosome influenza vaccine with those of a subunit influenza vaccine in pediatric patients with cystic fibrosis. Antimicrob Agents Chemother 2000, 44:1163-1167.
47. Salleras L., Domínguez A., Pumarola T., Prat A., Marcos M.A., Garrido P., et al. Effectiveness of virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3-14 years: a prospective cohort study. Vaccine 2006, 24:6638-6642.
48. Esposito S., Marchisio P., Bosis S., Lambertini L., Claut L., Faelli N., et al. Clinical and economic impact of influenza vaccination on healthy children aged 2-5 years. Vaccine 2006, 24:629-635.
49. Esposito S., Cecinati V., Scicchitano B., Delvecchio G.C., Santoro N., Amato D., et al. Impact of influenza-like illness and effectiveness of influenza vaccination in oncohematological children who have completed cancer therapy. Vaccine 2010, 28:1558-1565.
50. Calcagnile S., Zuccotti G.V. The virosomal adjuvanted influenza vaccine. Expert Opin Biol Ther 2010, 10:191-200.
51. Künzi V., Dornseiff M., Horwath J., Hartmann K. Safe vaccination of children with a virosomal adjuvanted influenza vaccine. Vaccine 2009, 27:1261-1265.
52. Zuccotti G.V., Cucchi C., Sala D., Giovannini M. Immunogenicity and safety of a virosomal influenza vaccine in HIV-infected children. Acta Paediatr 2002, 91:486.
53. Kürsteiner O., Moser C., Lazar H., Durrer P. Inflexal V-the influenza vaccine with the lowest ovalbumin content. Vaccine 2006, 24:6632-6635.
54. Esposito S., Gasparini C., Martelli A., Zenga A., Tremolati E., Varin E., et al. Safe administration of an inactivated virosomal adjuvanted influenza vaccine in asthmatic children with egg allergy. Vaccine 2008, 26:4664-4668.
55. O'Hagan D.T. MF59 is a safe and potent vaccine adjuvant that enhances protection against influenza virus infection. Expert Rev Vaccines 2007, 6:699-710.
56. Podda A., Del Giudice G. MF-59-adjuvanted vaccines: increased immunogenicity with an optimal safety profile. Expert Rev Vaccines 2003, 2:197-203.
57. Durando P., Icardi G., Ansaldi F. MF59-adjuvanted vaccine: a safe and useful tool to enhance and broaden protection against seasonal influenza viruses in subjects at risk. Expert Opin Biol Ther 2010, 10:639-651.
58. Iob A., Brianti G., Zamparo E., Gallo T. Evidence of increased clinical protection of an MF59-adjuvant influenza vaccine compared to a non-adjuvant vaccine among elderly residents of long-term care facilities in Italy. Epidemiol Infect 2005, 133:687-693.
59. Vesikari T., Pellegrini M., Karvonen A., Groth N., Borkowski A., O'Hagan D.T., et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J 2009, 28:563-571.
60. 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, 27:6291-6295.
61. Esposito S., D'Angelo E., Daleno C., Peia F., Scala A., Serra D., et al. Immunogenicity, safety and tolerability of monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in patients with β-thalassemia major. Vaccine 2010, 28:7825-7828.
62. Esposito S., Meregalli E., Daleno C., Ghio L., Tagliabue C., Valzano A., et al. An open-label, randomized clinical trial assessing immunogenicity, safety and tolerability of pandemic influenza A/H1N1 MF59-adjuvanted vaccine administered sequentially or simultaneously with seasonal virosomal-adjuvanted influenza vaccine to paediatric kidney transplant recipients. Nephrol Dial Transplant 2011, 26:2018-2024.
63. Esposito S., Selicorni A., Daleno C., Valzano A., Cerutti M., Galeone C., et al. Immunogenicity, safety and tolerability of monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children and adolescents with Williams or Cornelia De Lange syndrome. Hum Vaccin 2011, 7. [Epub June 1].
64. Esposito S., Pugni L., Daleno C., Ronchi A., Valzano A., Serra D., et al. Influenza A/H1N1 MF59-adjuvanted vaccine in preterm and term children aged 6 to 23 months. Pediatrics 2011, 127:e1161-e1168.
65. Schwarz T.F., Horacek T., Knuf M., Damman H.G., Roman F., Drame M., et al. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine 2009, 27:6284-6290.
66. Rumke H.C., Bayas J.M., de Juanes J.R., Caso C., Richardus J.H., Campins M., et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 2008, 26:2378-2388.
67. Chu D.W., Hwang S.J., Lim F.S., Oh H.M., Thongcharoen P., Yang P.C., et al. Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine. A phase III study in a large population of Asian adults. Vaccine 2009, 27:7428-7435.
68. Carmona A., Omeñaca F., Tejedor J.C., Merino J.M., Vaman T., Dieussaert I., et al. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine 2010, 28:5837-5844.
69. Garcia-Sicilia J., Gillard P., Carmona A., Tejedor J.C., Aristegui J., Merino J.M., et al. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine 2011, 29:4353-4361.
70. World Health Organization. Global Advisory Committee on Vaccine Safety: statement on narcolepsy and vaccination. Geneva: WHO. Available from 2011 [accessed 23.03.11]. http://www.who.intvaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_february2011/en/.
71. Skowronski D.M., Janjua N.Z., De Serres G., Hottes T.S., Dickinson J.A., Crowcroft N., et al. Effectiveness of AS03 adjuvanted pandemic H1N1 vaccine: case-control evaluation based on sentinel surveillance system in Canada, autumn 2009. BMJ 2011, 342:c7297.
72. Boyce T.G., Gruber W.C., Coleman-Dockery S.D., Sannella E.C., Reed G.W., Wolff M., et al. Mucosal immune response to trivalent live attenuated intranasal influenza vaccine in children. Vaccine 1999, 18:82-88.
73. Smith C.B., Purcell R.H., Bellanti J.A., Chanock R.M. Protective effect of antibody to parainfluenza type 1 virus. N Engl J Med 1966, 275:1145-1152.
74. Belshe R.B., Mendelman P.M., Treanor J., King J., Gruber W.C., Piedra P., et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine in children. N Engl J Med 1998, 338:1405-1412.
75. Belshe R.B., Gruber W.C., Mendelman P.M., Cho I., Reisinger K., Block S.L., et al. Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine. J Pediatr 2000, 136:168-175.
76. Tam J.S., Capeding M.R., Lum L.C., Chotpitayasunondh T., Jiang Z., Huang L.M., et al. Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia. Pediatr Infect Dis J 2007, 26:619-628.
77. Vesikari T., Fleming D.M., Aristegui J.F., Vertruyen A., Ashkenazi S., Rappaport R., et al. Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care. Pediatrics 2006, 118:2298-2312.
78. Bracco H., Farhat C.K., Tregnaghi M.W., Madhi S.A., Razmpour A., Palladino G., et al. Efficacy and safety of one and two doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J 2009, 28:365-371.
79. Forrest B.D., Pride M.W., Dunning A.J., Capeding M.R.Z., Chotpitayasunondh T., Tam J.S., et al. Correlation of cellular immune responses with protection against culture-confirmed influenza in young children. Clin Vaccine Immunol 2008, 15:1042-1053.
80. Rhorer J., Ambrose C.S., Dickinson S., Hamilton H.G., Oleka N.A., Malinoski F.J., et al. Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine 2009, 27:1101-1110.
81. 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, 118:2032-2037.
82. Belshe R.B., Edwards K.M., Vesikari T., Black S.V., Walker R.E., Hultquist M., et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 2007, 356:685-696. [Erratum in: N Engl J Med 2007;356:1283].
83. Ashkenazi S., Vertruyen A., Aristegui J., Esposito S., McKeith D.D., Klemola T., et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr Infect Dis J 2006, 25:870-879.
84. Fleming D., Crovari P., Wahn U., Klemola T., Schlesinger Y., Langussis A., et al. Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J 2006, 25:860-869.
85. Vesikari T., Karvonen A., Smith H.M., Dunning A., Razmpour A., Saville M.K., et al. Safety and tolerability of cold-adapted influenza vaccine, trivalent, in infants younger than 6 months of age. Pediatrics 2008, 121:e568-e573.
86. Gaglani M.J., Piedra P.A., Riggs M., Herschler G., Fewlass C., Glezen W.P. 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, 27:444-452.