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This was a retrospective study to determine the validity of institutional reference intervals for interpreting biochemistry and hematology results in healthy adults in the context of clinical trials of preventive vaccines. An example population of 974 healthy adults participating in clinical trials at the Jenner Institute, Oxford, UK, between 1999 and 2009 was studied. Methods for calculating the central 95% ranges and determining the coefficients of within person variation were demonstrated. Recommendations have been made as to how these data can be usefully applied to the interpretation of blood results in healthy adult subjects for the purposes of clinical trial inclusion decisions and post-vaccination safety monitoring.

Original publication

DOI

10.4161/hv.24998

Type

Journal article

Journal

Hum Vaccin Immunother

Publication Date

08/2013

Volume

9

Pages

1741 - 1751

Keywords

candidate vaccines, clinical trials, haematological and biochemical reference intervals, healthy young adult subjects, pre-and post-intervention safety analysis, Adolescent, Adult, Clinical Laboratory Techniques, Clinical Trials as Topic, Female, Healthy Volunteers, Humans, Male, Patient Selection, Retrospective Studies, United Kingdom, Vaccines, Young Adult