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.
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: email@example.com.