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
Conditions
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
Sponsors
The Pediatric Clinics, The Juliane Marie Center, The Danish National Hospital "Rigshospitalet"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Gestationsalder = 32 uger og fødselsvægt = 1000g. • Barnet skønnes at være helt velskabt og fuldt levedygtigt. • Barnet har ingen tegn på medfødt immundefekt. • Skriftligt samtykke fra begge forældre foreligger. Gestational age = 32 weeks and birthweight = 1000 grammes. Healthy newborn. No signs of immunedeficiency. Written consent from both parents. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Alle børn født før 32. gestationsuge og/eller med FV < 1000gram, og børn med kendt immundefekt herunder HIV og kromosomdefekt, ekskluderes. Syge børn med behov for intensiv behandling ekskluderes. Infants born before gestational age 32 weeks and/or birth weight < 1000g, infants with known congenital disease, anomaly or malformation, immune deficiency and HIV, are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that Danish infants who are Bacille Calmette Guérin (BCG) immunised at birth experience less hospitalisations during early childhood than non-BCG-immunised infants. ;Secondary Objective: a. To test the hypothesis that Danish infants who are BCG immunised at birth use less antibiotics during early childhood than non-BCG-immunised infants. b. To test the hypothesis that Danish infants who are BCG immunised at birth develop less atopic disease (eczema, wheeze, asthma, allergy) and use less anti-atopic medication during early childhood than non-BCG-immunised infants. c. To test the abovementioned hypotheses specifically in the strata of premature and low-birth-weight Danish infants. d. To test if the BCG immunised infants develop differences in the paraclinical measures of their immune system measured as leucocyte counts and specific IgE at 3 months of age and as vaccine response at 13 months of age to the difteri and tetanus vaccines gives as part of the Danish Child Immunisation Programme. ;Primary end point(s): To test the hypothesis that Danish infants who are Bacille Calmette Guérin (BCG) immunised at birth experience less hospitalisations during early childhood than non-BCG-immunised infants. | — |
Countries
Denmark
Outcome results
None listed