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

NCT01437267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-04-10

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 children and infants from various age groups in the Philippines 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

Pneumococcal conjugate vaccine

BIOLOGICAL

Vi Polysaccharide (PS) vaccine

Sponsors & Collaborators

Principal Investigators

  • Maria Rosario Z Capeding, MD · Research Institute for Tropical Medicine (RITM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Philippines

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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 NCT01437267 on ClinicalTrials.gov