Rotavirus vaccine, live, oral, pentavalent



Drug updated on 5/17/2024

Dosage FormSolution (oral; 2 mL)
Drug ClassVaccines
Ongoing and
Completed Studies


  • Indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9.

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  • Rotavirus vaccine, live, oral, pentavalent (RotaTeq) is indicated for the prevention of rotavirus gastroenteritis caused by types G1 through G9. It demonstrates a strong safety profile and effectiveness in preventing severe rotavirus gastroenteritis across diverse population groups and settings.
  • The information was derived from 13 systematic reviews/meta-analyses that focused on the safety and effectiveness of RotaTeq compared to other vaccines such as Rotarix.
  • No evidence was found of horizontal transmission of RotaTeq strains to unvaccinated infants in a limited study environment, which highlights its safety in terms of reducing potential vaccine-derived disease spread among close contact environments.
  • Efficacy appears genotype-dependent with diminished efficacy reported for heterotypic genotypes like G2P[4]. However, how effective RotaTeq is against these genotypes is not specified but this specifies a challenge common to all rotavirus vaccines including both RotaTeq and Rotarix.
  • In high child mortality settings such as parts of Asia and Africa where the disease burden is highest, although less efficacious than lower mortality settings; they significantly reduce severe gastroenteritis episodes without increasing the risk of intussusception, demonstrating critical effectiveness.
  • Additional dose schedules show improved immunogenicity suggesting potential for greater performance, indicating flexibility in dosing for enhanced protection though more data is needed on direct impacts on disease reduction.
  • Meta-analyses find it highly effective, especially in high-income countries, underlining its role in significantly reducing infection rates while stratified analyses highlight the importance of socioeconomic factors, suggesting beneficial effects when implemented effectively.
  • RotaTeq offers similar levels of protection against rotavirus gastroenteritis requiring hospitalization with no significant risk of serious adverse events, easing the pressure on decision-makers regarding vaccination selection.

Product Monograph / Prescribing Information

Document TitleYearSource
RotaTeq (rotavirus vaccine, live, oral, pentavalent) Prescribing Information.2023Merck Sharp & Dohme LLC., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Literature review to identify evidence of secondary transmission of pentavalent human-bovine reassortant rotavirus vaccine (RV5) strains to unvaccinated subjects.2024Vaccine
Monovalent rotavirus vaccine efficacy against different rotavirus genotypes: a pooled analysis of phase II and III trial data.2023Clinical Infectious Diseases
The efficacy and safety of rotavirus vaccines in countries in Africa and Asia with high child mortality.2022Vaccine
Systematic review of the effect of additional doses of oral rotavirus vaccine on immunogenicity and reduction in diarrhoeal disease among young children.2022EClinicalMedicine
Effectiveness of the oral human attenuated pentavalent rotavirus vaccine (RotaTeq™) postlicensure: a meta-analysis—2006–2020.2021Expert Review of Vaccines
Association of rotavirus vaccines with reduction in rotavirus gastroenteritis in children younger than 5 years; a systematic review and meta-analysis of randomized clinical trials and observational studies.2021JAMA Pediatrics
15-year experience with rotavirus vaccination in Mexico: a systematic literature review.2021Human Vaccines and Immunotherapeutics
Rotavirus vaccination in the US: a systematic review of vaccination coverage and completion.2021Human Vaccines and Immunotherapeutics
Real-world effectiveness of rotavirus vaccines, 2006–19: a literature review and meta-analysis.2020The Lancet Global Health
Evidence of rotavirus vaccine impact in sub-Saharan Africa: systematic review and meta-analysis.2020PLOS ONE
Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines.2020Human Vaccines and Immunotherapeutics
Efficacy of live oral rotavirus vaccines by duration of follow-up: a meta-regression of randomised controlled trials.2019The Lancet Infectious Diseases
Vaccines for preventing rotavirus diarrhoea: vaccines in use.2019The Cochrane Database of Systematic Reviews

Clinical Practice Guidelines