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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01694108
Other study ID # EudraCT2010-021979-85
Secondary ID
Status Completed
Phase Phase 4
First received September 22, 2012
Last updated December 3, 2015
Start date September 2012
Est. completion date January 2015

Study information

Verified date December 2015
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority The Committee on Health Research Ethics, Copenhagen, Denmark:The Danish Data Protection Agency, Copenhagen, Denmark:The Good Clinical Practise Unit in Copenhagen, Denmark:The Good Clinical Practise Unit in South Denmark, Denmark:The Danish Health and Medicines Authority, Copenhagen, Denmark:EuDraCT, European Union, Europe:
Study type Interventional

Clinical Trial Summary

In high-income societies the use of health care and medication is steadily increasing. Children have high morbidity, many visits at the general practitioner, an increasing number of hospitalisations, and an increasing use of medication. And, when children are ill, someone has to stay home to care for them. An un-explained global increase in the incidence of the allergic diseases eczema, wheezing, asthma and allergies means that 25% of high-income populations are affected. Cheap preventive measures are highly warranted. Recent studies have shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG) immunisation on neonatal mortality in low-income countries and suggested a positive, non-specific effect on allergic disease in high-income countries. "Non-specific" means that the vaccine effect goes beyond prevention of the targeted disease, i.e. the BCG vaccine benefits the health status of the immunised individual in ways unrelated to protection against tuberculosis (TB). For instance, in a recent randomised trial in West Africa the investigators showed that the BCG vaccine at birth was safe in low birth weight (LBW) infants and significantly reduced neonatal mortality in these children, with a significant long-lasting effect on infant mortality in the smallest newborns with a birth weight <1.5 kg. There is an urgent need to explore the huge potential of the BCG's beneficial immune-stimulatory effects among children in high-income populations.

Therefore, the investigators will carry out a large prospective randomised clinical trial in Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations during early childhood.

Secondary outcomes

1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants.

2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop less eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-eczema/asthma/allergy medication during early childhood than non-BCG-immunised infants.

3. To test the hypothesis that infants who receive the BCG at birth respond in paraclinical measures: Specific IgE, thymic gland size, leucocyte count and differentiation, monocyte memory, cytokine profiles, and antibody titres following immunisation against diphtheria, tetanus, pertussis, pneumococcus, hemophilus.

4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth measures: weight, length and head circumference.

5. To test the hypothesis that infants who get the BCG vaccine at birth respond with decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting, acute otitis media, febrile convulsions.

6. To test the hypothesis that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages and Stages scores.

7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent vaccinations in the Child Vaccination Programme.

8. To test the above mentioned hypotheses specifically in the strata of premature and low-birth-weight Danish infants.


Recruitment information / eligibility

Status Completed
Enrollment 4262
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

- All parents planning to give birth at Rigshospitalet, Hvidovre Hospital and Kolding Hospital will receive at letter during 2nd/3rd trimester of pregnancy with information on the study and be offered inclusion in the study.

Exclusion Criteria:

- Infants born before gestational age 32 weeks and/or birth weight < 1000g, infants with known congenital disease, anomaly or malformation, immune deficiency and HIV, will be excluded. Non-Danish speaking parents will be excluded.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
BCG-vaccine (SSI)


Locations

Country Name City State
Denmark Hvidovre Hospital Copenhagen
Denmark Rigshospitalet Copenhagen Copenhagen Ø
Denmark Kolding Sygehus Kolding

Sponsors (5)

Lead Sponsor Collaborator
Lone Graff Stensballe Danish National Research Foundation, Hvidovre University Hospital, Kolding Sygehus, Research Center for Vitamins and Vaccines (CVIVA)

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative Research From qualitative research in focus groups: parents' attitudes and opinions about letting their child BCG vaccinate.
"Decisional conflict scale" will be used to score and analyse decisional conflicts for both participants and non-participants.
Telephone interview at 3 months of age: The parents' experiences with information given, the vaccination and side effects. From focus group interviews develop and qualify information given to parents before BCG vaccination.
"Decisional conflict scale" to score and analyse the parents decisional conflicts for letting the child vaccinate with di-te-ki-pol/Hib.
0-13 months of age No
Other Communication and Information To test that the use of telephone and internet will be highly acceptable in this young population. To test scores of information, understanding, competence, and voluntariness. 0-13 months of age No
Primary All-cause Hospitalisations To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants. 0-15 months of age No
Secondary Antibiotics To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. 0-2 years of age No
Secondary Eczema To test that Danish infants who get the BCG vaccine at birth develop less eczema at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-eczema medication during early childhood than non-BCG-immunised infants. 0-13 months of age No
Secondary Specific IgE To test that infants who receive the BCG at birth respond in specific IgE. 13 months of age No
Secondary Weight To test that infants who get the BCG vaccine at birth respond in weight. 0-13 months of age No
Secondary Psychomotor Development in Premature Infants To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages and Stages scores. 0-13 months of age Yes
Secondary Vaccination Coverage To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent vaccinations in the Child Vaccination Programme. 0-13 months of age No
Secondary Premature Infants To test the outcome measures specifically in the strata of premature and low-birth-weight Danish infants. 0-2 years of age No
Secondary Asthma To test that Danish infants who get the BCG vaccine at birth develop less asthma at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-asthma medication during early childhood than non-BCG-immunised infants. 0-13 months No
Secondary Food Allergy To test that Danish infants who get the BCG vaccine at birth develop less food allergy at 3 and 12 months of age: self-reported, diagnosed by a physician, or found at clinical examination; and are prescribed less anti-allergy medication during early childhood than non-BCG-immunised infants. 0-13 months No
Secondary Length To test that infants who get the BCG vaccine at birth respond in length. 0-13months No
Secondary Head Circumference To test that infants who get the BCG vaccine at birth respond in head circumference. 0-13months No
Secondary Thymic Gland Size To test that infants who receive the BCG at birth respond in thymic gland size. 0-13 months of age No
Secondary Leucocyte Count and Differentiation To test that infants who receive the BCG at birth respond in leucocyte count and differentiation. 0-13 months of age No
Secondary Monocyte Memory To test that infants who receive the BCG at birth respond in monocyte memory. 0-13 months of age No
Secondary Cytokine Profiles To test that infants who receive the BCG at birth respond in cytokine profiles. 0-13 months of age No
Secondary Antibody Titres Following Immunisation Against Diphtheria, Tetanus, Pertussis, Pneumococcus, Hemophilus To test that infants who receive the BCG at birth respond in antibody titres following immunisation against diphtheria, tetanus, pertussis, pneumococcus, and haemophilus. 0-13 months of age No
Secondary Common Cold To test that Danish infants who get the BCG vaccine at birth develop less common cold at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
Secondary Pneumonia To test that Danish infants who get the BCG vaccine at birth develop less pneumonia at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
Secondary Febrile Episodes To test that Danish infants who get the BCG vaccine at birth develop less febrile episodes at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
Secondary Episodes With Diarrhoea and Vomiting To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
Secondary Acute Otitis Media To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
Secondary Febrile Convulsions To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 3 and 13 months of age than non-BCG-immunised infants. 0-13 months of age No
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