Rotavirus vaccine, live, oral, pentavalent

(RotaTeq®)

Rotavirus vaccine, live, oral, pentavalent

Drug updated on 11/5/2024

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

Indication

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

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Summary
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  • This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-15]
  • Rotavirus vaccines, such as RotaTeq and Rotarix, showed a reduction in hospitalizations due to rotavirus gastroenteritis in children under 5, with a median incidence rate ratio of 0.60 (IQR (interquartile range): 0.40-0.87) among unvaccinated children.
  • In high-mortality countries, Rotarix and RotaTeq reduced severe rotavirus gastroenteritis cases by 63%-86% in children under 12 months and 54%-86% in children aged 12-23 months.
  • Vaccine effectiveness varied by rotavirus genotype, with lower efficacy observed against fully heterotypic genotypes, such as G2P[4].
  • In adjusted indirect comparisons, RotaTeq and Rotarix demonstrated similar effectiveness, with Rotarix reducing severe rotavirus gastroenteritis by 93% in low-mortality countries and RotaTeq achieving a 97% reduction.
  • No increased risk of serious adverse events, including intussusception, was identified with the use of Rotarix, RotaTeq, Rotasiil, or Rotavac. Additionally, no significant association with autoimmune disorders, such as Type 1 Diabetes or celiac disease, was found in rotavirus-vaccinated populations.
  • In high child mortality settings, intussusception risk remained rare and was not significantly higher in vaccinated children compared to those receiving a placebo.
  • Rotavirus vaccines demonstrated lower effectiveness in high-mortality settings but maintained significant protection, with higher effectiveness observed in children under 12 months compared to those aged 12-23 months. Effectiveness also varied geographically, being reduced in regions with high genotype diversity, particularly against heterotypic genotypes such as G2P[4].

Product Monograph / Prescribing Information

Document TitleYearSource
RotaTeq (rotavirus vaccine, live, oral, pentavalent) Prescribing Information.2023Merck & Co., Inc., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Indirect protection from rotavirus vaccines: a systematic review2024Expert Review Of Vaccines
Systematic review of rotavirus vaccination cost-effectiveness in high income settings utilising dynamic transmission modelling techniques2023Vaccine
Monovalent Rotavirus Vaccine Efficacy Against Different Rotavirus Genotypes: A Pooled Analysis of Phase II and III Trial Data2023Clinical Infectious Diseases : An Official Publication Of The Infectious Diseases
Systematic review of the effect of additional doses of oral rotavirus vaccine on immunogenicity and reduction in diarrhoeal disease among young children2022Eclinicalmedicine
Rotavirus vaccination and the risk of type 1 diabetes and celiac disease: A systematic review and meta-analysis2022Frontiers In Pediatrics
Global Estimates of Rotavirus Hospitalizations Among Children Below 5 Years in 2019 and Current and Projected Impacts of Rotavirus Vaccination2022Journal Of The Pediatric Infectious Diseases Society
A systematic review of economic evaluations of vaccines in Middle East and North Africa countries: is existing evidence good enough to support policy decision-making?2021Expert Review Of Pharmacoeconomics & Outcomes Research
15-year experience with rotavirus vaccination in Mexico: a systematic literature review2021Human Vaccines & Immunotherapeutics
Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-analysis2021Vaccine
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 Studies2021Jama Pediatrics
A decade of rotavirus vaccination in Africa - Saving lives and changing the face of diarrhoeal diseases: Report of the 12(th) African Rotavirus Symposium2021Vaccine
Effectiveness of the oral human attenuated pentavalent rotavirus vaccine (RotaTeq) postlicensure: a meta-analysis-2006-20202021Expert Review Of Vaccines
Vaccines for preventing rotavirus diarrhoea: vaccines in use2021The Cochrane Database Of Systematic Reviews
Real-world effectiveness of rotavirus vaccines, 2006-19: a literature review and meta-analysis2020The Lancet. Global Health
Evidence of rotavirus vaccine impact in sub-Saharan Africa: Systematic review and meta-analysis2020Plos One

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