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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative
Vaccine, Volume 36, No. 3, Year 2018
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Description
Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs. © 2017
Authors & Co-Authors
Guillard-Maure, Christine
Unknown Affiliation
Elango, Varalakshmi
Unknown Affiliation
Black, Steven B.
Unknown Affiliation
Castro, José Luis
Unknown Affiliation
Bravo-Alcántara, Pâmela
Unknown Affiliation
Weibel, D. M.
Unknown Affiliation
Sturkenboom, M.
Unknown Affiliation
Zuber, Patrick Louis F.
Unknown Affiliation
Kuli-Lito, Georgina
Unknown Affiliation
Gentile, Ángela
Unknown Affiliation
Vizzotti, Carla
Unknown Affiliation
Buttery, Jim P.
Unknown Affiliation
McMinn, Alissa
Unknown Affiliation
Quinn, Julie Anne
Unknown Affiliation
González, Marcela
Unknown Affiliation
Lagos, Rosanna M.
Unknown Affiliation
Zhang, Tao
Unknown Affiliation
Luque, Marco Tulio
Unknown Affiliation
Ravi, Mandyam Dhati
Unknown Affiliation
Karimi, Abdollah Moein
Unknown Affiliation
Mansour Ghanaie, Roxana
Unknown Affiliation
Parvaneh, Nima
Unknown Affiliation
Mamishi, Setareh
Unknown Affiliation
Kompani, Farzad
Unknown Affiliation
Thoon, Koh Cheng
Unknown Affiliation
Cutland, Clare Louise
Unknown Affiliation
Madhi, Shabir A.
Unknown Affiliation
Groome, Michelle J.
Unknown Affiliation
Velaphi, Sithembiso Christopher
Unknown Affiliation
Hwinya, Cleopas
Unknown Affiliation
Díez Domingo, Javier
Unknown Affiliation
Martín-Navarro, Marian
Unknown Affiliation
Pande, Stephen Legesi
Unknown Affiliation
Alaroker, Florence Olwedo Egwau
Unknown Affiliation
Statistics
Citations: 11
Authors: 34
Affiliations: 5
Identifiers
Doi:
10.1016/j.vaccine.2017.07.085
ISSN:
0264410X
Research Areas
Health System And Policy
Maternal And Child Health