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A Randomized Trial of Providing BCG Vaccination Immediately

NCT01989026 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3361

Last updated 2018-06-19

No results posted yet for this study

Summary

Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This effect cannot be explained by prevention of tuberculosis, which is very rare among infants. The protective effect of BCG vaccination is seen already within the first week. It seems that BCG provides a non-specific beneficial immune modulation - thereby reducing overall mortality. Mortality is very high among newborns admitted to the neonatal intensive care unit. If BCG has immediate beneficial effects on the immune system, vaccinating children with BCG as early as possible may save lives. The investigators will test this hypothesis in a randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge (usual practice).

Conditions

  • Early Neonatal Mortality

Interventions

BIOLOGICAL

BCG

Sponsors & Collaborators

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Morten Bjerregaard-Andersen, MD, PhD · Research Center for Vitamins and Vaccines

  • Christine Stabell Benn, MD, PhD, DMSc · Research Center for Vitamins and Vaccines

  • Peter Aaby, Prof, DMSc · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-10-01
Completion
2017-10-01

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Drugs

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 NCT01989026 on ClinicalTrials.gov