Vaccines: the pentavalent rotavirus vaccine: discovery to licensure and beyond

Clin Infect Dis. 2007 Dec 15;45(12):1618-24. doi: 10.1086/522997.

Abstract

Twenty-five years passed between the discovery of the parent strain (WC3) of the pentavalent human-bovine reassortant rotavirus vaccine (PRV) in 1981 and the licensure of PRV in 2006. This orally administered liquid vaccine, which is given as a 3-dose series, is indicated for the prevention of rotavirus gastroenteritis, caused by the G serotypes contained in the vaccine, in infants and children. PRV is recommended by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics for administration to all infants in the United States. These recommendations are supported by the results of the phase III studies, which demonstrated that PRV is well tolerated and efficacious. PRV reduced rotavirus-related hospitalizations by 96% and was not associated with an increased incidence of serious adverse events, including intussusception. This report focuses on the safety and efficacy data from the late-phase studies of PRV and discusses plans for providing this vaccine to the developing world.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials, Phase III as Topic
  • Developing Countries
  • Drug Approval*
  • Reassortant Viruses / classification
  • Reassortant Viruses / drug effects
  • Reassortant Viruses / immunology
  • Rotavirus / classification
  • Rotavirus / drug effects
  • Rotavirus / immunology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines* / adverse effects
  • Rotavirus Vaccines* / chemistry
  • Serotyping

Substances

  • Rotavirus Vaccines
  • WC3 rotavirus vaccine