Design questions for Streptococcus pneumoniae vaccine trials with a colonisation endpoint.
Vaccine
; 32(1): 159-64, 2013 Dec 17.
Article
en En
| MEDLINE
| ID: mdl-23871614
ABSTRACT
Evaluation of vaccine efficacy for protection against colonisation (VEcol) with Streptococcus pneumoniae and other bacterial pathogens is often based on a cross-sectional study design, in which only one nasopharyngeal sample is obtained per study subject. Here we investigate the feasibility of this study design by investigating a number of practical design problems. Specific questions are related to the timing of colonisation measurement with respect to the time of vaccination, the adjustment for the within-host replacement of vaccine-type colonisation by the non-vaccine type pneumococci, and the impact of multiple serotype colonisation on VEcol estimation. We also discuss the issue of choosing the control vaccine, including comparison of two active pneumococcal vaccines, as well as the sample size and the statistical power of colonisation endpoint trials. In addition, the statistical design with the specific aim to include information about VEcol in the licensure process of new pneumococcal vaccine products is discussed.
Palabras clave
Multiple colonisation; NVT; Nasopharyngeal colonisation; PCV; Pneumococcus; Sample size; VE(T); VE(acq); VE(col); VT; Vaccine efficacy; combined vaccine efficacy against acquisition and duration of colonisation; non-vaccine (sero)type(s); pneumococcal conjugate vaccine; vaccine (sero)type(s); vaccine efficacy against acquisition of colonisation; vaccine efficacy against colonisation
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Infecciones Neumocócicas
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Streptococcus pneumoniae
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Vacunas Neumococicas
Tipo de estudio:
Observational_studies
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Prevalence_studies
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Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Vaccine
Año:
2013
Tipo del documento:
Article