Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: A prospective, randomized, placebo-controlled trial

Journal of Infectious Diseases

Volumn 200, Issue 12, 2009, Pages 1861-1869

  Beran, Jiri ^a,e   Vesikari, Timo ^b   Wertzova, Veronika ^a   Karvonen, Aino ^b   Honegr, Karel ^a   Lindblad, Niklas ^b   Van Belle, Pascale ^c   Peeters, Mathieu ^c   Innis, Bruce L ^d   Devaster, Jeanne Marie ^c  

^a UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^b TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^d GLAXOSMITHKLINE   (United States)

^e Vaccination and Travel Medicine Centre   (Czech Republic)

Author keywords

[No Author keywords available]

Indexed keywords

INACTIVATED VIRUS VACCINE; INFLUENZA VACCINE; PLACEBO; TRIPLE VACCINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CZECH REPUBLIC; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEVER; FINLAND; FLU LIKE SYNDROME; HUMAN; INFLUENZA; INFLUENZA VIRUS A; INFLUENZA VIRUS A H3N2; INFLUENZA VIRUS B; MALE; MULTICENTER STUDY; MYALGIA; NORMAL HUMAN; NOSE SMEAR; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SORE THROAT; THROAT CULTURE; VIRUS CULTURE; VIRUS STRAIN;

ADULT; CZECH REPUBLIC; DOUBLE-BLIND METHOD; FEMALE; FINLAND; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; PLACEBOS; PROSPECTIVE STUDIES; VACCINES, INACTIVATED; VACCINES, SUBUNIT; YOUNG ADULT;

EID: 71949128277     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/648406     Document Type: Article

References (22)

1. World Health Organization. Influenza vaccines. Wkly Epidemiol Rec 2005; 80:279-287
2. World Health Organization. Recommended composition of influenza vaccines. Available at: http://www.who.int/csr/disease/influenza/vaccinerecommendations/ en/index.html. Accessed 17 October 2008.
3. 3. Rose GW, Cooper CL. Fluarix™, inactivated split-virus influenza vaccine. Expert Opin Biol Ther 2006; 6:301-310 (Pubitemid 43344748)
4. Treanor, JJ, Campbell JD, Brady RC, et al. Rapid licensure of a new, inactivated influenza vaccine in the United States. Hum Vaccin 2005;1: 239-244
5. 5. Hehme NW, Künzel W, Petschke F, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix. Clin Drug Investig 2002; 22:751-769 (Pubitemid 35388185)
6. Beran J, Wertzova V, Honegr K, 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 Infectious Diseases 2009; 9:2.
7. Centers for Disease Control and Prevention. Overview of influenza surveillance in the United States. U.S. Influenza Sentinel Providers Surveillance Network. Available at: http://www.cdc.gov/flu/weekly/fluactivity. htm. Accessed 17 October 2008.
8. Russell CA, Jones TC, Barr IG, et al. Influenza vaccine strain selection and recent studies on the global migration of seasonal influenza viruses. Vaccine 2008; 26(Suppl 4):D31-4.
9. US Food and Drug Administration. Guidance for industry. Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. Available at: http://www.fda.gov/cber/gdlns/trifluvac.pdf. Accessed 17 October 2008.
10. European Committee for Proprietary Medicinal Products. Note for guidance on harmonization of requirements for influenza vaccines, March 1997 (CPMP/BWP/214/96). European Agency for the Evaluation of Medicinal Products, 1997.
11. 11. Jefferson T. Influenza vaccination: policy versus evidence. BMJ 2006; 333:912-915 (Pubitemid 44683514)
12. Aguillera JF, Paget WJ, Mosnieret A, et al. Heterogenous case definitions used for the surveillance of influenza in Europe. Eur J Epidemiol 2003; 18:751-754
13. Hannoun C. Case definition for influenza surveillance. Eur J Epidemiol 2003; 18:737-738
14. 14. Nichol KL, Mendelman P. Influence of clinical case definition with differing levels of sensitivity and specificity on estimates of the relative and absolute health benefits of influenza vaccination among healthy working adults and implications for economic analyses. Virus Res 2004; 103:3-8. (Pubitemid 38649052)
15. Navarro-Maŕi JM, Pérez-Ruiz M, Cantudo-Muñoz P, Petit-Gancedo C, Jiménez-Valera M, Rosa-Fraile M. Influenza-like illness criteria were poorly related to laboratory-confirmed influenza in a sentinel surveillance study. Influenza Surveillance Network in Andalusia. J Clin Epidemiol 2005; 58:275-279
16. Nichol KL. Heterogeneity of influenza case definitions and implications for interpreting and comparing study results. Vaccine 2006; 24:6726-6728
17. 17. Bell D, Nicoll A, Fukuda K, Horby P, Monto A. Nonpharmaceutical interventions for pandemic influenza, international measures. World Health Organization Writing Group. Emerg Infect Dis 2006; 12:81-87 (Pubitemid 43143541)
18. Jefferson T, Rivetti D, Di Pietrantonj C, Rivetti A, Demicheli V. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev, 2007; CDOO1269.
19. Ohmit SE, Victor JC, Rotthoff JR, et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med 2006; 355:2513-2522
20. Ohmit SE, Victor JC, Teich ER, et al. Prevention of symptomatic seasonal infuenza in 2005-2006 by inactivated and live attenuated vaccines. J Infect Dis 2008; 198:312-317
21. 21. Hoberman A, Greenberg DP, Paradise JL, et al. Effectiveness of an inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial. JAMA 2003; 290:1608-1616 (Pubitemid 37430385)
22. Call SA, Vollenweider MA, Hornung CA, Simel, DL, McKinney WP. Does this patient have influenza? JAMA 2005; 293:987-997