Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: A randomized, controlled trial in adults

BMC Infectious Diseases

Volumn 13, Issue 1, 2013, Pages

  Beran, Jiří ^a,b   Peeters, Mathieu ^c   Dewé, Walthère ^c   Raupachová, Jolana ^a   Hobzová, Lenka ^a   Devaster, Jeanne Marie ^c  

^a The Vaccination and Travel Medicine Center   (Czech Republic)

^b UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^c GSK   (Belgium)

Author keywords

Adjuvant; Influenza vaccine; Quadrivalent; Tetravalent; Trivalent inactivated

Indexed keywords

HEMAGGLUTININ; INFLUENZA VACCINE;

ADULT; ARTICLE; CONTROLLED STUDY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INFLUENZA A (H1N1); INFLUENZA A (H3N2); INFLUENZA VACCINATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE REDNESS; INJECTION SITE SWELLING; LOW DRUG DOSE; MALE; MYALGIA; NAUSEA; NONHUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SHIVERING; SINGLE BLIND PROCEDURE;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; ANTIBODIES, VIRAL; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NEUTRALIZATION TESTS;

EID: 84877841776     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/1471-2334-13-224     Document Type: Article

References (46)

1. Stöhr K. Influenza-WHO cares. Lancet Infect Dis 2002, 2:517. 10.1016/S1473-3099(02)00366-3, 12206966.
2. Barr IG, Komadina N, Durrant C, Sjogren H, Hurt AC, Shaw RP. Circulation and antigenic drift in human influenza B viruses in SE Asia and Oceania since 2000. Commun Dis Intell 2006, 30:350-357.
3. Rota PA, Wallis TR, Harmon MW, Rota JS, Kendal AP, Nerome K. Cocirculation of two distinct evolutionary lineages of influenza type B virus since 1983. Virology 1990, 175:59-68. 10.1016/0042-6822(90)90186-U, 2309452.
4. Li WC, Shih SR, Huang YC, Chen GW, Chang SC, Hsiao MJ, Tsao KC, Lin TY. Clinical and genetic characterization of severe influenza B-associated diseases during an outbreak in Taiwan. J Clin Virol 2008, 42:45-51. 10.1016/j.jcv.2007.11.026, 18325832.
5. McCullers JA, Saito T, Iverson AR. Multiple Genotypes of Influenza B Virus Circulated between 1979 and 2003. J Virol 2004, 78:12817-12828. 10.1128/JVI.78.23.12817-12828.2004, 525012, 15542634.
6. Belshe RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine 2010, 28:D45-D53.
7. Couch RB. Background and Presentation of Possible Vaccine Options. Vaccines and Related Biological Products Advisory Committee (VRBPAC), Food and Drug Administration, Topic 4: Influenza Type B Strain - Discussion on Circulating Lineages 2007, http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4282S2-00-index.htm.
8. Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality Associated With Influenza and Respiratory Syncytial Virus in the United States. JAMA 2003, 289:179-186. 10.1001/jama.289.2.179, 12517228.
9. World Health Organization Recommended viruses for influenza vaccines for use in the 2010-2011 Northern Hemisphere influenza season http://www.who.int/influenza/vaccines/virus/recommendations/201002_Recommendation.pdf, 3547786, 23289789, World Health Organization.
10. US Centers for Disease Control and Prevention (CDC) Seasonal influenza activity surveillance reports: 1999-2000 to 2010-2011 seasons http://www.cdc.gov/flu/weekly/pastreports.htm, US Centers for Disease Control and Prevention (CDC).
11. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother 2012, 8:1-8. 10.4161/hv.8.1.19091, 22251991.
12. Jefferson T, Di PC, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2010, 7:CD001269. 10.1002/14651858.CD001269.pub4, 20614424.
13. Belshe RB, Coelingh K, Ambrose CS, Woo JC, Wu X. Efficacy of live attenuated influenza vaccine in children against influenza B viruses by lineage and antigenic similarity. Vaccine 2010, 28:2149-2156. 10.1016/j.vaccine.2009.11.068, 20003926.
14. Jackson L, Gaglani M, Keyserling H, Balser J, Bouveret N, Fries L, Treanor J. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis 2010, 10:71. 10.1186/1471-2334-10-71, 2845585, 20236548.
15. Beran J, Wertzova V, Honegr K, Kaliskova E, Havlickova M, Havlik J, Jirincova H, Van BP, Jain V, Innis B, Devaster JM. Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example. BMC Infect Dis 2009, 9:2. 10.1186/1471-2334-9-2, 2639595, 19149900.
16. Heckler R, Baillot A, Engelmann H, Neumeier E, Windorfer A. Cross-protection against homologous drift variants of influenza A and B after vaccination with split vaccine. Intervirology 2007, 50:58-62. 10.1159/000096314, 17164559.
17. Levandowski RA, Regnery HL, Staton E, Burgess BG, Williams MS, Groothuis JR. Antibody responses to influenza B viruses in immunologically unprimed children. Pediatrics 1991, 88:1031-1036.
18. Englund JA, Walter EB, Gbadebo A, Monto AS, Zhu Y, Neuzil KM. Immunization with trivalent inactivated influenza vaccine in partially immunized toddlers. Pediatrics 2006, 118:e579-e585. 10.1542/peds.2006-0201, 16950949.
19. World Health Organization (WHO). Recommended composition of influenza virus vaccines for use in the 2012-2013 northern hemisphere influenza season http://www.who.int/influenza/vaccines/virus/recommendations/201202_recommendation.pdf, .
20. Garçon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines: concepts, achievements and perspectives. Expert Rev Vaccines 2007, 6:723-739. 10.1586/14760584.6.5.723, 17931153.
21. Leroux-Roels I, Borkowski A, Vanwolleghem T, Drame M, Clement F, Hons E, Devaster JM, Leroux-Roels G. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007, 370:580-589. 10.1016/S0140-6736(07)61297-5, 17707753.
22. World Health Organization (WHO) Recommended composition of influenza virus vaccine for use in the 2007-2008 influenza season http://www.who.int/wer/2007/wer8209.pdf, World Health Organization (WHO).
23. Hehme NW, Künzel W, Petschke F, Türk G, Raderecht C, Van Hoecke C, Sänger R. Ten Years of Experience with the Trivalent Split-Influenza Vaccine, Fluarix(TM). Clin Drug Investig 2002, 22:751-769.
24. Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. Food and Drug Administration (FDA) http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091990.pdf.
25. Committee for Proprietary Medicinal Products (CPMP) Note for guidance on harmonisation of requirements for influenza vaccines. The European Agency for the Evaluation of Medicinal Products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf, Committee for Proprietary Medicinal Products (CPMP).
26. Hehme N, Engelmann H, Kuenzel W, Neumeier E, Saenger R. Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use. Virus Res 2004, 103:163-171. 10.1016/j.virusres.2004.02.029, 15163505.
27. Rowe T, Abernathy RA, Hu-Primmer J, Thompson WW, Lu X, Lim W, Fukuda K, Cox NJ, Katz JM. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999, 37:937-943. 88628, 10074505.
28. Reed LJ, Muench H. A simple method of estimating fifty per cent endpoints. Am J Hyg 1938, 27:493-497.
29. Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, Iskander JK, Wortley PM, Shay DK, Bresee JS, Cox NJ. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep 2010, 59:1-62.
30. Camilloni B, Neri M, Lepri E, Iorio AM. Cross-reactive antibodies in middle-aged and elderly volunteers after MF59-adjuvanted subunit trivalent influenza vaccine against B viruses of the B/Victoria or B/Yamagata lineages. Vaccine 2009, 27:4099-4103. 10.1016/j.vaccine.2009.04.078, 19410623.
31. Block SL, Falloon J, Hirschfield JA, Krilov LR, Dubovsky F, Yi T, Belshe RB. Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children. Pediatr Infect Dis J 2012, 31:745-751. 10.1097/INF.0b013e31825687b0, 22466322.
32. Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine 2011, 29:9391-9397. 10.1016/j.vaccine.2011.09.109, 21983154.
33. Belongia EA, Kieke BA, Donahue JG, Coleman LA, Irving SA, Meece JK, Vandermause M, Lindstrom S, Gargiullo P, Shay DK. Influenza vaccine effectiveness in Wisconsin during the 2007-08 season: comparison of interim and final results. Vaccine 2011, 29:6558-6563. 10.1016/j.vaccine.2011.07.002, 21767593.
34. Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical Efficacy of Cell Culture-Derived and Egg-Derived Inactivated Subunit Influenza Vaccines in Healthy Adults. Clin Infect Dis 2010, 51:997-1004. 10.1086/656578, 20868284.
35. Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative Efficacy of Inactivated and Live Attenuated Influenza Vaccines. N Engl J Med 2009, 361:1260-1267. 10.1056/NEJMoa0808652, 19776407.
36. Reed C, Meltzer MI, Finelli L, Fiore A. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine 2012, 30:1993-1998. 10.1016/j.vaccine.2011.12.098, 22226861.
37. Lee BY, Bartsch SM, Willig AM. The economic value of a quadrivalent versus trivalent influenza vaccine. Vaccine 2012, 30:7443-7446. 10.1016/j.vaccine.2012.10.025, 23084849.
38. 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 AS03A-adjuvant: preliminary report of an observer-blind, randomised trial. Vaccine 2010, 28:1740-1745. 10.1016/j.vaccine.2009.12.014, 20034605.
39. Curran MP, Leroux-Roels I. Inactivated split-virion seasonal influenza vaccine (Fluarix): a review of its use in the prevention of seasonal influenza in adults and the elderly. Drugs 2010, 70:1519-1543. 10.2165/11205020-000000000-00000, 20687619.
40. Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nøstbakken JK, Nilsen M, Mohn K, Jul-Larsen A, Smith I, Major D, Wood J, Cox RJ. An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers. Vaccine 2010, 29:266-273. 10.1016/j.vaccine.2010.10.038, 21034828.
41. Roman F, Vaman T, Kafeja F, Hanon E, Van Damme P. AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin Infect Dis 2010, 51:668-677. 10.1086/655830, 20687838.
42. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009, 361:2424-2435. 10.1056/NEJMoa0907650, 19745215.
43. Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, Li RC, Xia SL, Zhao YL, Li FJ, Yan SH, Yin WD, An K, Feng DJ, Cui XL, Qi FC, Ju CJ, Zhang YH, Guo ZJ, Chen PY, Chen Z, Yan KM, Wang Y. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010, 375:56-66. 10.1016/S0140-6736(09)62003-1, 20018364.
44. Wu J, Li W, Wang HQ, Chen JT, Lv M, Zhou JC, Liang XF, Fang HH, Liu Y, Liu LY, Wang X, Zhang WL, Zhang XM, Song LF, Qiu YZ, Li CG, Wang JZ, Wang Y, Yin WD. A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis 2010, 202:675-680. 10.1086/655226, 20632888.
45. Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis 2010, 201:1644-1653. 10.1086/652701, 20423222.
46. Monto AS, Hornbuckle K, Ohmit SE. Influenza vaccine effectiveness among elderly nursing home residents: a cohort study. Am J Epidemiol 2001, 154:155-160. 10.1093/aje/154.2.155, 11447049.