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Trial to Compare BCG-Bulgaria and BCG-Denmark

NCT05397678 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15000

Last updated 2024-01-22

No results posted yet for this study

Summary

The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics.

As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.

Conditions

  • Death; Neonatal
  • Death, Infant
  • Morbidity;Newborn
  • Morbidity;Infant
  • Non-specific Effects of Vaccines

Interventions

BIOLOGICAL

BCG-Denmark

AJ vaccines, Copenhagen 1331 strain

BIOLOGICAL

BCG-Bulgaria

BB-NCIPD Ltd., BCG-SL 222 Sofia strain

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, Professor · Bandim Health Project

  • Christine Stabell Benn, Professor · University of Southern Denmark and Bandim Health Project

  • Frederik Schaltz-Buchholzer, MD, PhD · University of Southern Denmark and Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-21
Primary Completion
2024-07-31
Completion
2024-10-31

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 NCT05397678 on ClinicalTrials.gov