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Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?

NCT00146302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2320

Last updated 2012-03-19

No results posted yet for this study

Summary

The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks. Due to difficulties in establishing the correct gestational age, the vaccination policy for BCG in many developing countries is defined by birth weight rather than by gestational maturity. In the study area, low birth weight (LBW) infants (\< 2500 g) are not supposed to be vaccinated at birth; instead the mother is asked to return for vaccination when the child has gained sufficient weight. 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 early vaccination of LBW children for adverse events, purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity, and mortality in a randomised prospective study of BCG vaccination at birth versus later (according to policy) among children 19 months of age in Guinea-Bissau. The hypothesis is that BCG vaccination of low birth weight (LBW) children at birth reduces infant mortality of this high-risk group by 25%.

Conditions

Interventions

BIOLOGICAL

Bacille Calmette Guerin (BCG)

Sponsors & Collaborators

  • International Cooperation with Developing Countries

    collaborator OTHER

  • March of Dimes

    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

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

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 NCT00146302 on ClinicalTrials.gov