WHO ICTRP trial

Danish: BCG vaccination og sygelighed blandt danske småbørn. En prospektivt…

EUCTR2010-021979-85-DK · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2010-021979-85-DK
Public title Danish: BCG vaccination og sygelighed blandt danske småbørn. En prospektivt, randomiseret, klinisk lægemiddelafprøvning. English: Bacille Calmette Guérin immunisation at birth and childhood morbidity in Danish children. A prospective, randomised, clinical trial.
Scientific title Danish: BCG vaccination og sygelighed blandt danske småbørn. En prospektivt, randomiseret, klinisk lægemiddelafprøvning. English: Bacille Calmette Guérin immunisation at birth and childhood morbidity in Danish children. A prospective, randomised, clinical trial.
Primary sponsor The Pediatric Clinics, The Juliane Marie Center, The Danish National Hospital "Rigshospitalet"
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Denmark
Conditions The study aims to test the hypothesis of the positive non-specific effect of BCG immunization at birth on early childhood morbidity in a high-income country. MedDRA version: 12.1 Level: LLT Classification code 10054112 Term: Hospitalisation
Interventions Trade Name: BCG Vaccine "SSI" Pharmaceutical Form: Powder for concentrate for solution for infusion CAS Number: 0 Other descriptive name: BCG (BACILLUS CALMETTE-GUÉRIN), LIVE ATTENUATED DANISH STRAIN 1331 Concentration unit: CFU/ml colony…
Registration date Oct 18, 2010
Target size 4000
Secondary IDs 2009-323
Registry page clinicaltrialsregister.eu

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