MedTrace Logo

Trial to Compare Two Strains of BCG

NCT04383925 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16390

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 BCG-Japan versus BCG-Russia 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 characteristics by six weeks (data collected by telephone) and at two and six months (data collected at home-visits to a subgroup of the cohort).

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 maternal BCG scarring enhances the non-specific effects of BCG.

Conditions

  • Death, Infant
  • Morbidity;Infant

Interventions

BIOLOGICAL

BCG-Japan

Infant (\<1 year) 0.05 ml dose of resuspended BCG-Japan (Tokyo strain 172, Japan BCG Laboratory, 1-5-21 Otsuka, Bunkyo-ku, Tokyo, 112-0012 Japan).

BIOLOGICAL

BCG-Russia

Infant (\<1 year) 0.05 ml dose of resuspended BCG-Russia (Serum Institute of India)

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 · Bandim Health Project, University of Southern Denmark

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
42 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2022-10-30
Completion
2022-12-01

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

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 NCT04383925 on ClinicalTrials.gov