Dose-range Study of MF59-adjuvanted Versus Nonadjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in Six- to Less Than Thirty-Six-month-old Children

Pediatric Infectious Disease Journal

Volumn 31, Issue 7, 2012, Pages e92-e98

  Block, Stan L ^a   Ruiz Palacios, Guillermo M ^a   Guerrero, M Lourdes ^a   Beygo, Jenny ^a   Sales, Victor ^a   Holmes, Sandra J ^a  

^a Kentucky Pediatric Research Institute   (United States)

Author keywords

Adjuvant; H1N1; Influenza; MF59; Pandemic; Pediatric

Indexed keywords

INFLUENZA VACCINE; MIFAMURTIDE;

2009 H1N1 INFLUENZA; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CHILD; CONTROLLED STUDY; DIARRHEA; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; EATING DISORDER; ECCHYMOSIS; ERYTHEMA; FEMALE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; IMMUNOGENICITY; INFANT; INJECTION SITE INDURATION; INJECTION SITE REACTION; IRRITABILITY; MALE; MULTICENTER STUDY; NORMAL HUMAN; PANDEMIC INFLUENZA; PATHOLOGICAL CRYING; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SIDE EFFECT; SOMNOLENCE; SWELLING; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ANTIBODIES, VIRAL; CHILD, PRESCHOOL; DRUG TOXICITY; EUROPEAN UNION; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; POLYSORBATES; SQUALENE; UNITED STATES;

EID: 84862765251     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e318257644f     Document Type: Article

References (32)

1. Cohen J. Swine flu pandemic. What’s old is new: 1918 virus matches 2009 H1N1 strain. Science. 2010;327:1563-1564
2. Sachedina N, Donaldson LJ. Paediatric mortality related to pandemic influenza A H1N1 infection in England: an observational population-based study. Lancet. 2010;376:1846-1852
3. Health Protection Agency. Pandemic (H1N1) 2009 in England: an overview of initial epidemiological findings and implications for the second wave. Available at: http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1258560552857. Accessed September 6, 2011.
4. Miller E, Hoschler K, Hardelid P, et al. Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet. 2010;375:1100-1108
5. New influenzaA (H1N1) virus: global epidemiological situation, June 2009 Wkly Epidemiol Rec. 2009;84:249-257
6. Strategic Advisory Group of Experts on Immunization. Report of the Extraordinary meeting on the influenza A (H1N1) 2009 pandemic, 7 July 2009. Available at: http://www.who.int/wer/2009/wer8430.pdf. Accessed September 6, 2011
7. Glezen WP, Couch RB. Interpandemic influenza in the Houston area, 1974-76. N Engl J Med. 1978;298:587-592
8. Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 MMWR Recomm Rep. 2009;58:1-8
9. Basta NE, Chao DL, Halloran ME, et al. Strategies for pandemic and seasonal influenza vaccination of schoolchildren in the United States. Am J Epidemiol. 2009;170:679-686
10. Medlock J, Galvani AP. Optimizing influenza vaccine distribution. Science. 2009;325:1705-1708
11. Yang Y, Sugimoto JD, Halloran ME, et al. The transmissibility and control of pandemic influenza A (H1N1) virus. Science. 2009;326:729-733
12. Jordan R, Connock M, Albon E, 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
13. Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR Morb Mortal Wkly Rep. 2009;58:521-524
14. Kelly H, Mercer G, Cheng A. Quantifying the risk of pandemic influenza in pregnancy and indigenous people in Australia in 2009. Euro Surveill. 2009;14:pii=19441 Available at: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19441. Accessed September 5, 2011.
15. World Health Organization. Global alert and response: WHO recommendations on pandemic (H1N1) 2009 vaccines. 2009 Geneva Available at: http://www.who.int/csr/disease/swineflu/notes/h1n1_vaccine_20090713/en/index.html. Accessed September 5, 2011.
16. Tsai TF, Crucitti A, Nacci P, et al. Explorations of clinical trials and pharmacovigilance databases of MF59®-adjuvanted influenza vaccines for associated cases of narcolepsy. Scand J Infect Dis. 2011;43:702-706
17. Podda A, Del Giudice G. MF59-adjuvanted vaccines: increased immunogenicity with an optimal safety profile. Expert Rev Vaccines. 2003;2:197-203
18. World Health Organization. Availability of a candidate reassortant vaccine virus for the novel influenza A (H1N1) vaccine development X-179A. Available at: http://www.who.int/csr/resources/publications/swineflu/candidates_X-179a/en/. Accessed September 5, 2011
19. Stephenson I, Nicholson KG, Wood JM, et al. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis. 2004;4:499-509
20. Plennevaux E, Sheldon E, Blatter M, et al. 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
21. Clark TW, Pareek M, Hoschler K, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009;361:2424-2435
22. Oh CE, Lee J, Kang JH, et al. Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial. Vaccine. 2010;28:5857-5863
23. Waddington CS, Walker WT, Oeser C, et al. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ. 2010;340:c2649
24. Carmona A, Omeñaca F, Tejedor JC, et al. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010;28:5837-5844
25. Banzhoff A, Gasparini R, Laghi-Pasini F, et al. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS ONE. 2009;4:e4384
26. Bernstein DI, Edwards KM, Dekker CL, et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis. 2008;197:667-675
27. Galli G, Hancock K, Hoschler K, et al. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A. 2009;106:7962-7967
28. Vesikari T, Pellegrini M, Karvonen A, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009;28:563-571
29. Stephenson I, Bugarini R, Nicholson KG, et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J Infect Dis. 2005;191:1210-1215
30. Stephenson I, Nicholson KG, Hoschler K, et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. N Engl J Med. 2008;359:1631-1633
31. Vesikari T, Groth N, Karvonen A, et al. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine. 2009;27:6291-6295
32. Galli G, Medini D, Borgogni E, et al. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009;106:3877-3882