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

ABSTRACT: 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.

SUBMITTER: Koen A 

PROVIDER: S-EPMC7376988 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature