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Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)

NCT01193907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2014-01-17

Study results available
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Summary

This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine

Conditions

  • Typhoid Fever

Interventions

BIOLOGICAL

NVGH Vi-CRM197 12.5 mcg

1 dose of 0.5 mL

BIOLOGICAL

NVGH Vi-CRM197 5.0 mcg

1 dose of 0.5 mL

BIOLOGICAL

NVGH Vi-CRM197 1.25 mcg

1 dose of 0.5 mL

BIOLOGICAL

Vi-polysaccharide vaccine

1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Belgium

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 NCT01193907 on ClinicalTrials.gov