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Trial of Two Strains of BCG

NCT02447536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12006

Last updated 2020-12-16

No results posted yet for this study

Summary

The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life morbidity and mortality, immune responses and adverse events related to BCG vaccination. The primary outcome will be hospital admissions within 6 weeks of age.

Conditions

  • Morbidity
  • Bacille Calmette-Guérin

Interventions

BIOLOGICAL

BCG-Denmark 1331 (Statens Serum Institute)

See above

BIOLOGICAL

BCG-Russia-I (Serum Institute of India)

See above

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, Prof. · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-11-24
Completion
2018-05-01

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 NCT02447536 on ClinicalTrials.gov