Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method

Details

• Alternative Title:
  Pharmacoepidemiol Drug Saf
• Personal Author:
  Li, Rongxia ; Weintraub, Eric ; McNeil, Michael M. ; Kulldorff, Martin ; Lewis, Edwin M. ; Nelson, Jennifer ; Xu, Stanley ; Qian, Lei ; Klein, Nicola P. ; Destefano, Frank
• Description:
  Purpose:
  
  The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting.
  
  Methods:
  
  Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre-defined sets of conditions or diagnoses. Using a newly developed tree-temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra® (MenACWY-D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18 years who had received MenACWY-D vaccination(s) between 2005 and 2014. The tree-temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY-D at a 0.05 level of significance, adjusted for multiple testing.
  
  Results:
  
  We detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY-D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY-D safety concerns were raised.
  
  Conclusions:
  
  As a pilot study, we demonstrated that the tree-temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine-AE associations within a large health care data network.
  
  
• Keywords:
  Adolescent Adverse Events Bell’s Palsy Child Cohort Studies Databases, Factual Data Mining Electronic Health Records Female Humans Male Menactra Meningococcal Vaccines Pharmacoepidemiology Pharmacovigilance Pilot Projects Post-licensure Software Vaccination

  More +
• Source:
  Pharmacoepidemiol Drug Saf. 27(4):391-397
• Pubmed ID:
  29446176
• Pubmed Central ID:
  PMC10878474
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  27
• Issue:
  4
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:8f0bb46bfb32a1b181ca258527c27e9cba8922739415357b0e92e94fab7de012
• Download URL:
  https://stacks.cdc.gov/view/cdc/149281/cdc_149281_DS1.pdf
• File Type:
  [PDF - 492.47 KB ]