References
- Barr IG, McCauley J, Cox N et al.; Writing Committee of the World Health Organization Consultation on Northern Hemisphere Influenza Vaccine Composition for 2009-2010. Epidemiological, antigenic and genetic characteristics of seasonal influenza A(H1N1), A(H3N2) and B influenza viruses: basis for the WHO recommendation on the composition of influenza vaccines for use in the 2009-2010 Northern Hemisphere season. Vaccine 28(5), 1156–1167 (2010).
- Chan IS. Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies. Stat. Med. 17(12), 1403–1413 (1998).
- Nauta J. Statistics in Clinical Vaccine Trials. Springer, NY, USA (2010).
- Vesikari T, Knuf M, Wutzler P et al. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N. Engl. J. Med. 365(15), 1406–1416 (2011).
- Halloran ME, Longini IM Jr, Struchiner CJ. Design and interpretation of vaccine field studies. Epidemiol. Rev. 21(1), 73–88 (1999).
- Belshe RB, Mendelman PM, Treanor J et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N. Engl. J. Med. 338(20), 1405–1412 (1998).
- Forrest BD, Steele AD, Hiemstra L, Rappaport R, Ambrose CS, Gruber WC. A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine 29(20), 3633–3639 (2011).
- Ohmit SE, Victor JC, Rotthoff JR et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N. Engl. J. Med. 355(24), 2513–2522 (2006).
- Belshe RB, Edwards KM, Vesikari T et al.; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N. Engl. J. Med. 356(7), 685–696 (2007).
- Ohmit SE, Victor JC, Teich ER et al. Prevention of symptomatic seasonal influenza in 2005–2006 by inactivated and live attenuated vaccines. J. Infect. Dis. 198(3), 312–317 (2008).
- 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 Infect. Dis. 9, 2 (2009).
- Jackson LA, Gaglani MJ, Keyserling HL et al. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect. Dis. 10, 71 (2010).
- Beran J, Vesikari T, Wertzova V 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. 200(12), 1861–1869 (2009).
- Monto AS, Ohmit SE, Petrie JG et al. Comparative efficacy of inactivated and live attenuated influenza vaccines. N. Engl. J. Med. 361(13), 1260–1267 (2009).
- Agresti A. Categorical data analysis. Wiley, New York, USA (2002).
- Ingram DD, Kleinman JC. Empirical comparisons of proportional hazards and logistic regression models. Stat. Med. 8(5), 525–538 (1989).
- Agresti A. Exact inference for categorical data: recent advances and continuing controversies. Stat. Med. 20(17–18), 2709–2722 (2001).
- Ashkenazi S, Vertruyen A, Arístegui J et al.; CAIV-T Study Group. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr. Infect. Dis. J. 25(10), 870–879 (2006).
- Hoberman A, Greenberg D, Paradise J et al. Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children – a randomized controlled trial. J. Am. Med. Assoc. 290, 1608–1616 (2003).
- Kleinbaum DG, Klein M. Survival Analysis: A Self-Learning Text. Springer, NY, USA (2012).
- Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. Springer, NY, USA (1998).
- Senn S. Statistical Issues in Drug Development. Wiley, Chichester, UK (2007).
- Boraschi D, Del Giudice G, Dutel C, Ivanoff B, Rappuoli R, Grubeck-Loebenstein B. Ageing and immunity: addressing immune senescence to ensure healthy ageing. Vaccine 28(21), 3627–3631 (2010).
- John TJ, Samuel R. Herd immunity and herd effect: new insights and definitions. Eur. J. Epidemiol. 16(7), 601–606 (2000).
- Rappuoli R, Del Giudice G. Influenza Vaccines for the Future. Springer, NY, USA (2011).
- Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J. Infect. Dis. 204(12), 1879–1885 (2011).
- Haaheim LR, Katz JM. Immune correlates of protection against influenza: challenges for licensure of seasonal and pandemic influenza vaccines. Miami, FL, USA, March 1–3, 2010. Influenza Other Respir. Viruses 5(4), 288–295 (2011).
- Duchateau L, Janssen P. The Frailty Model. Springer, NY, USA (2008).
- Longini IM, Halloran ME. A frailty mixture model for estimating vaccine efficacy. Appl. Statist. 45, 165–173 (1996).
- Pickles A, Crouchley R. A comparison of frailty models for multivariate survival data. Stat. Med. 14(13), 1447–1461 (1995).
- Berkson J, Gage RP. Survival curves for cancer patients following treatment. J. Am. Stat. Assoc. 47, 501–515 (1952).
- McElhaney JE, Zhou X, Talbot HK et al. The unmet need in the elderly: how immunosenescence, CMV infection, co-morbidities and frailty are a challenge for the development of more effective influenza vaccines. Vaccine 30(12), 2060–2067 (2012).
- Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination. Clin. Infect. Dis. 54(11), 1615–1617 (2012).
- Monto AS, Ohmit SE. Seasonal influenza vaccines: evolutions and future trends. Expert Rev. Vaccines 8(4), 383–389 (2009).
Websites
- WHO. Influenza (Seasonal): Fact Sheet 211, April 2009. www.who.int/mediacentre/factsheets/fs211/en
- ClinicalTrials.gov. http://clinicaltrials.gov
- CDC. Morbidity and Mortality Weekly Report. www.cdc.gov/mmwr/mmwr_wk/wk_cvol.html
- FDA. Guidance for Industry, Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines, May 2007. www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091990.pdf
- WHO. Flunet. www.who.int/influenza/gisrs_laboratory/flunet/en
- EMA. Report from scientific workshop on serology assays and correlates of protection for influenza vaccines. November 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/12/WC500100205.pdf