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Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

NCT00242047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2005-10-19

No results posted yet for this study

Summary

An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.

Conditions

Interventions

BIOLOGICAL

Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).

Sponsors & Collaborators

  • Aeras

    collaborator OTHER

  • Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.

    collaborator UNKNOWN

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Gregory Hussey, FCCH · South African Tuberculosis Vaccine Initiative

  • Larry Geiter, PhD · Aeras

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-03-31
Completion
2006-08-31

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 NCT00242047 on ClinicalTrials.gov