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Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine

NCT00126217 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2871

Last updated 2008-10-21

No results posted yet for this study

Summary

BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity and mortality in a randomised prospective study of revaccination versus no revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that revaccination with BCG reduces childhood mortality after 19 months of age by 30%.

Conditions

Interventions

BIOLOGICAL

Bacille Calmette Guerin (BCG)

0,1 ml, revaccination at 19 months of age

Sponsors & Collaborators

  • International Cooperation with Developing Countries

    collaborator OTHER

  • Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland

    collaborator OTHER

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2006-05-31
Completion
2006-09-30

Countries

  • Guinea-Bissau

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 NCT00126217 on ClinicalTrials.gov