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Volumn 19, Issue 2-3, 2000, Pages 319-326

Intent-to-treat analysis and preventive vaccine efficacy

Author keywords

Clinical trials; Intent to treat; Per protocol

Indexed keywords

VACCINE;

EID: 0034666744     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(00)00152-3     Document Type: Article
Times cited : (22)

References (45)
  • 1
    • 0003349279 scopus 로고
    • Exclusions, losses to follow-up, and withdrawals in clinical trials
    • S. Shapiro, & T.A. Louis. New York: Dekker
    • Armitage P. Exclusions, losses to follow-up, and withdrawals in clinical trials. Shapiro S., Louis T.A. Clinical trials: issues and approaches. 1983;Dekker, New York.
    • (1983) Clinical Trials: Issues and Approaches
    • Armitage, P.1
  • 2
    • 1842540786 scopus 로고
    • Monitoring clinical trial data for evidence of adverse or beneficial treatment effects
    • Canner P.L. Monitoring clinical trial data for evidence of adverse or beneficial treatment effects. INSERM. 76:1977;131-149.
    • (1977) INSERM , vol.76 , pp. 131-149
    • Canner, P.L.1
  • 5
    • 0021818101 scopus 로고
    • Eligibility exclusions, losses to follow-up, removal of randomized patients, and uncounted events in cancer clinical trials
    • Gail M.H. Eligibility exclusions, losses to follow-up, removal of randomized patients, and uncounted events in cancer clinical trials. Cancer Treat. Rep. 69:1985;1107-1113.
    • (1985) Cancer Treat. Rep. , vol.69 , pp. 1107-1113
    • Gail, M.H.1
  • 6
    • 0018803093 scopus 로고
    • The qualification and disqualification of patients and events in long-term cardiovascular clinical trials
    • Gent M., Sackett D.L. The qualification and disqualification of patients and events in long-term cardiovascular clinical trials. Thrombos. Haemostas. 41:1979;123-134.
    • (1979) Thrombos. Haemostas. , vol.41 , pp. 123-134
    • Gent, M.1    Sackett, D.L.2
  • 7
    • 0025949416 scopus 로고
    • The application of the principle of intention-to-treat to the analysis of clinical trials
    • Gillings D., Koch G.G. The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Inform. J. 25:1991;411-424.
    • (1991) Drug Inform. J. , vol.25 , pp. 411-424
    • Gillings, D.1    Koch, G.G.2
  • 8
    • 0025862037 scopus 로고
    • Analysis of clinical trials by treatment actually received: Is it really an option?
    • Lee Y.J., Ellenberg J.H., Hirtz D.G., Nelson K.B. Analysis of clinical trials by treatment actually received: is it really an option? Stat. Med. 10:1991;1595-1605.
    • (1991) Stat. Med. , vol.10 , pp. 1595-1605
    • Lee, Y.J.1    Ellenberg, J.H.2    Hirtz, D.G.3    Nelson, K.B.4
  • 9
    • 0027432633 scopus 로고
    • Intention to treat - who should use ITT?
    • Lewis J.A., Machin D. Intention to treat - who should use ITT? Br. J. Cancer. 68:1993;647-650.
    • (1993) Br. J. Cancer , vol.68 , pp. 647-650
    • Lewis, J.A.1    MacHin, D.2
  • 11
    • 0008544846 scopus 로고
    • Statistical analysis of clinical trials
    • S.H. Shapiro, & T.A. Louis. New York: Dekker
    • Meier P. Statistical analysis of clinical trials. Shapiro S.H., Louis T.A. Clinical trials. 1983;Dekker, New York.
    • (1983) Clinical Trials
    • Meier, P.1
  • 13
    • 0017042882 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
    • Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br. J. Cancer. 34:1976;585-612.
    • (1976) Br. J. Cancer , vol.34 , pp. 585-612
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 14
    • 0017365573 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples
    • Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br. J. Cancer. 35:1977;1-39.
    • (1977) Br. J. Cancer , vol.35 , pp. 1-39
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 16
    • 0018640322 scopus 로고
    • Controversy in counting and attributing events in clinical trials
    • Sackett D.L., Gent M. Controversy in counting and attributing events in clinical trials. New Engl. J. Med. 301:1979;1410-1412.
    • (1979) New Engl. J. Med. , vol.301 , pp. 1410-1412
    • Sackett, D.L.1    Gent, M.2
  • 17
    • 0343631124 scopus 로고    scopus 로고
    • Long-term evaluation of vaccine protection: Methodological issues for phase 3 trials and phase 4 studies
    • M.M. Levine, G.C. Woodrow, J.B. Kaper, & G.S. Cobon. New York: Dekker
    • Clemens J.D., Naficy A., Rao M.R. Long-term evaluation of vaccine protection: methodological issues for phase 3 trials and phase 4 studies. Levine M.M., Woodrow G.C., Kaper J.B., Cobon G.S. New generation vaccines. 2nd ed. 1997;Dekker, New York.
    • (1997) New Generation Vaccines 2nd Ed.
    • Clemens, J.D.1    Naficy, A.2    Rao, M.R.3
  • 18
    • 0031445753 scopus 로고    scopus 로고
    • A review of the design of vaccine efficacy trials and a proposal for the design of the VA cooperative study of active immunotherapy of HIV infection
    • Peduzzi P., Donta S., Iwane M. A review of the design of vaccine efficacy trials and a proposal for the design of the VA cooperative study of active immunotherapy of HIV infection. Controlled Clin. Trials. 18:1997;397-419.
    • (1997) Controlled Clin. Trials , vol.18 , pp. 397-419
    • Peduzzi, P.1    Donta, S.2    Iwane, M.3
  • 19
    • 0032502697 scopus 로고    scopus 로고
    • Active immunization of patients with HIV infection: A study of the effect of VaxSyn, a recombinant HIV envelope subunit vaccine, on progression of immunodeficiency
    • Tsoukas C.M., Raboud J., Bernard N.F., et al. Active immunization of patients with HIV infection: a study of the effect of VaxSyn, a recombinant HIV envelope subunit vaccine, on progression of immunodeficiency. AIDS Res. Hum. Retroviruses. 14:1998;483-490.
    • (1998) AIDS Res. Hum. Retroviruses , vol.14 , pp. 483-490
    • Tsoukas, C.M.1    Raboud, J.2    Bernard, N.F.3
  • 20
    • 10544220020 scopus 로고    scopus 로고
    • Randomised trial of MNrgp120 HIV-1 vaccine in symptomless HIV-1 infection
    • Eron J.J. Jr, Ashby M.A., Giordano M.F., et al. Randomised trial of MNrgp120 HIV-1 vaccine in symptomless HIV-1 infection. Lancet. 348:1996;1547-1551.
    • (1996) Lancet , vol.348 , pp. 1547-1551
    • Eron J.J., Jr.1    Ashby, M.A.2    Giordano, M.F.3
  • 21
    • 16944362192 scopus 로고    scopus 로고
    • Immunotherapy of recurrent genital herpes with recombinant herpes simplex virus type 2 glycoproteins D and B: Results of a placebo-controlled vaccine trial
    • Straus S.E., Wald A., Kost R.G., et al. Immunotherapy of recurrent genital herpes with recombinant herpes simplex virus type 2 glycoproteins D and B: results of a placebo-controlled vaccine trial. J. Infect. Dis. 176:1997;1129-1134.
    • (1997) J. Infect. Dis. , vol.176 , pp. 1129-1134
    • Straus, S.E.1    Wald, A.2    Kost, R.G.3
  • 22
    • 0028284460 scopus 로고
    • Placebo-controlled trial of vaccination with recombinant glycoprotein D of herpes simplex virus type 2 for immunotherapy of genital herpes
    • Straus S.E., Corey L., Burke R.L., et al. Placebo-controlled trial of vaccination with recombinant glycoprotein D of herpes simplex virus type 2 for immunotherapy of genital herpes. Lancet. 343:1994;1460-1463.
    • (1994) Lancet , vol.343 , pp. 1460-1463
    • Straus, S.E.1    Corey, L.2    Burke, R.L.3
  • 23
    • 0032561943 scopus 로고    scopus 로고
    • Understanding controlled trials: What are pragmatic trials?
    • Roland M., Torgerson D.J. Understanding controlled trials: what are pragmatic trials? B.M.J. 316:1998;285.
    • (1998) B.M.J. , vol.316 , pp. 285
    • Roland, M.1    Torgerson, D.J.2
  • 24
    • 0031781265 scopus 로고    scopus 로고
    • Drug compliance in therapeutic trials: A review
    • Boudes P. Drug compliance in therapeutic trials: a review. Controlled Clin. Trials. 19:1998;257-268.
    • (1998) Controlled Clin. Trials , vol.19 , pp. 257-268
    • Boudes, P.1
  • 25
    • 13344286322 scopus 로고    scopus 로고
    • A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis
    • Greco D., Salmaso S., Mastrantonio P., et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N. Engl. J. Med. 334:1996;341-348.
    • (1996) N. Engl. J. Med. , vol.334 , pp. 341-348
    • Greco, D.1    Salmaso, S.2    Mastrantonio, P.3
  • 26
    • 0030058665 scopus 로고    scopus 로고
    • A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine
    • Gustafsson L., Hallander H.O., Olin P., Reizenstein E., Storsaeter J. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N. Engl. J. Med. 334:1996;349-355.
    • (1996) N. Engl. J. Med. , vol.334 , pp. 349-355
    • Gustafsson, L.1    Hallander, H.O.2    Olin, P.3    Reizenstein, E.4    Storsaeter, J.5
  • 28
    • 0028844977 scopus 로고
    • A placebo-controlled trial of a pertussis-toxoid vaccine
    • Trollfors B., Taranger J., Lagergard T., et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N. Engl. J. Med. 333:1995;1045-1050.
    • (1995) N. Engl. J. Med. , vol.333 , pp. 1045-1050
    • Trollfors, B.1    Taranger, J.2    Lagergard, T.3
  • 29
    • 0026428599 scopus 로고
    • The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex
    • Santosham M., Wolff M., Reid R., et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex. N. Engl. J. Med. 324:1991;1767-1772.
    • (1991) N. Engl. J. Med. , vol.324 , pp. 1767-1772
    • Santosham, M.1    Wolff, M.2    Reid, R.3
  • 30
    • 0026643021 scopus 로고
    • A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children
    • Werzberger A., Mensch B., Kuter B., et al. A controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children. N. Engl. J. Med. 327:1992;453-457.
    • (1992) N. Engl. J. Med. , vol.327 , pp. 453-457
    • Werzberger, A.1    Mensch, B.2    Kuter, B.3
  • 31
    • 0019949818 scopus 로고
    • The prevention of hepatitis B with vaccine. Report of the Centers for Disease Control multi-center efficacy trial among homosexual men
    • Francis D.P., Hadler S.C., Thompson S.E., et al. The prevention of hepatitis B with vaccine. Report of the Centers for Disease Control multi-center efficacy trial among homosexual men. Ann. Intern. Med. 97:1982;362-366.
    • (1982) Ann. Intern. Med. , vol.97 , pp. 362-366
    • Francis, D.P.1    Hadler, S.C.2    Thompson, S.E.3
  • 33
    • 0032560841 scopus 로고    scopus 로고
    • Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group
    • Steere A.C., Sikand V.K., Meurice F., et al. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group. N. Engl. J. Med. 339:1998;209-215.
    • (1998) N. Engl. J. Med. , vol.339 , pp. 209-215
    • Steere, A.C.1    Sikand, V.K.2    Meurice, F.3
  • 37
    • 0032851817 scopus 로고    scopus 로고
    • Francis field trial of inactivated poliomyelitis vaccine: Background and lessons for today
    • Monto A.S. Francis field trial of inactivated poliomyelitis vaccine: background and lessons for today. Epidemiol. Rev. 21:1999;7-23.
    • (1999) Epidemiol. Rev. , vol.21 , pp. 7-23
    • Monto, A.S.1
  • 38
    • 0023633872 scopus 로고
    • Protective activity of Vi capsular polysaccharide vaccine against typhoid fever
    • Klugman K.P., Gilbertson I.T., Koornhof H.J., et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. Lancet. 2:1987;1165-1169.
    • (1987) Lancet , vol.2 , pp. 1165-1169
    • Klugman, K.P.1    Gilbertson, I.T.2    Koornhof, H.J.3
  • 39
  • 40
    • 0026033321 scopus 로고
    • Efficacy in infancy of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in a United States population of 61,080 children
    • Black S.B., Shinefield H.R., Fireman B., Hiatt R., Polen M., Vittinghoff E. Efficacy in infancy of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in a United States population of 61,080 children. Pediatr. Infect. Dis. J. 10:1991;97-104.
    • (1991) Pediatr. Infect. Dis. J. , vol.10 , pp. 97-104
    • Black, S.B.1    Shinefield, H.R.2    Fireman, B.3    Hiatt, R.4    Polen, M.5    Vittinghoff, E.6
  • 41
    • 4243836125 scopus 로고
    • Haemophilus influenzae type b vaccines
    • K.R. Stratton, C.J. Howe, & R.B. Jr. Johnston. Washington, DC: National Academy Press
    • Vaccine Safety Committee. Haemophilus influenzae type b vaccines. Stratton K.R., Howe C.J., Johnston R.B. Jr. Adverse events associated with childhood vaccines: evidence bearing on causality. 1994;National Academy Press, Washington, DC.
    • (1994) Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
    • Vaccine, S.C.1
  • 42
    • 0031005036 scopus 로고    scopus 로고
    • Adjusting for non-compliance and contamination in randomized clinical trials
    • Cuzick J., Edwards R., Segnan N. Adjusting for non-compliance and contamination in randomized clinical trials. Stat. Med. 16:1997;1017-1029.
    • (1997) Stat. Med. , vol.16 , pp. 1017-1029
    • Cuzick, J.1    Edwards, R.2    Segnan, N.3
  • 43
    • 0000936017 scopus 로고    scopus 로고
    • International Conference on Harmonisation. Statistical Principles for Clinical Trials. Efficacy Guidelines
    • International Conference on Harmonisation. Statistical Principles for Clinical Trials. Efficacy Guidelines. Federal Reg 1998;63:49,583-49,598 ( www.fda.gov/cber/guidelines.htm ).
    • (1998) Federal Reg , vol.63 , pp. 49583-49598
  • 44
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones B., Jarvis P., Lewis J.A., Ebbutt A.F. Trials to assess equivalence: the importance of rigorous methods. BMJ. 313:1996;36-39.
    • (1996) BMJ , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 45
    • 0032238125 scopus 로고    scopus 로고
    • Measuring protection: Efficacy versus effectiveness
    • Fedson D.S. Measuring protection: efficacy versus effectiveness. Dev. Biol. Stand. 95:1998;195-201.
    • (1998) Dev. Biol. Stand. , vol.95 , pp. 195-201
    • Fedson, D.S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.