Document Detail


TDM Journal Club: Safety and Immunogenicity of Tetanus Diphteria and Acellular Pertussis Immunization During Pregnancy.
MedLine Citation:
PMID:  25271727     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
This TDM Journal Club aims to appraise the manuscript published by Munoz et al., (2014) and to debate its ability to inform clinical practice. The phase 1-2, randomized (ratio 2:1) double-blind controlled trial conducted by the authors from 2008 to 2012 included 48 pregnant women aged 18 to 45 years who received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum. However, the methodology was not conceived to assess either safety or efficacy as a phase 1-2 study should do. It was not powered to a specific hypothesis and the validity of the results raises concern. This study does not add valuable information to the field of pertussis prevention.
Authors:
Tom Leibson; Maude St-Onge; Gideon Koren
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-9-29
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  -     ISSN:  1536-3694     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2014 Sep 
Date Detail:
Created Date:  2014-10-1     Completed Date:  -     Revised Date:  2014-10-2    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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