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Comparative Evaluation of Safety and Immunogenicity of Two Dosages of an Oral Live Attenuated Human Rotavirus Vaccine

Dennehy, Penelope H. MD*; Brady, Rebecca C. MD; Halperin, Scott A. MD; Ward, Richard L. PhD; Alvey, Justin C. MD§; Fischer, Francis H. Jr. MD; Innis, Bruce L. MD; Rathfon, Hal RPh; Schuind, Anne MD; De Vos, Beatrice MD#for the North American Human Rotavirus Vaccine Study Group

The Pediatric Infectious Disease Journal: June 2005 - Volume 24 - Issue 6 - p 481-488
doi: 10.1097/01.inf.0000164763.55558.71
Original Studies

Background: Rotavirus is a major cause of gastroenteritis in children worldwide and is estimated to be responsible for more than 500,000 physician visits, 50,000 hospitalizations and 20 deaths in the United States each year.

Objective: To compare the safety and immunogenicity of 2 dosages of a live attenuated oral monovalent G1 human rotavirus (HRV) vaccine in healthy infants.

Design/Methods: In this randomized, double blind trial conducted in the United States and Canada, 529 healthy infants 5–15 weeks of age received HRV vaccine containing either 105.2 or 106.4 focus-forming units or placebo. Two doses were administered orally at a 2-month interval concomitantly with routine childhood vaccines. Symptoms of fever, irritability/fussiness, diarrhea, vomiting, loss of appetite and cough/runny nose were solicited for 15 days postvaccination, nonserious adverse events for 43 days postvaccination and serious adverse events throughout the study. Vaccine take was defined as appearance of serum antirotavirus IgA in postimmunization sera at a titer of ≥20 units/mL or vaccine virus shedding in any stool sample collected between the first dose and 2 months after the second dose.

Results: No serious adverse events considered related to vaccine were reported. The incidence of solicited symptoms was similar among treatment groups during the 15-day postvaccination surveillance periods. No significant difference in vaccine take after 2 doses (88.0% in high dose group and 81.5% in low dose group) was seen between vaccine groups (P = 0.153).

Conclusions: Two doses of either dosage level of HRV vaccine administered concurrently with routine childhood vaccines to healthy infants 5–15 weeks of age were well-tolerated and were highly immunogenic.

From the *Division of Pediatric Infectious Diseases, Rhode Island Hospital and the Department of Pediatrics, Brown Medical School, Providence, RI; the †Division of Pediatric Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; the ‡Clinical Trials Research Center, Dalhousie University, IWK Health Centre, Halifax, NS; §Wee Care Pediatrics, Layton, UT; the ∥Holston Medical Group, Chestnut Grove Pediatrics, Kingsport, TN; ¶GlaxoSmithKline Biologicals, King of Prussia, PA; and #GlaxoSmithKline Biologicals, Rixensart, Belgium.

Accepted for publication January 3, 2005.

Supported by GlaxoSmithKline Biologicals.

Address for reprints: Penelope H. Dennehy, MD, Division of Pediatric Infectious Diseases, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903. Fax 401-444-5650; E-mail

© 2005 Lippincott Williams & Wilkins, Inc.