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

NCT01123941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

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 a new 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

Typherix

1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide

BIOLOGICAL

NVGH Vi-CRM197

1 dose of 0.5 mL containing 25 mcg of Vi-CRM

Sponsors & Collaborators

Principal Investigators

  • Pierre VanDamme, Dr. · Center for the Evaluation of Vaccination (CEV)

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
2010-05-31
Primary Completion
2010-06-30
Completion
2010-11-30

Countries

  • Belgium

Study Locations

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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 NCT01123941 on ClinicalTrials.gov