Statistical Analysis of Influenza Vaccine Lot Consistency Studies

REFERENCES

• Armitage , P. , Berry , G. ( 1994 ). Statistical Methods in Medical Research. , 3rd ed. Blackwell Science , pp. 128 – 130 .
   Google Scholar
• Berger , R. L. ( 1982 ). Multiparameter hypothesis testing and acceptance sampling . Technometrics 24 : 295 – 300 [CSA]
   Web of Science ®Google Scholar
• Berger , R. L. , Hsu , J. C. ( 1996 ). Bioequivalence trials, intersection-union tests and equivalence confidence sets . Statistical Sciences 11 : 283 – 319 [CROSSREF] [CSA]
   Web of Science ®Google Scholar
• Beyer , W. E. P. , Palache , A. M. , Lüchters , G. , Nauta , J. , Osterhaus , A. D. M. E. ( 2004 ). Seroprotection rate, mean fold increase, seroconversion rate: which parameter adequately expresses seroresponse to influenza vaccination? Virus Res . 103 : 125 – 132 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMed Web of Science ®Google Scholar
• De Jong , J. C. , Palache , A. M. , Beyer , W. E. P. , Rimmelzman , G. F. , Boon , A. C. M. , Osterhaus , A. D. M. E. ( 2003 ). Haemagglutination-inhibiting antibody to influenza virus . Dev. Biol. 115 : 63 – 73 [CSA]
   Google Scholar
• Dowdle , W. E. , Kendal , A. , Noble , W. R. ( 1979 ). Influenza Viruses . In: Lennette , E. H. , Schmidt , N. J. , eds. Diagnostic Procedures for Viral, Rickettsial and Chlamydial Infections. , 5th ed. Washington DC : American Public Health Association .
   Google Scholar
• Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing, and Clinical Studies . ( 1997 ). U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research [CSA]
   Google Scholar
• Lachenbruch , P. A. , Rida , W. , Kou , J. ( 2004 ). Lot consistency as an equivalence problem . J. Biopharm. Stat. 14 : 275 – 290 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMedGoogle Scholar
• Nolan , T. , Lee , M. S. , Cordova , J. M. , Cho , I. , Walker , R. E. , August , M. J. , Larson , S. , Coelingh , K. L. , Mendelman , P. M. ( 2003 ). Safety and immunogenicity of a live-attenuated influenza vaccine blended and filled at two manufacturing facilities . Vaccine 21 : 1224 – 1231 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMed Web of Science ®Google Scholar
• Note for Guidance on Harmonisation of Requirements for Influenza Vaccines . ( 1997 ). Committee for Proprietary Medicinal Products (CPMP). CPMP/BWP/214/96.[CSA]
   Google Scholar
• Note for Guidance on Clinical Evaluation of New Vaccines. Committee for Proprietary Medicinal Products (CPMP) . ( 1999 ). CPMP/EWP/463/97.[INFOTRIEVE] [CSA]
   Google Scholar
• Schuirmann , D. ( 1987 ). A comparison of the two one-sided tests procedure and the power for assessing the equivalence of average bioavailability . J. Pharmacokinet. Biopharm. 15 : 657 – 80 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMedGoogle Scholar
• Statistical Principles for Clinical Trials . ( 1998 ). International Conference on Harmonization (ICH) E9 Expert Working Group.[CSA]
   Google Scholar
• Wiens , B. L. , Iglewicz , B. ( 1999 ). On testing equivalence of three populations . J. Biopharm. Stat. 9 : 465 – 483 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMedGoogle Scholar
• Wiens , B. L. , Iglewicz , B. ( 2000 ). Design and analysis of three treatment equivalence trials . Control. Clin. Trials 21 : 127 – 137 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMedGoogle Scholar
• Wiens , B. L. ( 2002 ). Choosing an equivalence limit for noninferiority or equivalence studies . Control. Clin. Trials 23 : 2 – 14 [INFOTRIEVE] [CROSSREF] [CSA]
   PubMedGoogle Scholar
• Zangwill , K. M. , Droge , J. , Mendelman , P. , Marcy , M. , Partridge , S. , Chiu , C. Y. , Jing , J. , Chang , S. J. , Cho , I. , Ward , J. I. ( 2001 ). Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children . J. Pediatr. Infect. Dis. 20 : 740 – 746 [CROSSREF] [CSA]
   PubMedGoogle Scholar