A randomised, partially observerblind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart

Health Technology Assessment

Volumn 14, Issue 55, 2010, Pages 193-334

  Nicholson, K G ^a   Abrams, K R ^b   Batham, S ^a   Clark, T W ^a   Hoschler, K ^c   Lim, W S ^d   Medina, M ^a   Nguyen Van Tam, J S ^e   Read, R C ^f   Warren, F C ^b   Zambon, M ^c  

^a UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^b UNIVERSITY OF LEICESTER   (United Kingdom)

^c PUBLIC HEALTH ENGLAND   (United Kingdom)

^d NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^f UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE; VIRUS ANTIBODY; IMMUNOLOGICAL ADJUVANT; VIRUS VACCINE;

2009 H1N1 INFLUENZA; ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ABSCESS; ADULT; AGE DISTRIBUTION; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BACKACHE; CHEST TIGHTNESS; CHILL; COMMON COLD; CONFUSION; CONTROLLED CLINICAL TRIAL; COUGHING; DECREASED APPETITE; DELTOID MUSCLE; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSMENORRHEA; DYSPEPSIA; DYSPNEA; EAR INJURY; ECZEMA; EPIGASTRIC DISCOMFORT; FEMALE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HEMAGGLUTINATION INHIBITION TEST; HERPES LABIALIS; HUMAN; IMMUNOGENICITY; INFECTION; INFLUENZA VACCINATION; INJECTION SITE CONTUSION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; INJURY; INSOMNIA; LETHARGY; LIMB PAIN; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALAISE; MALE; MENTAL DISEASE; METABOLIC DISORDER; MIGRAINE; MOTION SICKNESS; MOUTH TEMPERATURE; MULTICENTER STUDY; MULTIPLE DRUG DOSE; MUSCLE STIFFNESS; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL PAIN; MYALGIA; NATIONAL HEALTH SERVICE; NAUSEA; NEUROLOGIC DISEASE; NOSE CONGESTION; NOSE IRRITATION; NUTRITIONAL DISORDER; OTALGIA; OUTCOME ASSESSMENT; PARALLEL DESIGN; PARESTHESIA; PHARYNGITIS; PROTECTION; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINORRHEA; RIGOR; SELF REPORT; SEROCONVERSION; SIDE EFFECT; SINGLE DRUG DOSE; SINUSITIS; SLEEP DISORDER; SNEEZING; SORE THROAT; SYSTEMIC DISEASE; TACHYPNEA; TOOTH PAIN; UNITED KINGDOM; VERTIGO; VIRUS NEUTRALIZATION; WOUND INFECTION; ADOLESCENT; AGED; ANALYSIS OF VARIANCE; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; EPIDEMIOLOGY; IMMUNOLOGY; INFLUENZA; INFLUENZA VIRUS A H1N1; ISOLATION AND PURIFICATION; MIDDLE AGED; MORTALITY; MULTIVARIATE ANALYSIS; PANDEMIC; PREVALENCE; RISK; STATISTICAL MODEL; STATISTICS;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; ANTIBODIES, VIRAL; CHI-SQUARE DISTRIBUTION; CONFIDENCE INTERVALS; CROSS-SECTIONAL STUDIES; FEMALE; GREAT BRITAIN; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; ODDS RATIO; PANDEMICS; PREVALENCE; SEROEPIDEMIOLOGIC STUDIES; VIRAL VACCINES; YOUNG ADULT;

EID: 79551554181     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta14550-04     Document Type: Article

References (100)

1. Potter CW. Chronicle of influenza pandemics. In KG Nicholson, RG Webster, AJ Hay, editors. Textbook of influenza. Oxford: Blackwell; 1998. pp. 3-18.
2. Kendal A P, Noble GR, Skehel JJ, Dowdle WR. Antigenic similarity of influenza A (H1N1) viruses from epidemics in 1977-1978 to 'Scandinavian' strains in epidemics of 1950-1951. Virology 1978:89:632-6.
3. World Health Organization. WHO global influenza preparedness plan. WHO/CDS/CSR/GIP/2005.5. WHO 2005. URL: www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_5.pdf (accessed 13 August 2010).
4. World Health Organization. Pandemic influenza preparedness and response. ISBN 978 92 4 154768 0. WHO 2009. URL: www.who.int/csr/disease/influenza/PIPGuidance09.pdf (accessed 13 August 2010).
5. Morens DM, Fauci AS. The 1918 influenza pandemic: insights for the 21st century. J Inf Dis 2007;195:1018-28.
6. Adams DL. Putting pandemics into perspective: England and the flu, 1889-1919. 2008. URL: http://kuscholarworks.ku.edu/dspace/bitstream/1808/4432/1/Adams_ku_0099D_10045_DATA_1.pdf (accessed 18 December 2010).
7. Reid A. The effects of the 1918-19 influenza pandemic on infant and child health in Derbyshire. Med Hist 2005;49:29-54.
8. Potter CW. A history of influenza. J Appl Microbiol 2001;91:572-9.
9. McDonald JC. Asian influenza in Great Britain 1957-58. Proc R Soc Med 1958;51:1016-18.
10. Anonymous. The influenza epidemic in England and Wales 1957-58. Reports on Public Health and Medical Subjects. No. 100. London: HMSO; 1960.
11. Chang WK. National influenza experience in Hong Kong, 1968. Bull WHO 1969;41:349-51.
12. Fukumi H. Summary report on Hong Kong influenza in Japan. Bull WHO 1969;41:3.53-9.
13. Roden AT. National experience with Hong Kong influenza in the United Kingdom, 1968-69. Bull WHO 1969;41:375-80.
14. Fleming DM, Elliot AJ. Lessons from 40 years' surveillance of influenza in England and Wales. Epidemiol Infect 2008;136:866-75.
15. Nguyen-Van-Tam JS. Epidemiology of influenza. In KG Nicholson, RG Webster, AJ Hay, editors. Textbook of influenza. London: Blackwell Science; 1998. pp. 181-216.
16. Nichol KL, Mendelman PM, Mallon KP, Jackson LA, Gorse GJ, Belshe RB, et al. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults. JAMA 1999;282:137-44.
17. Nicholson KG. Human influenza. In KG Nicholson, RG Webster, AJ Hay, editors. Textbook of influenza. London: Blackwell Science; 1998. pp. 219-64.
18. Smith AP, Thomas M, Brockman P, Kent J, Nicholson KG. Effect of influenza B infection on human performance. BMJ 1993;306:760-1.
19. Sullivan KM, Monto AS, Longini IM. Estimates of the US health impact of influenza. Am J Publ Hlth 1993;83:1712-16.
20. Nicholson KG, Kent J, Hammersley V, Cancio E. Acute viral infections of upper respiratory tract in elderly people living in the community: comparative, prospective, population based study of disease burden. BMJ 1997;315:1060-4.
21. Yassi A, Kettner J, Hammond G, Cheang M, McGill M. Effectiveness and cost-benefit of an influenza vaccination program for health care workers. Can J Inf Dis 1991;2:101-8.
22. Kumpulainen V, Makela M. Influenza vaccination among healthy employees: a cost-benefit analysis. Scand J Inf Dis 1997;29:181-5.
23. Keech M, Scott AJ, Ryan PJ. The impact of influenza and influenza-like illness on productivity and healthcare resource utilization in a working population. Occ Med 1998;48:85-90.
24. Monto AS, Sullivan KM. Acute respiratory illness in the community. Frequency of illness and the agents involved. Epidemiol Infect 1993:110:145-60.
25. Vutuc C, Kunze M. Influenza: incidence and costs of inpatient treatment. MMW Fortschr Med 1993;111:508-9.
26. Connolly AM, Salmon RL, Williams DH. What are the complications of influenza and can they be prevented? Experience from the 1989 epidemic of H3N2 influenza A in general practice. BMJ 1993;306:1452-4.
27. Fleming DM. The impact of three influenza epidemics on primary care in England and Wales. PharmacoEconomics 1996;9(Suppl. 3):38-45.
28. Neuzil KM, Reed GW, Mitchel EF, Griffin MR. Influenza-associated morbidity and mortality in young and middle-aged women. JAMA 1999;281:901-7.
29. Ahmed AH, Nicholson KG, Nguyen-Van-Tam JS, Pearson JCG. Effectiveness of influenza vaccine in reducing hospital admissions during the 1989-90 epidemic. Epidemiol Infect 1997;18:27-33.
30. Colquhoun AJ, Nicholson KG, Botha JL, Raymond NT. Effectiveness of influenza vaccine in reducing hospital admissions in people with diabetes. Epidemiol Infect 1997;119:335-41.
31. World Health Organization. Ten concerns if avian influenza becomes a pandemic. 14 October 2005. URL: www.who.int/csr/disease/influenza/pandemic10things/en/ (accessed 16 August 2010).
32. Rice GW, Palmer E. Pandemic influenza in Japan, mortality patterns and official responses. J Jap Stud 1993;19:389-420.
33. Myers KP, Olsen CW, Gray GC. Cases of swine influenza in humans a review of the literature. Clin Infect Dis 2007;44:1084-8.
34. Hodder RA, Gaydos JC, Allen RG, Top FH Jr, Nowosiwsky T, Russell PK, et al. Influenza A/swine at Fort Dix, NJ (Jan-Feb 1976), III. Extent of Spread and Duration of the Outbreak. J Infect Dis 1977;136(Suppl.):369-75.
35. Sencer DJ, Millar JD. Reflections on the 1976 swine flu vaccination program. Emerg Infect Dis 2006;12:29-33.
36. Echevarria-Zuno S, Mejia-Arangure JM, Mar-Obeso AJ, Grajales-Muñiz C, Robles-Pérez E, González-León M, et al. Infection and death from influenza A H1N1 virus in Mexico: a retrospective analysis. Lancet 2009;374:2072-9.
37. Perez-Padilla R, de la Rosa-Zamboni D, Ponce de Leon S, Hernandez M, Quiñones-Falconi F, Bautista E, et al. Pneumonia and respiratory failure from swine-origin influenza A (H1N1) in Mexico. N Engl J Med 2009;361:680-9.
38. Ginsberg M, Hopkins J, Maroufi A, Dunne G, Sunega DR, Giessick J, et al. Swine influenza A (H1N1) infection in two children: Southern California, March-April 2009. Morb Mortal Wkly Rep 2009;58:400-2.
39. Dawood FS, Jain S, Lyn Finelli PH, Shaw MW, Lindstrom S, Garten RJ, et al. 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;360:2605-15.
40. Chan M. World now at the start of 2009 influenza pandemic. URL: www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html (accessed 16 August 2010).
41. Garten RJ, Davis CT, Russell CA, Shu B, Lindstrom S, Balish A, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009;325:197-201.
42. Anonymous. Recommended composition of influenza virus vaccines for use in the 2010 influenza season (southern hemisphere winter). Wkly Epidemiol Rec 2009;84:421-31.
43. Katz J, Hancock K, Veguilla V, Zhong W, Lu XH, Sun H. Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. Morb Mortal Wkly Rep 2009;58;521-4. URL: www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm (accessed 16 August 2010).
44. Update on oseltamivir-resistant pandemic A (H1N1) 2009 influenza virus: January 2010. Wkly Epidemiol Rec 2010;85:37-40.
45. Baz M, Abed Y, Papenburg J, Bouhy X, Hamelin M-E, Boivin G. Emergence of oseltamivirresistant pandemic H1N1 virus during prophylaxis. N Engl J Med 2009;361:2296-7.
46. Meiklejohn G, Eickhoff TC, Graves P. Antigenic drift and efficacy of influenza virus vaccines, 1976-1977. J Infect Dis 1978;138:618-24.
47. De Donato S, Granoff D, Minutello M, Lecchi G, Faccini M, Agnello M, et al. Safety and immunogenicity of MF59-adjuvanted influenza vaccine in the elderly. Vaccine 1999;17:3094-101.
48. US Census Bureau. URL: www.census.gov/ipc/www/popclockworld.html (accessed 16 August 2010).
49. Kieny M-P. WHO Briefing on H1N1 vaccines. 19 May 2009. URL: www.who.int/vaccine_research/H1N1vaccines.pdf (accessed 16 August 2010).
50. Lermann SJ. Reactogenicity and immunogenicity of monovalent A/New Jersey/76 influenza virus vaccines in children. J Infect Dis 1977:136(Suppl.): 563-70.
51. Nicholson KG, Tyrrell DAJ, Harrison, Potter CW, Jennings. R, Clark A, et al. Clinical studies of monovalent whole virus and subunit A/USSR/77 (H1N1) vaccine: serological responses and clinical reactions. J Biol Stand 1979;7:123-36.
52. Treanor JJ, Wilkinson BE, Masseoud F, Hu-Primmer J, Battaglia R, O'Brien D, et al. Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans. Vaccine 2001;19:1732-7.
53. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M, et al. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006;354:1343-51.
54. Nicholson KG, Colegate AE, Podda A, Stephenson I, Wood J, Ypma E, et al. Safety and antigenicity of non-adjuvanted and MF59- adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet 2001;357:1937-43.
55. Bresson J-L, Perronne C, Launay O, Gerdil C, Saville M, Wood J, et al. Safety and immunogenicity of an inactivated split-virion influenza A/ Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006;367:1657-64.
56. Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, et al. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine 2008;26:4160-7.
57. Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, et al. Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial. J Infect Dis 2008;198:1309-16.
58. Stephenson I, Nicholson KG, Glück R, Mischler R, Newman RW, Palache AM, et al. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 2003;362:1959-66.
59. Cox RJ, Madhun AS, Hauge S, Sjursen H, Major D, Kuhne M, et al. A phase I clinical trial of a PER. C6 cell grown influenza H7 virus vaccine. Vaccine 2009;27:1889-97.
60. Ehrlich HJ, Müller M, Oh HML, Tambyah PA, Joukhadar C, Montomoli E, et al. A clinical trial of whole-virus H5N1 vaccine derived from cell culture. N Engl J Med 2008;358:2573-84.
61. Stephenson I, Nicholson KG, Colegate A, Podda A, Wood J, Ypma E, et al. Boosting immunity to influenza H5N1 with MF59-adjuvanted H5N3 A/ Duck/Singapore/97 vaccine in a primed human population. Vaccine 2003;21:1687-93.
62. Stephenson I, Bugarini R, Nicholson KG, Podda A, Wood JM, Zambon MC, 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;191:1210-15.
63. Stephenson I, Nicholson KG, Hoschler K, Zambon MC, Hancock K, DeVos J, et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. N Engl J Med 2008;359:1631-3.
64. Galli G, Hancock K, Hoschler K, DeVos J, Praus M, Bardelli M, 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 USA 2009;106:7962-7.
65. 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: a randomised controlled trial. Lancet 2007;370:580-9.
66. Leroux-Roels I, Bernhard R, Gérard P, Dramé M, Hanon E, Leroux-Roels G, et al. Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One 2008;3:e1665.
67. Levie K, Leroux-Roels I, Hoppenbrouwers K. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis 2008;198:642-9.
68. Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006;368:991-7.
69. European Committee for Proprietary Medicinal Products. Note for guidance on harmonization of requirements for influenza vaccines. September 1996: CPMP/BWP/214/96. Circulaire No 96-0666:1-22. 12 March 1997. URL: www.emea.europa.eu/pdfs/human/bwp/021496en.pdf (accessed 16 August 2010).
70. Committee for Proprietary Medicinal Products. Guideline on dossier structure and content for pandemic vaccine marketing authorisation. London 5 April 2004, CPMP/VEG/4717/03. http://archives.who.int/prioritymeds/report/append/62EMEAguidelines.pdf (accessed 16 August 2010).
71. Stephenson I, Das RG, Wood JM, Katz JM. Comparison of neutralising antibody assays for detection of antibody to influenza A/H3N2 viruses: an international collaborative study. Vaccine 2007;25:4056-63.
72. Wood JM, Gaines-Das RE, Taylor J, Chakraverty P. Comparison of influenza serological techniques by international collaborative study. Vaccine 1994;12:167-74.
73. Wood J. Update on development of International Standards for H5N1 antibodies. WHO meeting on evaluation of pandemic influenza prototype vaccines in clinical trial, WHO, Geneva, 12-13 February 2009. URL: www.who.int/vaccine_research/diseases/influenza/120209_John_Wood.pdf (accessed 16 August 2010).
74. The 5th WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, 12-13 February 2009, Geneva. URL: www.who.int/vaccine_research/diseases/influenza/meeting_120209/en/ (accessed 16 August 2009).
75. 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.
76. 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. URL: www.biomedcentral.com/1471-2288/10/18.
77. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. Center for Biologics Evaluation and Research. May 2007. URL: www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091985.pdf (accessed 16 August 2009).
78. Stephenson I, Heath A, Major D, Newman RW, Hoschler K, Junzi W, et al. Reproducibility of serologic assays for influenza virus A (H5N1). Emerg Infect Dis 2009;15:1252-9.
79. Rowe T, Abernathy RA, Hu-Primmer J, Thompson WW, Lu X, Lim W, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999;37:937-43.
80. Ellis JS, Zambon MC. Molecular investigation of an outbreak of influenza in the United Kingdom. Eur J Epidemiol 1997;13:369-72.
81. International Conference on Harmonisation/ Good Clinical Practice. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice, E6(r1). 10 June 1996. URL: www.scribd.com/doc/14677530/ICH-GCP-Guidelines (accessed 18 December 2010).
82. Bautista E, Chotpitayasunondh T, Gao Z, Harper SA, Shaw M, Uyeki TM, et al. Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza. Clinical Aspects of Pandemic 2009 Influenza A (H1N1) Virus Infection. N Engl J Med 2010;362:1708-19.
83. European Medicines Agency. Twenty-second pandemic pharmacovigilance update. 2010. URL: www.ema.europa.eu/influenza/updates.html (accessed 17 September 2010).
84. Hancock K, Veguilla V, Xiuhua L, Zhong W, Butler EN, Sun H, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009;361:1945-52.
85. 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;375:1100-8.
86. Reed C, Angulo FJ, Swerdlow DL, Lipsitch M, Meltzer MI, Jernigan D, et al. Estimates of the prevalence of pandemic (H1N1) 2009, United States, April-July 2009. Emerg Infect Dis 2009;15:2004-7.
87. Donaldson LJ, Rutter PD, Ellis BM, Greaves FEC, Mytton OT, Pebody RG, et al. Mortality from pandemic A/H1N1 2009 influenza in England: public health surveillance study. BMJ 2009;339:b5213.
88. Vesikari T, Pellegrini M, Karvonen A, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis 2009;28:563-71.
89. Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, et al. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza H9N2 vaccine preparations. Clin Infect Dis 2006;43:1135-42.
90. Frey S, Poland G, Percell S, Podda A, et al. Comparison of the safety, tolerability and immunogenicity of MF59-adjuvanted and nonadjuvanted influenza vaccine in non-elderly adults. Vaccine 2003;21:4234-37.
91. Waddington CS, Oeser C, Reiner A, John T, Wilkins S, Casey M, et al. Safety and immunogenicity of AS03B adjuvanted split virion versus nonadjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ 2010;340:c2649 doi:10.1136/bmj.c2649.
92. Arguedas A, Soley C, Lindert K. Responses to 2009 H1N1 vaccine in children 3 to 17 years of age. N Engl J Med 2010;362:370-2.
93. Clark TW, Pareek M, Hoschler K, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009;361:2424-35.
94. Greenberg ME, Lai MH, Hartel GF, et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 2009;361:2405-13.
95. Liang X-F, Wang H-Q, Wang J-Z, Fang H-H, Wu J, Zhu F-C, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebocontrolled trial. Lancet 2010;375:56-66.
96. 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 2009;303:37-46.
97. Plennevaux E, Sheldon E, Blatter M, Reeves-Hochq MK, 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;375:41-8.
98. Roman F, Vaman T, Gerlach B, Markendorf A, Gillard P, Devaster JM. Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03Aadjuvant: Preliminary report of an observer-blind, randomised trial. Vaccine 2010;28:1740-5.
99. Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 2010;375:49-55.
100. Zhu FC, Wang H, Fang HH, Wang JG, Lin XJ, Liang XF, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med 2009;361:2414-23.