@article{01bf02c8771746cda3eaaaaec1c25699,
title = "Biologically plausible and evidence-based risk intervals in immunization safety research",
abstract = "In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety.",
keywords = "Immunization, Methods, Safety, Vaccines",
author = "Ali Rowhani-Rahbar and Klein, {Nicola P.} and Dekker, {Cornelia L.} and Edwards, {Kathryn M.} and Marchant, {Colin D.} and Claudia Vellozzi and Bruce Fireman and Sejvar, {James J.} and Halsey, {Neal A.} and Roger Baxter",
note = "Funding Information: Funding: This study was supported by the Clinical Immunization Safety Assessment Network and Vaccine Safety Datalink through a subcontract with America's Health Insurance Plans under contract 200-2002-00732 from the Centers for Disease Control and Prevention (CDC) . Financial disclosure: Dr. Rowhani-Rahbar receives contract funding from the CDC as salary support through the Vaccine Safety Fellowship program. Dr. Klein receives contract funding from the CDC and research support from GlaxoSmithKline, Merck & Co., Inc., Sanofi Pasteur, Pfizer Inc., Novartis, and MedImmune. Dr. Dekker receives contract funding from the National Institutes of Health (NIH) and the CDC, is compensated for serving on the safety monitoring committees for the HIV Vaccine Trials Network and for Pfizer, and serves on the scientific advisory board of PharmaJet. Dr. Edwards receives contract funding from the NIH and the CDC. Dr. Marchant receives contract funding from the CDC, has performed clinical research for GlaxoSmithKline, Sanofi Pasteur, Merck & Co., Inc., Pfizer Inc., MedImmune, and Novartis, has served as a consultant to GlaxoSmithKline, Sanofi Pasteur, MedImmune, and Novartis, and has given lectures sponsored by GlaxoSmithKline and Sanofi Pasteur. Dr. Halsey receives contract funding from the CDC, is compensated for serving on safety monitoring committees for studies of vaccines for Merck & Co., Inc., and Novartis, has received an honorarium for training and support for travel from Sanofi-MSD, has research grants through Johns Hopkins University for studies of vaccines in Guatemala from Berna and Intercel, and has received support for a study of a Merck & Co., Inc. human papillomavirus vaccine in Peru, but receives no support for the effort in Peru. Dr. Baxter receives contract funding from the CDC and research grants from Sanofi Pasteur, MedImmune, Novartis, GlaxoSmithKline, Pfizer Inc., Protein Sciences, and Merck & Co., Inc. Drs. Vellozzi and Sejvar are employees of the CDC. Copyright: Copyright 2013 Elsevier B.V., All rights reserved.",
year = "2012",
month = dec,
day = "17",
doi = "10.1016/j.vaccine.2012.07.024",
language = "English (US)",
volume = "31",
pages = "271--277",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "1",
}