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Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

NCT01229176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-05-01

Study results available
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Summary

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.

Conditions

  • Typhoid Fever

Interventions

BIOLOGICAL

Vi-CRM197 vaccine

BIOLOGICAL

Vi Polysaccharide (PS) vaccine

BIOLOGICAL

Pneumococcal conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • NVGH · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • India
  • Pakistan

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 NCT01229176 on ClinicalTrials.gov