Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting

Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants wi...

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Detalles Bibliográficos
Autores principales: Koen, Anthonet, Jose, Lisa, Madhi, Shabir A., Fix, Alan, Cryz, Stanley, Groome, Michelle J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Brief Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376988/
https://www.ncbi.nlm.nih.gov/pubmed/32734176
http://dx.doi.org/10.1016/j.ympdx.2019.100005
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author Koen, Anthonet
Jose, Lisa
Madhi, Shabir A.
Fix, Alan
Cryz, Stanley
Groome, Michelle J.
author_facet Koen, Anthonet
Jose, Lisa
Madhi, Shabir A.
Fix, Alan
Cryz, Stanley
Groome, Michelle J.
author_sort Koen, Anthonet
collection PubMed
description Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants without HIV infection from participation owing to neutropenia. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02109484.
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spelling pubmed-73769882020-07-28 Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting Koen, Anthonet Jose, Lisa Madhi, Shabir A. Fix, Alan Cryz, Stanley Groome, Michelle J. J Pediatr X Brief Reports Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants without HIV infection from participation owing to neutropenia. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02109484. Elsevier 2019-07-18 /pmc/articles/PMC7376988/ /pubmed/32734176 http://dx.doi.org/10.1016/j.ympdx.2019.100005 Text en © 2019 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Brief Reports
Koen, Anthonet
Jose, Lisa
Madhi, Shabir A.
Fix, Alan
Cryz, Stanley
Groome, Michelle J.
Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title_full Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title_fullStr Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title_full_unstemmed Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title_short Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting
title_sort neutrophil counts in healthy south african infants: implications for enrollment and adverse event grading in clinical trials in an african setting
topic Brief Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376988/
https://www.ncbi.nlm.nih.gov/pubmed/32734176
http://dx.doi.org/10.1016/j.ympdx.2019.100005
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