drugset / Trial / NCT00126217
Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
Phase 4
Terminated
2871 enrolled
Bandim Health Project
International Cooperation with Developing Countries · collabLeiden University Medical Centre, DEPT of Parasitology, Leiden Holland · collabMedical Research Council Unit, The Gambia · collab
RandomizedParallel-groupOpen-labelPrevention
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%.
Timeline
- Start
- 2002-07
- Primary completion
- 2006-05
- Completion
- 2006-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacille Calmette-Guerin | Vaccine | 0.1 ml | — |