MedTrace Logo

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

NCT02992197 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-08-04

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Charles H. Hood Foundation

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • University of Vermont

    lead OTHER

Principal Investigators

  • Benjamin Lee, M.D. · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
15 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2018-06-07
Completion
2018-06-07

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02992197 on ClinicalTrials.gov