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Evaluating the safety of a rotavirus vaccine: the REST of the story

The Rotavirus Efficacy and Safety Trial (REST) was a blinded, placebo-controlled study of the live pentavalent human-bovine vaccine, RotaTeq® (Merck & Co. Inc., West Point, PA). REST was noteworthy because its primary objective was to evaluate the safety of RotaTeq® with regard to intussusceptio...

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Detalles Bibliográficos
Autores principales: Heyse, Joseph F, Kuter, Barbara J, Dallas, Michael J, Heaton, Penny
Formato: Texto
Lenguaje:English
Publicado: Sage 2008
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2602609/
https://www.ncbi.nlm.nih.gov/pubmed/18375651
http://dx.doi.org/10.1177/1740774508090507
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author Heyse, Joseph F
Kuter, Barbara J
Dallas, Michael J
Heaton, Penny
author_facet Heyse, Joseph F
Kuter, Barbara J
Dallas, Michael J
Heaton, Penny
author_sort Heyse, Joseph F
collection PubMed
description The Rotavirus Efficacy and Safety Trial (REST) was a blinded, placebo-controlled study of the live pentavalent human-bovine vaccine, RotaTeq® (Merck & Co. Inc., West Point, PA). REST was noteworthy because its primary objective was to evaluate the safety of RotaTeq® with regard to intussusception, a rare intestinal illness that occurs with a background incidence of approximately 50 cases per 100 000 infant years. The study involved approximately 70 000 infants at over 500 study sites in 11 countries. The study demonstrated that the risk of intussusception was similar in vaccine and placebo recipients and that the vaccine prevented rotavirus gastroenteritis, ameliorated the severity of disease in those who had any disease, and substantially reduced rotavirus-associated hospitalizations and other health care contacts. This report provides an in-depth review of the background, statistical and regulatory considerations, and execution of REST. We describe the rationale and methods used for sample size, continuous safety monitoring, group sequential design, and detailed study execution. The results of the study have been reported elsewhere. The design and conduct of this study may serve as a useful model for planning other future large-scale clinical trials, especially those evaluating uncommon adverse events.
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spelling pubmed-26026092009-01-26 Evaluating the safety of a rotavirus vaccine: the REST of the story Heyse, Joseph F Kuter, Barbara J Dallas, Michael J Heaton, Penny Clin Trials Design The Rotavirus Efficacy and Safety Trial (REST) was a blinded, placebo-controlled study of the live pentavalent human-bovine vaccine, RotaTeq® (Merck & Co. Inc., West Point, PA). REST was noteworthy because its primary objective was to evaluate the safety of RotaTeq® with regard to intussusception, a rare intestinal illness that occurs with a background incidence of approximately 50 cases per 100 000 infant years. The study involved approximately 70 000 infants at over 500 study sites in 11 countries. The study demonstrated that the risk of intussusception was similar in vaccine and placebo recipients and that the vaccine prevented rotavirus gastroenteritis, ameliorated the severity of disease in those who had any disease, and substantially reduced rotavirus-associated hospitalizations and other health care contacts. This report provides an in-depth review of the background, statistical and regulatory considerations, and execution of REST. We describe the rationale and methods used for sample size, continuous safety monitoring, group sequential design, and detailed study execution. The results of the study have been reported elsewhere. The design and conduct of this study may serve as a useful model for planning other future large-scale clinical trials, especially those evaluating uncommon adverse events. Sage 2008 /pmc/articles/PMC2602609/ /pubmed/18375651 http://dx.doi.org/10.1177/1740774508090507 Text en © Society for Clinical Trials 2008 http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Design
Heyse, Joseph F
Kuter, Barbara J
Dallas, Michael J
Heaton, Penny
Evaluating the safety of a rotavirus vaccine: the REST of the story
title Evaluating the safety of a rotavirus vaccine: the REST of the story
title_full Evaluating the safety of a rotavirus vaccine: the REST of the story
title_fullStr Evaluating the safety of a rotavirus vaccine: the REST of the story
title_full_unstemmed Evaluating the safety of a rotavirus vaccine: the REST of the story
title_short Evaluating the safety of a rotavirus vaccine: the REST of the story
title_sort evaluating the safety of a rotavirus vaccine: the rest of the story
topic Design
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2602609/
https://www.ncbi.nlm.nih.gov/pubmed/18375651
http://dx.doi.org/10.1177/1740774508090507
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