At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12,006 enrolled
Drug / intervention
BCG-Denmark 1331 (Statens Serum Institute) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating the Effect of Different BCG Strains on Early Life Hospital Admissions in Guinea-Bissau: A Randomised Trial
In Brief
A Phase 4 clinical trial evaluating BCG-Denmark 1331 (Statens Serum Institute) and BCG-Russia-I (Serum Institute of India) for Morbidity and Bacille Calmette-Guérin. Completed, enrolled 12,006 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbidity, Bacille Calmette-Guérin
CountriesGuinea-Bissau
CollaboratorsStatens Serum Institut
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedMay 2015
Primary CompletionNov 2017
Study CompletionMay 2018
TodayJul 2026
First PostedMay 19, 2015
Enrollment StartDec 8, 2014
Primary CompletionNov 24, 2017
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.1 years ago
Interventions
BCG-Denmark 1331 (Statens Serum Institute)biological
See above
BCG-Russia-I (Serum Institute of India)biological
See above