Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Jones, Christine E. ; Munoz, Flor M. ; Spiegel, Hans M.L. ; Heininger, Ulrich ; Zuber, Patrick L.F. ; Edwards, Kathryn M. ; Lambach, Philipp ; Neels, Pieter ; Kohl, Katrin S. ; Gidudu, Jane ; Hirschfeld, Steven ; Oleske, James M. ; Khuri-Bulos, Najwa ; Bauwens, Jorgen ; Eckert, Linda O. ; Kochhar, Sonali ; Bonhoeffer, Jan ; Heath, Paul T.
• Corporate Authors:
  The Brighton Collaboration Immunization in Pregnancy Working Group
• Description:
  Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.
• Subjects:
  Clinical Trials As Topic Female Humans Infant Pregnancy Pregnancy Complications, Infectious Statistics As Topic Vaccination Vaccines
• Source:
  Vaccine. 34(49):5998-6006.
• Pubmed ID:
  27481360
• Pubmed Central ID:
  PMC5572188
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Volume:
  34
• Issue:
  49
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:37a4ee9ec5b76da6b743596cc526442f19cfde94b2dbd7fb1944adfcdb9cd5fc
• Download URL:
  https://stacks.cdc.gov/view/cdc/47795/cdc_47795_DS1.pdf
• File Type:
  [PDF - 117.17 KB ]