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

Anthonet Koen, MBBCh; Lisa Jose, MBBCh; Shabir A. Madhi, PhD; Alan Fix, MD; Stanley Cryz, PhD; Michelle J. Groome, PhD

The Journal of Pediatrics: X (Jan 2019)

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

Anthonet Koen, MBBCh,
Lisa Jose, MBBCh,
Shabir A. Madhi, PhD,
Alan Fix, MD,
Stanley Cryz, PhD,
Michelle J. Groome, PhD

Affiliations

Anthonet Koen, MBBCh: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa
Lisa Jose, MBBCh: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa
Shabir A. Madhi, PhD: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa
Alan Fix, MD: PATH, Washington, DC
Stanley Cryz, PhD: PATH, Washington, DC
Michelle J. Groome, PhD: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa; Reprint requests: Michelle J. Groome, MD, PhD, MRC: Respiratory and Meningeal Pathogens Research Unit, New Nurses Residence, 11th Floor West Wing, Chris Hani Baragwanath Academic Hospital, Chris Hani Road, Soweto, South Africa.

Journal volume & issue: Vol. 1

Abstract

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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.

Published in The Journal of Pediatrics: X

ISSN: 2590-0420 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Pediatrics
Website: https://www.sciencedirect.com/journal/the-journal-of-pediatrics-x

About the journal