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Volumn 25, Issue 33, 2007, Pages 6237-6244

Assessing vaccine efficacy for the prevention of acute otitis media by pneumococcal vaccination in children: A methodological overview of statistical practice in randomized controlled clinical trials

Author keywords

Pneumococcal vaccination; Statistical analysis; Vaccine efficacy

Indexed keywords

ANTIBIOTIC AGENT; HEPATITIS A VACCINE; PLACEBO; PNEUMOCOCCUS VACCINE;

EID: 34447650427     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2007.05.062     Document Type: Article
Times cited : (13)

References (36)
  • 2
    • 0036634754 scopus 로고    scopus 로고
    • Treatment of acute otitis media consensus recommendations
    • Hoberman A., Marchant C.D., Kaplan S.L., and Feldman S. Treatment of acute otitis media consensus recommendations. Clin Pediatr 41 6 (2002) 373-390
    • (2002) Clin Pediatr , vol.41 , Issue.6 , pp. 373-390
    • Hoberman, A.1    Marchant, C.D.2    Kaplan, S.L.3    Feldman, S.4
  • 3
    • 33645299048 scopus 로고    scopus 로고
    • Bacterial etiology of acute otitis media and clinical efficacy of amoxicillin-clavulanate versus azithromycin
    • Guven M., Bulut Y., Sezer T., Aladag I., Eyibilen A., and Etikan I. Bacterial etiology of acute otitis media and clinical efficacy of amoxicillin-clavulanate versus azithromycin. Int J Pediatr Otorhinolaryngol 70 (2006) 915-923
    • (2006) Int J Pediatr Otorhinolaryngol , vol.70 , pp. 915-923
    • Guven, M.1    Bulut, Y.2    Sezer, T.3    Aladag, I.4    Eyibilen, A.5    Etikan, I.6
  • 6
    • 2942748258 scopus 로고    scopus 로고
    • Straetemans M, Sanders EAM, Veenhoven RH, Schilder AGM, Damoiseaux RAMJ, Zielhuis GA. Pneumococcal vaccines for preventing otitis media (review). The Cochrane Collaboration, http://www.thecochranelibrary.com; 2006 [accessed July 21, 2006].
  • 7
    • 0019536630 scopus 로고
    • A study of the pneumococcal vaccine in prevention of clinically acute atttacks of recurrent otitis media
    • Makela P.H., Leinonen M., Pukander J., and Karma P. A study of the pneumococcal vaccine in prevention of clinically acute atttacks of recurrent otitis media. Rev Infect Dis 3 Suppl. (1981) S124-S132
    • (1981) Rev Infect Dis , vol.3 , Issue.SUPPL
    • Makela, P.H.1    Leinonen, M.2    Pukander, J.3    Karma, P.4
  • 8
    • 0019536676 scopus 로고
    • Efficacy of pneumococcal polysaccharide vaccine in preventing acute otitis media in infants in Huntsville, Alabama
    • Sloyer Jr. J.L., Ploussard J.H., and Howie V.M. Efficacy of pneumococcal polysaccharide vaccine in preventing acute otitis media in infants in Huntsville, Alabama. Rev Infect Dis 3 Suppl. (1981) S119-S123
    • (1981) Rev Infect Dis , vol.3 , Issue.SUPPL
    • Sloyer Jr., J.L.1    Ploussard, J.H.2    Howie, V.M.3
  • 9
    • 0019537182 scopus 로고
    • Use of pneumococcal vaccine for prevention of recurrent acute otitis media in infants in Boston
    • Teele D.W., Klein J.O., Bratton L., Fisch G.R., Mathieu O.R., Porter P.J., et al. Use of pneumococcal vaccine for prevention of recurrent acute otitis media in infants in Boston. Rev Infect Dis 3 (1981) S113-S118
    • (1981) Rev Infect Dis , vol.3
    • Teele, D.W.1    Klein, J.O.2    Bratton, L.3    Fisch, G.R.4    Mathieu, O.R.5    Porter, P.J.6
  • 10
    • 0020794678 scopus 로고
    • Prophylaxis of otitis media in asthmatic children
    • Schuller D.E. Prophylaxis of otitis media in asthmatic children. Pediatr Infect Dis 2 4 (1983) 280-283
    • (1983) Pediatr Infect Dis , vol.2 , Issue.4 , pp. 280-283
    • Schuller, D.E.1
  • 11
    • 0021279799 scopus 로고
    • Vaccination against Streptococcus pneumoniae in childhood: lack of demonstrable benefit in young Australian children
    • Douglas R.M. Vaccination against Streptococcus pneumoniae in childhood: lack of demonstrable benefit in young Australian children. J Infect Dis 149 6 (1984) 861-869
    • (1984) J Infect Dis , vol.149 , Issue.6 , pp. 861-869
    • Douglas, R.M.1
  • 14
    • 0023025739 scopus 로고
    • Pneumococcal vaccine in aboriginal children-a randomized controlled trial involving 60 children
    • Douglas R.M., Hansman D., McDonald B., Paton J., and Kirke K. Pneumococcal vaccine in aboriginal children-a randomized controlled trial involving 60 children. Community Health Stud 10 2 (1986) 189-196
    • (1986) Community Health Stud , vol.10 , Issue.2 , pp. 189-196
    • Douglas, R.M.1    Hansman, D.2    McDonald, B.3    Paton, J.4    Kirke, K.5
  • 15
    • 0034063425 scopus 로고    scopus 로고
    • Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group
    • Black S., Shinefield H., Fireman B., Lewis E., Ray P., Hansen J.R., et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J 19 3 (2000) 187-195
    • (2000) Pediatr Infect Dis J , vol.19 , Issue.3 , pp. 187-195
    • Black, S.1    Shinefield, H.2    Fireman, B.3    Lewis, E.4    Ray, P.5    Hansen, J.R.6
  • 16
    • 0035825720 scopus 로고    scopus 로고
    • Efficacy of a pneumococcal conjugate vaccine against acute otitis media
    • Eskola J., et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 344 6 (2001) 403-409
    • (2001) N Engl J Med , vol.344 , Issue.6 , pp. 403-409
    • Eskola, J.1
  • 17
    • 0034795884 scopus 로고    scopus 로고
    • Effect of a conjugate pneumococcal vaccine on the occurrence of respiratory infections and antibiotic use in day-care center attendees
    • Dagan R., Sikuler-Cohen M., Zamir O., Janco J., Givon-Lavi N., and Fraser D. Effect of a conjugate pneumococcal vaccine on the occurrence of respiratory infections and antibiotic use in day-care center attendees. Pediatr Infect Dis J 20 10 (2001) 951-958
    • (2001) Pediatr Infect Dis J , vol.20 , Issue.10 , pp. 951-958
    • Dagan, R.1    Sikuler-Cohen, M.2    Zamir, O.3    Janco, J.4    Givon-Lavi, N.5    Fraser, D.6
  • 18
    • 0012642994 scopus 로고    scopus 로고
    • Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study
    • Veenhoven R., Bogaert D., Uiterwaal C., Brouwer C., Kiezebrink H., Bruin J., et al. Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study. Lancet 361 9376 (2003) 2189-2195
    • (2003) Lancet , vol.361 , Issue.9376 , pp. 2189-2195
    • Veenhoven, R.1    Bogaert, D.2    Uiterwaal, C.3    Brouwer, C.4    Kiezebrink, H.5    Bruin, J.6
  • 19
    • 33644645379 scopus 로고    scopus 로고
    • Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study
    • Prymula R., Peeters P., Chrobok V., Kriz P., Novakova E., Kaliskova E., et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 367 9512 (2006) 740-748
    • (2006) Lancet , vol.367 , Issue.9512 , pp. 740-748
    • Prymula, R.1    Peeters, P.2    Chrobok, V.3    Kriz, P.4    Novakova, E.5    Kaliskova, E.6
  • 21
    • 0033618531 scopus 로고    scopus 로고
    • Estimation of the treatment effect in a clinical trial when recurrent events define the endpoint
    • Mahe C., and Chevret S. Estimation of the treatment effect in a clinical trial when recurrent events define the endpoint. Stat Med 18 (1999) 1821-1829
    • (1999) Stat Med , vol.18 , pp. 1821-1829
    • Mahe, C.1    Chevret, S.2
  • 23
    • 33645961318 scopus 로고    scopus 로고
    • Systematic literature review of modifiable risk factors for recurrent acute otitis media in childhood
    • Neto J.F.L., Hemb L., and e Silva D.B. Systematic literature review of modifiable risk factors for recurrent acute otitis media in childhood. J Pediatr (Rio J) 82 2 (2006) 87-96
    • (2006) J Pediatr (Rio J) , vol.82 , Issue.2 , pp. 87-96
    • Neto, J.F.L.1    Hemb, L.2    e Silva, D.B.3
  • 24
    • 84950455841 scopus 로고
    • Tests of hypotheses in overdispersed Poisson regression and other quasi-likelihood models
    • Breslow N. Tests of hypotheses in overdispersed Poisson regression and other quasi-likelihood models. J Am Stat Assoc 85 410 (1990) 565-571
    • (1990) J Am Stat Assoc , vol.85 , Issue.410 , pp. 565-571
    • Breslow, N.1
  • 25
    • 34447646788 scopus 로고    scopus 로고
    • Methods for analysing recurrent events in health care data. Examples from admissions in Ebeltoft Health Promotion Project
    • Thomsen J.L., and Parner E.T. Methods for analysing recurrent events in health care data. Examples from admissions in Ebeltoft Health Promotion Project. Fam Pract 23 4 (2006) 407-413
    • (2006) Fam Pract , vol.23 , Issue.4 , pp. 407-413
    • Thomsen, J.L.1    Parner, E.T.2
  • 26
    • 0001646484 scopus 로고
    • Cox regression model for counting processes: a large sample study
    • Andersen P.K., and Gill R.D. Cox regression model for counting processes: a large sample study. Ann Stat 10 (1982) 1100-1120
    • (1982) Ann Stat , vol.10 , pp. 1100-1120
    • Andersen, P.K.1    Gill, R.D.2
  • 27
    • 0034650320 scopus 로고    scopus 로고
    • Survival analysis for recurrent event data: an application to childhood infectious diseases
    • Kelly P.J., and Lim L.L. Survival analysis for recurrent event data: an application to childhood infectious diseases. Stat Med 19 1 (2000) 13-33
    • (2000) Stat Med , vol.19 , Issue.1 , pp. 13-33
    • Kelly, P.J.1    Lim, L.L.2
  • 28
    • 31344451379 scopus 로고    scopus 로고
    • The importance of varying the event generation process in simulation studies of statistical methods for recurrent events
    • Metcalfe C., and Thompson S.G. The importance of varying the event generation process in simulation studies of statistical methods for recurrent events. Stat Med 25 1 (2006) 165-179
    • (2006) Stat Med , vol.25 , Issue.1 , pp. 165-179
    • Metcalfe, C.1    Thompson, S.G.2
  • 29
    • 84892372742 scopus 로고
    • The robust inference for the Cox proportional hazards model
    • Lin D.Y., and Wei L.J. The robust inference for the Cox proportional hazards model. J Am Stat Assoc 84 (1989) 1074-1078
    • (1989) J Am Stat Assoc , vol.84 , pp. 1074-1078
    • Lin, D.Y.1    Wei, L.J.2
  • 31
    • 0242574974 scopus 로고    scopus 로고
    • Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children
    • Kilpi T., et al. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis 37 9 (2003) 1155-1164
    • (2003) Clin Infect Dis , vol.37 , Issue.9 , pp. 1155-1164
    • Kilpi, T.1
  • 33
    • 70349813434 scopus 로고
    • On the regression analysis of multivariate failure time data
    • Prentice R.L., Williams B.J., and Peterson A.V. On the regression analysis of multivariate failure time data. Biometrika 68 (1981) 373-389
    • (1981) Biometrika , vol.68 , pp. 373-389
    • Prentice, R.L.1    Williams, B.J.2    Peterson, A.V.3
  • 34
    • 79953752268 scopus 로고
    • Regression analysis of multivariate incomplete failure time data by modeling marginal distributions
    • Wei L.J., Lin D.Y., and Weissfeld L. Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc 84 (1989) 1065-1073
    • (1989) J Am Stat Assoc , vol.84 , pp. 1065-1073
    • Wei, L.J.1    Lin, D.Y.2    Weissfeld, L.3
  • 35
    • 0028954425 scopus 로고
    • Events per person year-a dubious concept
    • Windeler J., and Lange S. Events per person year-a dubious concept. BMJ 310 6977 (1995) 454-456
    • (1995) BMJ , vol.310 , Issue.6977 , pp. 454-456
    • Windeler, J.1    Lange, S.2
  • 36
    • 0026033844 scopus 로고
    • Direct and indirect effects in vaccine efficacy and effectiveness
    • Halloran M.E., Haber M., Longini Jr. I.M., and Struchiner C.J. Direct and indirect effects in vaccine efficacy and effectiveness. Am J Epidemiol 133 4 (1991) 323-331
    • (1991) Am J Epidemiol , vol.133 , Issue.4 , pp. 323-331
    • Halloran, M.E.1    Haber, M.2    Longini Jr., I.M.3    Struchiner, C.J.4


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