title: Development, clinical evaluation, and post-licensure impact of RotaTeq, a pentavalent rotavirus vaccine.
abstract: Rotavirus gastroenteritis (RVGE) is the leading cause of severe diarrhea in children worldwide. This paper provides an overview of the development, clinical evaluation, and postlicensure impact of RotaTeq™(Rotavirus Vaccine, Live, Oral, Pentavalent, Merck & Co., Inc.). RotaTeq, an oral vaccine, is uniquely designed to contain five human-bovine reassortant rotavirus strains expressing the human serotypes G1, G2, G3, G4, and P1A[8], which represent the most common human rotavirus serotypes responsible for ∼85% of RVGE worldwide. The development required novel solutions for manufacturing, testing, and formulation for each of the reassortants. In one of the largest vaccine clinical trials conducted, the vaccine was shown to be well tolerated and highly efficacious against severe RVGE. Efficacy has also been demonstrated in lower-income countries. In large U.S. postlicensure studies, there have been no safety signals identified, and RotaTeq has had a significant impact on reducing RVGE and its associated medical costs since licensure in 2006.
authors: Merck & Co., Inc., West Point, Pennsylvania 19486, USA. michelle_goveia@merck.com
authors: Michelle G
authors: MG
authors: Goveia
authors: Max
authors: M
authors: Ciarlet
authors: Katey E
authors: KE
authors: Owen
authors: Colette S
authors: CS
authors: Ranucci
mesh_terms: D000818:Animals; D002417:Cattle; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000266:history / Q000331:legislation & jurisprudence; D049673:History, 20th Century; D006801:Humans; D008004:Licensure; D011358:Product Surveillance, Postmarketing; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000032:analysis / Q000096:biosynthesis* / Q000627:therapeutic use*
chemical_list: D022243:Rotavirus Vaccines