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Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial

NCT02504203 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2332

Last updated 2022-02-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.

Conditions

  • Infant Mortality
  • BCG

Interventions

BIOLOGICAL

BCG-Denmark 1331 (Statens Serum Institute)

See above

Sponsors & Collaborators

  • Research Center for Vitamins and Vaccines, Statens Serum Institute

    collaborator UNKNOWN

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Sanne M Thysen, MD, PhD · Bandim Health Project

  • Ane B Fisker, MD,PhD · Bandim Health Project

  • Amabelia Rodrigues, PhD · Bandim Health Project

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

  • Peter Aaby, PhD,DMSc · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Guinea-Bissau

Study Locations

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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 NCT02504203 on ClinicalTrials.gov