Biologically plausible and evidence-based risk intervals in immunization safety research

Ali Rowhani-Rahbar, Nicola P. Klein, Cornelia L. Dekker, Kathryn M. Edwards, Colin D. Marchant, Claudia Vellozzi, Bruce Fireman, James J. Sejvar, Neal A Halsey, Roger Baxter

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)271-277
Number of pages7
JournalVaccine
Volume31
Issue number1
DOIs
StatePublished - Dec 17 2012

Fingerprint

Immunization
immunization
Safety
Research
Acute Disseminated Encephalomyelitis
Febrile Seizures
encephalitis
seizures
epidemiological studies
fever
Epidemiologic Studies
clinical trials
Vaccines
vaccines

Keywords

  • Immunization
  • Methods
  • Safety
  • Vaccines

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Rowhani-Rahbar, A., Klein, N. P., Dekker, C. L., Edwards, K. M., Marchant, C. D., Vellozzi, C., ... Baxter, R. (2012). Biologically plausible and evidence-based risk intervals in immunization safety research. Vaccine, 31(1), 271-277. https://doi.org/10.1016/j.vaccine.2012.07.024

Biologically plausible and evidence-based risk intervals in immunization safety research. / Rowhani-Rahbar, Ali; Klein, Nicola P.; Dekker, Cornelia L.; Edwards, Kathryn M.; Marchant, Colin D.; Vellozzi, Claudia; Fireman, Bruce; Sejvar, James J.; Halsey, Neal A; Baxter, Roger.

In: Vaccine, Vol. 31, No. 1, 17.12.2012, p. 271-277.

Research output: Contribution to journalArticle

Rowhani-Rahbar, A, Klein, NP, Dekker, CL, Edwards, KM, Marchant, CD, Vellozzi, C, Fireman, B, Sejvar, JJ, Halsey, NA & Baxter, R 2012, 'Biologically plausible and evidence-based risk intervals in immunization safety research', Vaccine, vol. 31, no. 1, pp. 271-277. https://doi.org/10.1016/j.vaccine.2012.07.024
Rowhani-Rahbar A, Klein NP, Dekker CL, Edwards KM, Marchant CD, Vellozzi C et al. Biologically plausible and evidence-based risk intervals in immunization safety research. Vaccine. 2012 Dec 17;31(1):271-277. https://doi.org/10.1016/j.vaccine.2012.07.024
Rowhani-Rahbar, Ali ; Klein, Nicola P. ; Dekker, Cornelia L. ; Edwards, Kathryn M. ; Marchant, Colin D. ; Vellozzi, Claudia ; Fireman, Bruce ; Sejvar, James J. ; Halsey, Neal A ; Baxter, Roger. / Biologically plausible and evidence-based risk intervals in immunization safety research. In: Vaccine. 2012 ; Vol. 31, No. 1. pp. 271-277.
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