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Shigella WRSS1 Vaccine Trial in Bangladesh

NCT02934178 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-03-31

Study results available
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Summary

This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.

Conditions

Interventions

BIOLOGICAL

Shigella sonnei Strain WRSS1 Vaccine

Live attenuated, oral Shigella WRSS1 vaccine

BIOLOGICAL

Placebo

Sterile saline solution

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Rubhana Raqib, MD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2018-01-10
Completion
2018-01-10
FDA Drug
Yes

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02934178 on ClinicalTrials.gov