E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054112 |
E.1.2 | Term | Hospitalisation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
to test the hypothesis of the positive non-specific effect of BCG immunization at birth on early chi |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
A prospective, randomised, clinical trial. |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Included newborn infants randomised to no treatment |
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E.8.3 |
The trial involves single site in the Member State concerned
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E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Study start 2010, inclusion for 1½ year, follow-up until subject age 2 years.
Studiet vil blive monitoreret af GCP enhed og desuden hvert halve år af forskerne i samarbejde med et DSMB. Såfremt BCG har en signifikant negative effekt (p<0.01) eller en signifikant positiv effekt (p<0.001) på den generelle sygelighed (hospitalsindlæggelse og konsultationer) eller på den specifikke sygelighed for astma og eksem vil studiet blive stoppet. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |