000 02959nam a22003855i 4500
001 u374830
003 SIRSI
005 20160812084254.0
007 cr nn 008mamaa
008 101013s2011 gw | s |||| 0|eng d
020 _a9783642146916
_9978-3-642-14691-6
040 _cMX-MeUAM
050 4 _aQA276-280
082 0 4 _a519.5
_223
100 1 _aNauta, Jozef.
_eauthor.
245 1 0 _aStatistics in Clinical Vaccine Trials
_h[recurso electrónico] /
_cby Jozef Nauta.
264 1 _aBerlin, Heidelberg :
_bSpringer Berlin Heidelberg :
_bImprint: Springer,
_c2011.
300 _aXVIII, 153 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aBasic Concepts of Vaccine Immunology -- Humoral and Cellular Immunity -- Standard Statistical Methods for the Analysis of Immunogenicity Data -- Antibody Titres and Two Types of Bias -- Adjusting for Imbalance in Pre-vaccination State -- Vaccine Equivalence and Non-Inferiority Immunogenicity Trials -- Vaccine Field Efficacy Trials -- Correlates of Protection -- Safety of Vaccines -- Appendices: SAS and Floating Point Format for Calculated Variables -- Closed-Form Solutions for the Constrained ML Estimators Ro -- Simulation Results on Jewell’s Correction for the Rate Ratio -- Proof of Inequality -- A Generalized Worst-Case Sensitivity Analysis for a Single Seroresponse Rate for Which the Confidence Interval Must Fall Above a Pre-Specified Bound.
520 _aThis monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.
650 0 _aStatistics.
650 1 4 _aStatistics.
650 2 4 _aStatistics, general.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783642146909
856 4 0 _zLibro electrónico
_uhttp://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-3-642-14691-6
596 _a19
942 _cLIBRO_ELEC
999 _c202710
_d202710