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EFFICACY AND SAFETY OF PENTAVALENT HUMAN-BOVINE REASSORTANT ROTAVIRUS VACCINE WHEN ADMINISTERED WITH GREATER THAN 10 WEEKS BETWEEN DOSES

Goveia, Michelle G. MD, MPH; Suprun, Leora MSc; Itzler, Robbin F. PhD; McFetridge, Richard BS; Dallas, Michael J. PhD; Kuter, Barbara J. PhD, MPH

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181be6257
Brief Reports
Abstract

The pentavalent human-bovine reassortant rotavirus vaccine is indicated as a 3-dose series with first dose administered orally at 6 to 12 weeks with subsequent doses at 4 to 10 week intervals. In pre-licensure phase III trials, the majority followed this schedule, but there were 2956 instances where infants received a dose of pentavalent human-bovine reassortant rotavirus vaccine/placebo >10 weeks after the previous dose. Among this subset, the efficacy against any severity of disease, the reduction in utilization of healthcare resources and the safety profile after vaccination were comparable with overall results.

Author Information

From the Merck & Co., Inc. West Point, PA.

Accepted for publication August 27, 2009.

Address for correspondence: Michelle Goveia, MD, MPH, Merck & Co., Inc., PO Box 4, West Point, PA 19486. E-mail: michelle_goveia@merck.com.

© 2010 Lippincott Williams & Wilkins, Inc.