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.
journal_name
Vaccinejournal_title
Vaccineauthors
Jones CE,Munoz FM,Spiegel HM,Heininger U,Zuber PL,Edwards KM,Lambach P,Neels P,Kohl KS,Gidudu J,Hirschfeld S,Oleske JM,Khuri-Bulos N,Bauwens J,Eckert LO,Kochhar S,Bonhoeffer J,Heath PT,Brighton Collaboration Immunizatdoi
10.1016/j.vaccine.2016.07.032subject
Has Abstractpub_date
2016-12-01 00:00:00pages
5998-6006issue
49eissn
0264-410Xissn
1873-2518pii
S0264-410X(16)30615-6journal_volume
34pub_type
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