Paul-henri Lambert - Academia.edu (original) (raw)
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UERJ - Universidade do Estado do Rio de Janeiro / Rio de Janeiro State University
UFMG - The Federal University of Minas Gerais
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Papers by Paul-henri Lambert
Vaccine, 2013
Background: The potential for development of autoimmune diseases after vaccination with new vacci... more Background: The potential for development of autoimmune diseases after vaccination with new vaccines containing novel adjuvants is a theoretical concern. Randomised, placebo-controlled trials are the best method for assessing a potential causal relationship between an adverse event and vaccination, but usually have a sample size too small to detect adverse events occurring in <1% of subjects. Incomplete case documentation may hamper definitive diagnoses, preventing accurate causality assessment. To date there are no guidelines for collection, documentation and monitoring of potential immune mediated disorders (pIMD) reported in the course of clinical trials with adjuvanted vaccines. Objective: This paper proposes a methodology for collection of pIMDs in clinical vaccine trials, with the objective of obtaining complete and reliable data using standardised methodology for its collection and analysis.
Vaccine, 2013
Background: The potential for development of autoimmune diseases after vaccination with new vacci... more Background: The potential for development of autoimmune diseases after vaccination with new vaccines containing novel adjuvants is a theoretical concern. Randomised, placebo-controlled trials are the best method for assessing a potential causal relationship between an adverse event and vaccination, but usually have a sample size too small to detect adverse events occurring in <1% of subjects. Incomplete case documentation may hamper definitive diagnoses, preventing accurate causality assessment. To date there are no guidelines for collection, documentation and monitoring of potential immune mediated disorders (pIMD) reported in the course of clinical trials with adjuvanted vaccines. Objective: This paper proposes a methodology for collection of pIMDs in clinical vaccine trials, with the objective of obtaining complete and reliable data using standardised methodology for its collection and analysis.