title: Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.
abstract: 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.
authors.affiliation: The Jenner Institute; University of Oxford; Oxford, UK.
authors.forename: Rosalind
authors.initials: R
authors.lastname: Rowland
authors.forename: Geraldine A
authors.initials: GA
authors.lastname: O'Hara
authors.forename: Matthew
authors.initials: M
authors.lastname: Hamill
authors.forename: Ian D
authors.initials: ID
authors.lastname: Poulton
authors.forename: Hannah
authors.initials: H
authors.lastname: Donaldson
authors.forename: Laura
authors.initials: L
authors.lastname: Dinsmore
authors.forename: Timothy
authors.initials: T
authors.lastname: James
authors.forename: Eleanor
authors.initials: E
authors.lastname: Barnes
authors.forename: Paul
authors.initials: P
authors.lastname: Klenerman
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Gilbert
authors.forename: Adrian V S
authors.initials: AV
authors.lastname: Hill
authors.forename: Brian
authors.initials: B
authors.lastname: Shine
authors.forename: Helen
authors.initials: H
authors.lastname: McShane
mesh_terms: D000293:Adolescent; D000328:Adult; D019411:Clinical Laboratory Techniques; D002986:Clinical Trials as Topic; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D018579:Patient Selection; D012189:Retrospective Studies; D006113:United Kingdom; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: D014612:Vaccines
keywords: candidate vaccines; clinical trials; haematological and biochemical reference intervals; healthy young adult subjects; pre-and post-intervention safety analysis