NCT02992197

The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity

A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 15 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Infection
• Vaccine Response Impaired
• Vaccine Virus Shedding

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix, dose 1	Rotarix, dose 1
BIOLOGICAL	Rotarix, dose 2	Rotarix, dose 2
DRUG	Placebo (for Rotarix dose 2)	Sterile water to provide volume equivalent as a second dose of Rotarix

Timeline

• Start date: 2017-06-12
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2016-12-14
• Last updated: 2020-08-04
• Results posted: 2020-07-17

Locations

1 site across 1 country: Bangladesh