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Clinical Trial Summary

Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.

Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02992197
Study type Interventional
Source University of Vermont
Contact
Status Completed
Phase Phase 4
Start date June 12, 2017
Completion date June 7, 2018

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