In a multicenter, randomized, placebo-controlled clinical trial of pertussis immune globulin, intravenous (P-IGIV), 25 infants hospitalized with pertussis were enrolled in 24 months (15% of the target sample size) before the study was prematurely terminated because of expiration of the P-IGIV lots and unavailability of additional study product. Although well tolerated, there was no difference in the number or rate of improvement of symptoms (paroxysmal cough, whoop, apnea, bradycardia, oxygen desaturations) in P-IGIV recipients compared with placebo.
From the Departments of *Pediatrics and †Microbiology and Immunology and ¶Mathematics and Statistics, Dalhousie University, Halifax, Nova Scotia, Canada; the ‡Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada; §Le Centre Hospitalier Universitaire de Québec, CHUL, Ste-Foy, Quebec, Canada; and ∥Physio Analytics, Newton, MA.
Accepted for publication September 14, 2006.
Address for correspondence: Dr Scott A. Halperin, Canadian Center for Vaccinology, Halifax, Dalhousie University, IWK Health Centre, 5850/5980 University Avenue, Halifax, NS B3K 6R8 Canada. E-mail: email@example.com.