Drug updated on 12/11/2024
Dosage Form | Solution (oral; 2 mL) |
Drug Class | Vaccines |
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
- 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 (interquartile range (IQR): 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 Title | Year | Source |
---|---|---|
RotaTeq (rotavirus vaccine, live, oral, pentavalent) Prescribing Information. | 2023 | Merck & Co., Inc., Rahway, NJ |