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A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults

NCT02676895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-02-18

Study results available
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Summary

The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.

Conditions

  • Shigella Sonnei Infection

Interventions

BIOLOGICAL

GVGH S. sonnei (1790GAHB) vaccine 25 μg

Two injections of the study vaccine were administered 28 days apart.

BIOLOGICAL

GVGH S. sonnei (1790GAHB) vaccine 100 μg

Two injections of the study vaccine were administered 28 days apart.

BIOLOGICAL

Menveo

One injection of Menveo was administered in subjects in the Control Group.

BIOLOGICAL

Boostrix

One injection of Boostrix was administered in subjects in the Control Group.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-08
Primary Completion
2017-03-10
Completion
2017-03-10

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Companies

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 NCT02676895 on ClinicalTrials.gov