Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: A randomized study in US adults

Human Vaccines

Volumn 7, Issue 1, 2011, Pages 81-88

  Campbell, James D ^a   Chambers, Christopher V ^b   Brady, Rebecca C ^c   Caldwell, Michael C ^d   Bennett, Nathan L ^e   Fourneau, Marc A ^f   Jain, Varsha K ^g   Innis, Bruce L ^g  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d Dutchess County Department of Health   (United States)

^e Preferred Primary Care Physicians   (United States)

^f GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^g GLAXOSMITHKLINE   (United States)

Author keywords

Adults; Influenza; Non inferiority; Trivalent inactivated; Vaccine

Indexed keywords

INFLUENZA VACCINE;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; COUGHING; DRUG APPROVAL; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HEMAGGLUTINATION; HUMAN; IMMUNOGENICITY; INFLUENZA; INFLUENZA A (H1N1); INFLUENZA A (H3N2); INFLUENZA B; INFLUENZA VACCINATION; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MYALGIA; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEROCONVERSION; SHIVERING; SINGLE BLIND PROCEDURE; SORE THROAT; UNITED STATES; VIRUS STRAIN;

EID: 79551701150     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.7.1.13553     Document Type: Article

References (32)

1. World Health Organization. WHO [http://www.who.int/mediacentre/ factsheets/fs211/en]. Fact sheet no 211 2003.
2. Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003; 289:179-86. (Pubitemid 36068705)
3. Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, et al. Influenza-associated hospitalizations in the United States. JAMA 2004; 292:1333-40. (Pubitemid 39223224)
4. Mullooly JP, Bridges CB, Thompson WW, Chen J, Weintraub E, Jackson LA, et al. Influenza- and RSV-associated hospitalizations among adults. Vaccine 2007; 25:846-55. (Pubitemid 44873160)
5. O'Brien MA, Uyeki TM, Shay DK, Thompson WW, Kleinman K, McAdam A, et al. Incidence of outpatient visits and hospitalizations related to influenza in infants and young children. Pediatrics 2004; 113:585-93. (Pubitemid 38280802)
6. Centers for Disease Control and Prevention: Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP) 2007. MMWR 2007; 56:1-54.
7. Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, et al. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: A randomized controlled trial. JAMA 2000; 284:1655-63.
8. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2007; 1269.
9. Beran J, Wertzova V, Honegr K, Kaliskova E, Havlickova M, Havlik J, et al. 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. Skowronski DM, Masaro C, Kwindt TL, Mak A, Petric M, Li Y, et al. Estimating vaccine effectiveness against laboratory-confirmed influenza using a sentinel physician network: results from the 2005-2006 season of dual A and B vaccine mismatch in Canada. Vaccine 2007; 25:2842-51.
11. Herrera GA, Iwane MK, Cortese M, Brown C, Gershman K, Shupe A, et al. Influenza vaccine effectiveness among 50-64 year-old persons during a season of poor antigenic match between vaccine and circulating influenza virus strains: Colorado, United States 2003-2004. Vaccine 2007; 25:154-60. (Pubitemid 44855254)
12. Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine 2006; 24:1159-69. (Pubitemid 43202262)
13. Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med 2007; 357:1373-81. (Pubitemid 47535592)
14. Vu T, Farish S, Jenkins M, Kelly H. A meta-analysis of effectiveness of influenza vaccine in persons aged 65 years and over living in the community. Vaccine 2002; 20:1831-6. (Pubitemid 34242840)
15. Nichol KL. The efficacy, effectiveness and cost-effectiveness of inactivated influenza virus vaccines. Vaccine 2003; 21:1769-75. (Pubitemid 36398371)
16. Nichol KL, Nordin J, Mullooly J. Influence of clinical outcome and outcome period definitions on estimates of absolute clinical and economic benefits of influenza vaccination in community dwelling elderly persons. Vaccine 2006; 24:1562-8. (Pubitemid 43238231)
17. Rothberg MB, Rose DN. Vaccination versus treatment of influenza in working adults: a cost-effectiveness analysis. Am J Med 2005; 118:68-77. (Pubitemid 40082461)
18. Centers for Disease Control and Prevention: Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP) 2008. MMRW 2008; 57:1-60.
19. Treanor JJ, Campbell JD, Brady RC, Keitel WA, Drame M, Jain VK, et al. Rapid licensure of a new, inactivated influenza vaccine in the United States. Hum Vaccin 2005; 1:239-44.
20. Baras B, Bouveret N, Devaster JM, Fries L, Gillard P, Sänger R, et al. A vaccine manufacturer's approach to address medical needs related to seasonal and pandemic influenza viruses. Influenza Other Respi Viruses 2008; 2:251-60.
21. El Sahly HM, Keitel WA. Clinical data on Fluarix: an inactivated split seasonal influenza vaccine. Expert Rev Vaccines 2008; 7:713-9.
22. Hehme NW, 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; 22:751-69. (Pubitemid 35388185)
23. Rose GW, Cooper CL. Fluarix, inactivated split-virus influenza vaccine. Expert Opin Biol Ther 2006; 6:301-10. (Pubitemid 43344748)
24. Weinberger B, Keller M, Fischer KH, Stiasny K, Neuner C, Heinz FX. Decreased antibody titers and booster responses in tick-borne encephalitis vaccinees aged 50-90 years. Vaccine 2010; 28:3511-5.
25. Wolters B, Junge U, Dziuba S, Roggendorf M. Immunogenicity of combined hepatitis A and B vaccine in elderly persons. Vaccine 2003; 21:3623-8. (Pubitemid 37338186)
26. Kaml M, Weiskirchner I, Keller M, Luft T, Hoster E, Hasford J, et al. Booster vaccination in the elderly: their success depends on the vaccine type applied earlier in life as well as on pre-vaccination antibody titers. Vaccine 2006; 24:6808-11. (Pubitemid 46127445)
27. Weinberger B, Herndler-Brandstetter D, Schwanninger A, Weiskopf D, Grubeck-Loebenstein B. Biology of immune responses to vaccines in elderly persons. Clin Infect Dis 2008; 46:1078-84. (Pubitemid 351589876)
28. Belongia E, Kieke B, Coleman L, Donahue J, Irving S, Meece J, et al. Interim within-season estimate of the effectiveness of trivalent inactivated influenza vaccine - Marshfield, Wisconsin 2007-08 influenza season. MMWR 2008; 57:393-7.
29. Strickler JK, Hawksworth AW, Myers C, Irvine M, Ryan MA, Russell KL. Influenza vaccine effectiveness among US military basic trainees 2005-06 season. Emerg Infect Dis 2007; 13:617-9.
30. McElhaney JE, Dutz JP. Better influenza vaccines for older people: what will it take? J Infect Dis 2008; 198:632-4.
31. Beran J, Vesikari T, Wertzova V, Karvonen A, Honegr K, Lindblad N, et al. Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective randomized placebo-controlled trial. J Infect Dis 2009; 200:1861-9.
32. Kendal AP, Pereira MS, Skehel JJ. Concepts and procedures for laboratory-based influenza surveillance. Atlanta: Centers for Disease Control and Prevention and Pan-American Health Organization 1982; 17-35.