Evaluation of vaccine seroresponse rates and adverse event rates through Bayesian and frequentist methods

References

• Nauta J. Statistics in Clinical Vaccine Trials. Berlin Heidelberg Springer-Verlag 2011:29–36.
   Google Scholar
• Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: Results from a randomized study. Hum Vaccin Immunothe 2014; 10:1155-65; http://dx.doi.org/10.4161/hv.28022
   PubMed Web of Science ®Google Scholar
• Cui F, Liang X, Wang F, Zheng H, Hutin YJ, Yang W. Development, production, and postmarketing surveillance of hepatitis A vaccines in China. J Epidemiol 2014; 24:169-77; PMID:24681843; http://dx.doi.org/10.2188/jea.JE20130022
   PubMed Web of Science ®Google Scholar
• Wang Y-J. The safety and immunogenicity of the human papillomavirus-16/18 bivalent vaccines. Xiamen, China: Xiamen University 2013.
   Google Scholar
• Low N, Redmond SM, Rutjes AW, Martinez-Gonzalez NA, Egger M, di Nisio M, Scott P. Comparing Haemophilus influenzae type b conjugate vaccine schedules: a systematic review and meta-analysis of vaccine trials. Pediatr Infect Dis J 2013; 32:1245-56; PMID:24145955; http://dx.doi.org/10.1097/INF.0b013e31829f0a7e
   PubMed Web of Science ®Google Scholar
• Kreimer AR, Gonzalez P, Katki HA, Porras C, Schiffman M, Rodriguez AC, Solomon D, Jimenez S, Schiller JT, Lowy DR, et al. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncol 2011; 12:862-70; PMID:21865087; http://dx.doi.org/10.1016/S1470-2045(11)70213-3
   PubMed Web of Science ®Google Scholar
• Laurichesse H, Gourdon F, Smits HL, Abdoe TH, Estavoyer JM, Rebika H, Pouliquen P, Catalina P, Dubray C, Beytout J. Safety and immunogenicity of subcutaneous or intramuscular administration of a monovalent inactivated vaccine against Leptospira interrogans serogroup Icterohaemorrhagiae in healthy volunteers. Clin Microbiol Infect 2007; 13:395-403; PMID:17359323; http://dx.doi.org/10.1111/j.1469-0691.2007.01662.x
   PubMed Web of Science ®Google Scholar
• Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007; 356:1928-43; PMID:17494926; http://dx.doi.org/10.1056/NEJMoa061760
   PubMed Web of Science ®Google Scholar
• Zhang XF, Fang HH, Zhao J. Evaluation on the safety and immunogenicity of split influenza virus vaccine. Chinese J Planned Immuniz 2005; 11:348-51.
   Google Scholar
• Lu XJ, Zhou WZ, Gu KF, Zhu FC. Evaluation on safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine. J Southeast Univ (Med Sci Edi) 2008; 27:207-11.
   Google Scholar
• Brown L, Cai T, DasGupta A. Interval estimation for a binomial proportion. Stat Sci 2001; 16:101-17.
   Web of Science ®Google Scholar
• Agresti A. Dealing with discreteness: making 'exact' confidence intervals for proportions, differences of proportions, and odds ratios more exact. Stat Methods Med Res 2003; 12:3-21; PMID:12617505; http://dx.doi.org/10.1191/0962280203sm311ra
   PubMed Web of Science ®Google Scholar
• Zhou XH, Li CM, Yang Z. Improving interval estimation of binomial proportions. Philos Trans A Math Phys Eng Sci 2008; 366:2405-18; PMID:18407898; http://dx.doi.org/10.1098/rsta.2008.0037
   PubMed Web of Science ®Google Scholar
• Price RM, Bonett DG. Confidence intervals for a ratio of two independent binomial proportions. Stat Med 2008; 27:5497-508; PMID:18781560; http://dx.doi.org/10.1002/sim.3376
   PubMed Web of Science ®Google Scholar
• Lin CY, Yang MC. Improved exact confidence intervals for the odds ratio in two independent binomial samples. Biom J 2006; 48:1008-19; PMID:17240658; http://dx.doi.org/10.1002/bimj.200510222
   PubMed Web of Science ®Google Scholar
• Borkowf CB. Constructing binomial confidence intervals with near nominal coverage by adding a single imaginary failure or success. Stat Med 2006; 25:3679-95; PMID:16381080; http://dx.doi.org/10.1002/sim.2469
   PubMed Web of Science ®Google Scholar
• Tang ML, Tang NS, Chan IS. Confidence interval construction for proportion difference in small-sample paired studies. Stat Med 2005; 24:3565-79; PMID:16261646; http://dx.doi.org/10.1002/sim.2216
   PubMed Web of Science ®Google Scholar
• Bailar JC. Redefining the Confidence Interval. Human and Ecological Risk Assessment 2005; 11:169-77; http://dx.doi.org/10.1080/10807030590919990
   Web of Science ®Google Scholar
• Reiczigel J. Confidence intervals for the binomial parameter: some new considerations. Stat Med 2003; 22:611-21; PMID:12590417; http://dx.doi.org/10.1002/sim.1320
   PubMed Web of Science ®Google Scholar
• Tobi H, van den Berg PB, de Jong-van den Berg LT. Small proportions: what to report for confidence intervals? Pharmacoepidemiol Drug Saf 2005; 14:239-47; PMID:15719354; http://dx.doi.org/10.1002/pds.1081.
   PubMedGoogle Scholar
• Agresti A, Coull B. Approximate is better than 'exact' for interval estimation of binomial proportions. Am Sta 1998; 52:119-26.
   Web of Science ®Google Scholar
• Tsai WY, Chi Y, Chen CM. Interval estimation of binomial proportion in clinical trials with a two-stage design. Stat Med 2008; 27:15-35; PMID:17566141; http://dx.doi.org/10.1002/sim.2930
   PubMedGoogle Scholar
• Gelman G, Carlin J, Stern H, Rubin D. Bayesian Data Analysis, 2nd edn. London: Chapman & Hall/CRC, 2003.
   Google Scholar
• Ntzoufras I. Bayesain modeling using WinBUGS. New Jersey, USA: John Wiley & Sons, Inc., 2009.
   Google Scholar
• Geurden T, Berkvens D, Geldhof P, Vercruysse J, Claerebout E. A Bayesian approach for the evaluation of six diagnostic assays and the estimation of Cryptosporidium prevalence in dairy calves. Vet Res 2006; 37:671-82; PMID:16777038; http://dx.doi.org/10.1051/vetres:2006029.
   PubMed Web of Science ®Google Scholar
• Geurden T, Claerebout E, Vercruysse J, Berkvens D. Estimation of diagnostic test characteristics and prevalence of Giardia duodenalis in dairy calves in Belgium using a Bayesian approach. Intl J Parasitol 2004; 34:1121-7; PMID:15380683; http://dx.doi.org/10.1016/j.ijpara.2004.05.007.
   PubMedGoogle Scholar
• Dunson DB. Commentary: practical advantages of Bayesian analysis of epidemiologic data. Am J Epidemiol 2001; 153:1222-6; PMID:11415958; http://dx.doi.org/10.1093/aje/153.12.1222
   PubMed Web of Science ®Google Scholar
• Biswas S, Liu D, Lee J, Berry D. Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center. Clin Trials 2009; 6:205-16; PMID:19528130; http://dx.doi.org/10.1177/1740774509104992.
   PubMed Web of Science ®Google Scholar
• Cook J, Wathen JK, Nguyen H. Parameter Solver, Version 2.3 User's Guide 2013. https://biostatistics.mdanderson.org/SoftwareDownload/SingleSoftware.aspx?Software_Id=6 ( accessed 10 February 2015).
   Google Scholar
• Wijeysundera D, Austin P, Hux J, Beattie W, Laupacis A. Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol 2009; 62:13-21; PMID:18947971; http://dx.doi.org/10.1016/j.jclinepi.2008.07.006.
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration. Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines. May 2007. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074794.htm (accessed 10 February 2015).
   Google Scholar
• United States Food and Drug Administration. Guidance for industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. May 2007. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091985.pdf (accessed 10 February 2015).
   Google Scholar
• Efron B. Bayesians, frequentists, and scientists. JASA 2005; 100:1-5; http://dx.doi.org/10.1198/016214505000000033.
   Web of Science ®Google Scholar
• Spiegelhalter D, Thomas A, Best N, Lunn D. WinBUGS Version 1.4.3 User Manual. MRC Biostatistics Unit, 2007. http://www.mrc-bsu.cam.ac.uk/bugs/ (accessed 10 February 2015).
   Google Scholar