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Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy

Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy
Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy
Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy.

The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.
0264-410X
6007-6014
Jones, Christine
48229079-8b58-4dcb-8374-d9481fe7b426
Munoz, Flor
36ec5d14-694c-4a4d-b143-da5a68499096
Kochhar, Sonali
c81a2730-b97d-471e-a617-2902dfa29112
Vergnano, Stefania
0cb6ea76-11e4-411f-95e0-9c0a7bdb24f6
Cutland, Clare L.
f2564b35-6a18-4ea8-875c-d499281cff1c
Steinhoff, Mark
167a2245-21b2-4569-b794-8d87241ac2b5
Blackburn, Steven
9368c6a5-0303-4251-91d6-3dacb8289e50
Heininger, Ulrich
e83c7735-b27c-466e-844f-bc04aec72814
Bonhoeffer, Jan
7e26c742-9be2-49e4-83f2-3c719c79e03a
Heath, Paul T.
b9b6e0e4-6bd0-4c16-b9f6-607b00137fe4
Jones, Christine
48229079-8b58-4dcb-8374-d9481fe7b426
Munoz, Flor
36ec5d14-694c-4a4d-b143-da5a68499096
Kochhar, Sonali
c81a2730-b97d-471e-a617-2902dfa29112
Vergnano, Stefania
0cb6ea76-11e4-411f-95e0-9c0a7bdb24f6
Cutland, Clare L.
f2564b35-6a18-4ea8-875c-d499281cff1c
Steinhoff, Mark
167a2245-21b2-4569-b794-8d87241ac2b5
Blackburn, Steven
9368c6a5-0303-4251-91d6-3dacb8289e50
Heininger, Ulrich
e83c7735-b27c-466e-844f-bc04aec72814
Bonhoeffer, Jan
7e26c742-9be2-49e4-83f2-3c719c79e03a
Heath, Paul T.
b9b6e0e4-6bd0-4c16-b9f6-607b00137fe4

Jones, Christine, Munoz, Flor, Kochhar, Sonali, Vergnano, Stefania, Cutland, Clare L., Steinhoff, Mark, Blackburn, Steven, Heininger, Ulrich, Bonhoeffer, Jan and Heath, Paul T. (2016) Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy. Vaccine, 34 (49), 6007-6014. (doi:10.1016/j.vaccine.2016.07.007).

Record type: Article

Abstract

Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy.

The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.

Full text not available from this repository.

More information

Accepted/In Press date: 16 January 2016
e-pub ahead of print date: 25 October 2016
Published date: 1 December 2016

Identifiers

Local EPrints ID: 416574
URI: https://eprints.soton.ac.uk/id/eprint/416574
ISSN: 0264-410X
PURE UUID: 7ef67922-9748-4979-a59e-f186293eafb7
ORCID for Christine Jones: ORCID iD orcid.org/0000-0003-1523-2368

Catalogue record

Date deposited: 03 Jan 2018 17:30
Last modified: 03 Dec 2019 01:28

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Contributors

Author: Christine Jones ORCID iD
Author: Flor Munoz
Author: Sonali Kochhar
Author: Stefania Vergnano
Author: Clare L. Cutland
Author: Mark Steinhoff
Author: Steven Blackburn
Author: Ulrich Heininger
Author: Jan Bonhoeffer
Author: Paul T. Heath

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