Vaccine Response Impaired Clinical Trial
Official title:
A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh
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.
n/a
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