NCT02447536 (BCGSTRAIN) is a Phase 4 clinical trial of BCG-Denmark 1331 (Statens Serum Institute) in Morbidity, sponsored by Bandim Health Project.

Who is sponsoring NCT02447536?

NCT02447536 is sponsored by Bandim Health Project.

What drugs are being tested in NCT02447536?

Interventions in NCT02447536: BCG-Denmark 1331 (Statens Serum Institute), BCG-Russia-I (Serum Institute of India).

What condition does NCT02447536 study?

NCT02447536 studies Morbidity, Bacille Calmette-Guérin.

Is NCT02447536 still recruiting?

NCT02447536 is currently completed. Last updated 16 December 2020.

Last reviewed 2020-12-16 · How we verify

NCT02447536: BCGSTRAIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial of Two Strains of BCG

Completed Phase 4 Last updated 16 December 2020

What this trial tests

Phase 4 trial testing BCG-Denmark 1331 (Statens Serum Institute) in Morbidity in 12,006 participants. Completed in 1 May 2018.

Timeline

8 December 2014

Primary endpoint
24 November 2017

1 May 2018

Quick facts

Lead sponsor	Bandim Health Project
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	12,006
Start date	8 December 2014
Primary completion	24 November 2017
Estimated completion	1 May 2018
Sites	1 location across Guinea-Bissau

Drugs / interventions tested

BCG-Denmark 1331 (Statens Serum Institute) — full drug profile →
BCG-Russia-I (Serum Institute of India) — full drug profile →

Conditions studied

Morbidity — all drugs for Morbidity →
Bacille Calmette-Guérin — all drugs for Bacille Calmette-Guérin →

Sponsor

Bandim Health Project — full company profile →

Who can join

Eligibility, any sex, with Morbidity or Bacille Calmette-Guérin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Early Vaccination With Bacille Calmette-Guérin-Denmark or BCG-Japan Versus BCG-Russia to Healthy Newborns in Guinea-Bissau: A Randomized Controlled Trial.
Schaltz-Buchholzer F, Bjerregaard-Andersen M, Øland CB, Golding C, et al · · 2020 · cited 31× · PMID 31677386 · DOI 10.1093/cid/ciz1080
BCG skin reactions by 2 months of age are associated with better survival in infancy: a prospective observational study from Guinea-Bissau.
Schaltz-Buchholzer F, Berendsen M, Roth A, Jensen KJ, et al · · 2020 · cited 25× · PMID 32978212 · DOI 10.1136/bmjgh-2020-002993

Verify or expand the search:

Other recruiting trials for Morbidity

Currently open trials in the same condition.

NCT07412301 — The Effect of Celiac Axis Stenosis on Morbidity After Pancreatoduodenectomy - A Prospective Study · active not recruiting
NCT06861478 — PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease · Phase 2 · recruiting
NCT06738004 — National Emergency Bariatric Surgery Audit · recruiting

Other Bandim Health Project trials

Trials by the same sponsor.

NCT06266754 — The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau · Phase 4 · unknown
NCT05591339 — Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau · Phase 4 · active not recruiting
NCT04899765 — Measles and BCG Vaccines for Mother and Child · Phase 4 · recruiting
NCT04542330 — Using BCG to Protect Senior Citizens During the COVID-19 Pandemic · Phase 3 · completed
NCT04445428 — OPV as Potential Protection Against COVID-19 · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02447536 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bandim Health Project
Last refreshed: 16 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02447536.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing