Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting.
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ABSTRACT: Trial registration
ClinicalTrials.gov: NCT02109484.
SUBMITTER: Koen A
PROVIDER: S-EPMC7376988 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
Publications
Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting.
Koen Anthonet A Jose Lisa L Madhi Shabir A SA Fix Alan A Cryz Stanley S Groome Michelle J MJ
The journal of pediatrics: X 20190101
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.<h4>Trial registration</h4>ClinicalTrials.gov: NCT02109484. ...[more]
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