Drug updated on 5/17/2024
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
- 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 Title | Year | Source |
---|---|---|
RotaTeq (rotavirus vaccine, live, oral, pentavalent) Prescribing Information. | 2023 | Merck Sharp & Dohme LLC., Rahway, NJ |