Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents

Vaccine

Volumn 29, Issue 26, 2011, Pages 4353-4361

  Garcia Sicilia, J ^a   Gillard, P ^b   Carmona, A ^c   Tejedor, J C ^d   Aristegui, J ^e   Merino, J M ^f   Behre, U ^g   Caplanusi, A ^b   Vaman, T ^h   Dieussaert, I ^b  

^a HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^b GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^c Instituto Hispalense de Pediatria   (Spain)

^d HOSPITAL DE MÓSTOLES   (Spain)

^e HOSPITAL DE BASURTO   (Spain)

^f HOSPITAL UNIVERSITARIO DE BURGOS   (Spain)

^g Paediatric Practice   (Germany)

^h GlaxoSmithKline Pharmaceuticals Ltd   (India)

Author keywords

AS03 adjuvant; Children; H1N1 pandemic vaccine

Indexed keywords

HEMAGGLUTININ; INFLUENZA VACCINE;

2009 H1N1 INFLUENZA; ADOLESCENT; ANTIBODY TITER; ARTICLE; CHILD; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; FEMALE; HEMAGGLUTINATION; HUMAN; IMMUNOGENICITY; MALE; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SEROCONVERSION;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ALPHA-TOCOPHEROL; ANTIBODIES, VIRAL; CHILD; DRUG COMBINATIONS; FEMALE; GERMANY; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; PANDEMICS; POLYSORBATES; SPAIN; SQUALENE; TREATMENT OUTCOME; VACCINATION;

EID: 79957824323     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.04.011     Document Type: Article

References (35)

1. Domínguez-Cherit G., Lapinsky S.E., Macias A.E., Pinto R., Espinosa-Perez L., de la Torre A., et al. Critically ill patients with 2009 influenza A (H1N1) in Mexico. JAMA 2009, 302:1880-1887.
2. Fraser C., Donnelly C.A., Cauchemez S., Hanage W.P., Van Kerkhove M.D., Hollingsworth T.D., et al. Pandemic potential of a strain of influenza A (H1N1): early findings. Science 2009, 324:1557-1561.
3. WHO Pandemic influenza A (H1N1) 2009 virus vaccine-conclusions and recommendations from the October 2009 meeting of the immunization Strategic Advisory Group of Experts. Wkly Epidemiol Rec 2009, 49:505-508.
4. WHO. Director-general statement following the eighth meeting of the Emergency Committee. 3 June 2010. Available from: [accessed 03.11.10]. http://www.who.int/csr/disease/swineflu/8th_meeting_ihr/en/index.html.
5. Waddington C.S., Walker W.T., Oeser C., Reiner A., John T., Wilkins S., et al. Safety and immunogenicity of AS03-adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ 2010, 340:c2649.
6. Jain S., Kamimoto L., Bramley A.M., Schmitz A.M., Benoit S.R., Louie J., et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med 2009, 361:1935-1944.
7. EDC Interim Guidance. Use of specific pandemic influenza vaccines during the H1N1 2009 pandemic. August 2009. Available from: [accessed 03.11.10]. http://www.ecdc.europa.eu/en/publications/Publications/0908_GUI_Pandemic_Influenza_Vaccines_during_the_H1N1_2009_Pandemic.pdf.
8. Nicoll A. A new decade, a new seasonal influenza: the Council of the European Union Recommendation on seasonal influenza vaccination. Euro Surveill 2010, 15:1-2.
9. Kumar A., Zarychanski R., Pinto R., Cook D.J., Marshall J., Lacroix J., et al. Critically ill patients with 2009 influenza A (H1N1) infection in Canada. JAMA 2009, 302:1872-1879.
10. Centers for Disease Control and Prevention (CDC) Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep 2009, 58 (RR-10):1-8.
11. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009, 360:2605-2615.
12. Miller E., Hoschler K., Hardelid P., Stanford E., Andrews N., Zambon M. Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet 2010, 375:1100-1108.
13. Roman F., Vaman T., Gerlach B., Markendorf A., Gillard P., Devaster J.M. Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: preliminary report of an observer-blind, randomised trial. Vaccine 2010, 28:1740-1745.
14. Hancock K., Veguilla V., Lu X., Zhong W., Butler E.N., Sun H., et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009, 361:1945-1952.
15. Clark T.W., Pareek M., Hoschler K., Dillon H., Nicholson K.G., Groth N., et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009, 361:2424-2435.
16. Basta N.E., Chao D.L., Halloran M.E., Matrajt L., Longini I.M. Strategies for pandemic and seasonal influenza vaccination of schoolchildren in the United States. Am J Epidemiol 2009, 170:679-686.
17. Fiore A.E., Neuzil K.M. 2009 influenza A (H1N1) monovalent vaccines for children. JAMA 2010, 303:73-74.
18. Nolan T., McVernon J., Skeljo M., Richmond P., Wadia U., Lambert S., et al. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants and children: a randomized trial. JAMA 2010, 303:37-46.
19. Jordan R., Connock M., Albon E., Fry-Smith A., Olowokure B., Hawker J., et al. Universal vaccination of children against influenza: are there indirect benefits to the community? A systematic review of the evidence. Vaccine 2006, 24:1047-1062.
20. Nichol K.L. Efficacy and effectiveness of influenza vaccination. Vaccine 2008, 26:D17-22.
21. Loeb M., Russell M.L., Moss L., Fonseca K., Fox J., Earn D.J.D., et al. Effect of influenza vaccination of children on infection rates in Hutterite communities. JAMA 2010, 303:943-950.
22. Díez-Domingo J., Garcés-Sanchez M., Baldó J.M., Planelles M.V., Ubeda I., JuBert A., et al. Immunogenicity and safety of H5N1 A/Vietnam/1194/2004 (clade 1) AS03-adjuvanted pre-pandemic candidate influenza vaccines in children aged 3 to 9 years: a phase II, randomized, open, controlled study. Pediatr Infect Dis J 2010, 29:1-12.
23. EMA pandemic influenza (H1N1) website. Vaccines. February 2010. Available from: [accessed 03.11.10]. http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/special_topics/general/general_content_000251.jsp%26mid=WC0b01ac058004b9ac%26murl=menus/special_topics/special_topics.jsp%26jsenabled=true.
24. Leroux-Roels I., Borkowski A., Vanwolleghem T., Dramé M., Clement F., Hons E., et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine. Lancet 2007, 370:580-589.
25. EMA. European medicines agency reaffirms efficacy and safety of H1N1 pandemic vaccines. November 2009. Available from: [accessed 03.11.10]. http://www.ema.europa.eu/pdfs/human/press/pr/74870709en.pdf.
26. Hehme N.W., Künzel W., Petschke F., Turk G., Raderecht C., Van Hoecke C., et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Invest 2002, 22:751-769.
27. Van Buynder P.G., Dhaliwal J.K., Van Buynder J.L., Couturier C., Minville-LeBlanc M., Garceau R., et al. Protective effect of single-dose adjuvanted pandemic influenza vaccine in children. Influenza Other Respi Viruses 2010, 4:171-178.
28. Schwarz T.F., Horacek T., Knuf M., Damman H.G., Roman F., Dramé 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.
29. Nolan T., McVernon J., Skeljo M., Richmond P., Wadia U., Lambert S., et al. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants and children. JAMA 2010, 303:37-46.
30. National Institute of Allergy and Infectious Disease. Updated results: in youngest children, a second dose of 2009 H1N1 influenza vaccine elicits robust immune response. November 2009. Available from: [accessed 03.11.10]. http://www.niaid.nih.gov/news/newsreleases/2009/Pages/interimpedsdata.aspx.
31. Plennevaux E., Sheldon E., Blatter M., Reeves-Hoché M.K., 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, 375:41-48.
32. 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.
33. Zhu F.-C., Wang H., Fang H.-H., Yang J.G., Lin X.J., Liang X.-F., et al. A novel Influenza A (H1N1) vaccine in various age groups. N Engl J Med 2009, 361:2414-2423.
34. Rümke 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.
35. de Aristegui Fernandez J., Cos Arregui B., Zurimendi Carril A., Alday Esteban V., Alzua Ruiz J., De la Fuente Jausoro E., et al. Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar®) administered in previously unvaccinated Spanish children aged 24 to 36 months. Vaccine 2005, 23:1917-1922.