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

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.

doi:10.1016/j.vaccine.2016.07.032

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

Jul 29 2016
By Jones, Christine E. ; Munoz, Flor M. ; Spiegel, Hans M.L. ; ...
http://dx.doi.org/10.1016/j.vaccine.2016.07.032
Source: Vaccine. 34(49):5998-6006.

[PDF-117.17 KB]

English

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Details:

Alternative Title:

Vaccine
Personal Author:

Jones, Christine E. ; Munoz, Flor M. ; Spiegel, Hans M.L. ; Heininger, Ulrich ; Zuber, Patrick L.F. ; ... More +

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. Less -
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:

nihms894716.nxml

bin

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