Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.
Hum Vaccin Immunother
; 9(8): 1741-51, 2013 Aug.
Article
em En
| MEDLINE
| ID: mdl-23733037
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas
/
Ensaios Clínicos como Assunto
/
Seleção de Pacientes
/
Voluntários Saudáveis
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
Europa
Idioma:
En
Revista:
Hum Vaccin Immunother
Ano de publicação:
2013
Tipo de documento:
Article