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Guideline
. 2016 Dec 1;34(49):5998-6006.
doi: 10.1016/j.vaccine.2016.07.032. Epub 2016 Jul 29.

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

Christine E Jones  1 , Flor M Munoz  2 , Hans M L Spiegel  3 , Ulrich Heininger  4 , Patrick L F Zuber  5 , Kathryn M Edwards  6 , Philipp Lambach  7 , Pieter Neels  8 , Katrin S Kohl  9 , Jane Gidudu  10 , Steven Hirschfeld  11 , James M Oleske  12 , Najwa Khuri-Bulos  13 , Jorgen Bauwens  14 , Linda O Eckert  15 , Sonali Kochhar  16 , Jan Bonhoeffer  4 , Paul T Heath  17 ; Brighton Collaboration Immunization in Pregnancy Working Group
Affiliations
Guideline

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

Christine E Jones et al. Vaccine. .

Abstract

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.

Keywords: Adverse event; Clinical trials; Guidelines; Immunization; Pregnancy; Safety; Vaccines.

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Conflict of interest statement

Conflict of interests

PTH is an investigator for clinical trials done on behalf of St Georges, University of London, London, UK, sponsored by vaccine manufacturers. He is a consultant to Novartis and Pfizer on group B streptococcus vaccines but receives no personal funding for this activity. KME has conducted maternal vaccination studies for Group B streptococcal vaccines funded by Novartis, with the funding to her university. PN is working as a regulatory consultant for industry and WHO. For maternal immunization, PN has been consulted by Novartis V&D. The other authors have no conflicts of interest to declare.

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