| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5537657 | Vaccine | 2016 | 9 Pages |
Abstract
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.
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Authors
Christine E. Jones, Flor M. Munoz, Hans M.L. Spiegel, Ulrich Heininger, Patrick L.F. Zuber, Kathryn M. Edwards, Philipp Lambach, Pieter Neels, Katrin S. Kohl, Jane Gidudu, Steven Hirschfeld, James M. Oleske, Najwa Khuri-Bulos, Jorgen Bauwens,