NCT00126217

Brief 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%.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,871

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

3.8 years

First QC Date

August 2, 2005

Last Update Submit

October 20, 2008

Conditions

Malaria

Keywords

Non-specific effects of vaccinesInfant mortalityMorbidityLow income countryMalariaBCGimmunisationBCG revaccinationTuberculinMortality

Outcome Measures

Primary Outcomes (3)

  • Mortality till 5 years of age

  • Hospitalisations till 5 years of age

  • Adverse effects within 12 months after intervention

Secondary Outcomes (4)

  • Tuberculin reaction 2 months after intervention

  • Scar reaction 2 months after intervention

  • Malaria morbidity/parasitaemia within 12 months after intervention

  • Assessment of antibody and cellular immune responses 18 months after intervention

Study Arms (2)

1

EXPERIMENTAL
Biological: Bacille Calmette Guerin (BCG)

2

NO INTERVENTION

Interventions

Bacille Calmette Guerin (BCG)BIOLOGICAL

0,1 ml, revaccination at 19 months of age

1

Eligibility Criteria

Age19 Months - 24 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • No overt illness

You may not qualify if:

  • PPD reaction \>15mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Apartado 861, Bissau, Guinea-Bissau

Location

MeSH Terms

Conditions

MalariaInfant Death

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Aaby

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

July 1, 2002

Primary Completion

May 1, 2006

Study Completion

September 1, 2006

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

GU(1)