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LACK OF ASSOCIATION OF KAWASAKI DISEASE AFTER IMMUNIZATION IN A COHORT OF INFANTS FOLLOWED FOR MULTIPLE AUTOIMMUNE DIAGNOSES IN A LARGE, PHASE-4 OBSERVATIONAL DATABASE SAFETY STUDY OF 7-VALENT PNEUMOCOCCAL CONJUGATE VACCINE: LACK OF ASSOCIATION BETWEEN KAWASAKI DISEASE AND SEVEN-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

Center, Kimberly J. MD*; Hansen, John R. BA†; Lewis, Edwin MPH†; Fireman, Bruce H. MA†; Hilton, Betsy MSRN*

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e318196934a
Brief Reports
Abstract

A large-scale, postmarketing observational database safety study was conducted following 7-valent pneumococcal conjugate vaccine (PCV7) licensure. A secondary outcome was the occurrence of predefined diagnoses among PCV7 vaccinees versus historic controls. Forty-two PCV7 recipients and 17 controls were hospitalized for Kawasaki disease (P = 0.012). After adjusting for potential confounding variables, this difference was not significant (P = 0.083). No association between Kawasaki disease and PCV7 was found.

Author Information

From the *Global Medical Affairs, Wyeth Pharmaceuticals, Collegeville, PA; and †Kaiser Permanente Vaccine Study Center, Oakland, CA.

Accepted for publication November 25, 2008.

Supported by Wyeth Pharmaceuticals.

Address for correspondence: Kimberly J. Center, MD, Wyeth Pharmaceuticals, 500 Arcola Road, Collegeville, PA 19426. E-mail: centerk@wyeth.com.

© 2009 Lippincott Williams & Wilkins, Inc.