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A Study of MVA85A in Healthy Children and Infants

NCT00679159 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2010-02-09

No results posted yet for this study

Summary

This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10\^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10\^7, 5 x 10\^7 or 1 x 10\^8 pfu.

Participants will be identified from the general population living in Worcester, Western Cape, South Africa

Conditions

Interventions

BIOLOGICAL

MVA85A

Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis

BIOLOGICAL

Prevenar

Streptococcus pneumoniae vaccine

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Helen McShane · University of Oxford

  • Gregory Hussey · University of Cape Town

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT00679159 on ClinicalTrials.gov