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Development, clinical evaluation, and post-licensure impact of RotaTeq, a pentavalent rotavirus vaccine.
Ann N Y Acad Sci. 2011 Mar; 1222:14-8.AN

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+Show Affiliations

Merck & Co., Inc., West Point, Pennsylvania 19486, USA. michelle_goveia@merck.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Historical Article
Journal Article
Review

Language

eng

PubMed ID

21434938

Citation

Goveia, Michelle G., et al. "Development, Clinical Evaluation, and Post-licensure Impact of RotaTeq, a Pentavalent Rotavirus Vaccine." Annals of the New York Academy of Sciences, vol. 1222, 2011, pp. 14-8.
Goveia MG, Ciarlet M, Owen KE, et al. Development, clinical evaluation, and post-licensure impact of RotaTeq, a pentavalent rotavirus vaccine. Ann N Y Acad Sci. 2011;1222:14-8.
Goveia, M. G., Ciarlet, M., Owen, K. E., & Ranucci, C. S. (2011). Development, clinical evaluation, and post-licensure impact of RotaTeq, a pentavalent rotavirus vaccine. Annals of the New York Academy of Sciences, 1222, 14-8. https://doi.org/10.1111/j.1749-6632.2011.05970.x
Goveia MG, et al. Development, Clinical Evaluation, and Post-licensure Impact of RotaTeq, a Pentavalent Rotavirus Vaccine. Ann N Y Acad Sci. 2011;1222:14-8. PubMed PMID: 21434938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development, clinical evaluation, and post-licensure impact of RotaTeq, a pentavalent rotavirus vaccine. AU - Goveia,Michelle G, AU - Ciarlet,Max, AU - Owen,Katey E, AU - Ranucci,Colette S, PY - 2011/3/26/entrez PY - 2011/3/26/pubmed PY - 2011/6/8/medline SP - 14 EP - 8 JF - Annals of the New York Academy of Sciences JO - Ann. N. Y. Acad. Sci. VL - 1222 N2 - 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. SN - 1749-6632 UR - https://www.unboundmedicine.com/medline/citation/21434938/Development_clinical_evaluation_and_post_licensure_impact_of_RotaTeq_a_pentavalent_rotavirus_vaccine_ L2 - https://doi.org/10.1111/j.1749-6632.2011.05970.x DB - PRIME DP - Unbound Medicine ER -