ProspectivePhase 4NCT01694108
Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
A Phase 4 study testing BCG-vaccine (SSI) in people with Prospective and Single-blind, run by Lone Graff Stensballe at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Prospective, Single-blind, Clinical
- What is being tested?
- BCG-vaccine (SSI)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,262 participants
- Where
- 3 sitesDenmark
- Study dates
- Sep 2012to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Rigshospitalet
Copenhagen, Copenhagen Ø, 2100
Hvidovre Hospital
Copenhagen, 2650
Kolding Sygehus
Kolding, 6000
About this study
Official title: Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.
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.
Read more
Secondary outcomes
- 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.
- 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.
- 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.
- To test the hypothesis that infants who get the BCG vaccine at birth respond in growth measures: weight, length and head circumference.
- 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.
- 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.
- 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.
- To test the above mentioned hypotheses specifically in the strata of premature and low-birth-weight Danish infants.
- Conditions
- Prospective, Single-blind, Clinical, Trial, Intervention
- Being tested
- BCG-vaccine (SSI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG-vaccine (SSI)Biological
| Study group | Role | What they receive |
|---|---|---|
| BCG-vaccine (SSI) | Experimental | Children born to mothers, who have accepted to participate, will be randomised to either intervention group or to the control group at birth. Block-randomisation stratified by hospital, gender and gestational age (≥37 weeks of gestation vs. < 37 weeks of gestation) will be performed electronically just before vaccination by the overall study electronic case report system (e-crf).
Children randomised to the BCG vaccination group will receive an intradermal BCG vaccine (Statens Serum Institute "CG vaccine" in the standard dose 0.05 ml in the upper, lateral part of the arm of the child by a specially trained midwife or a study physician. Receives: Biological: BCG-vaccine (SSI) |
| No Intervention | No intervention | Control children will be treated as usual, since no suitable placebo exists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-15 months of age
Secondary outcomes (22)
Antibiotics
To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).
Measured: 0-15 months of age
Atopic Dermatitis
To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using "scoring atopic dermatitis (SCORAD)" or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age.
Measured: 13 months of age
Specific IgE
Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.
Measured: 13 months of age
Standardized Weight at 13 Months
To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Measured: 13 months of age
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: ASQ: Ages and stages questionnaire - a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.
Measured: 13 months of age
DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age
To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.
Measured: 13 months of age
Standardized Weight, Length and Head Circumference of Premature Children at 13 Months
The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Measured: 13 months of age
Episodic Viral Wheeze
Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.
Measured: 13 months
Food Allergy
Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age
Measured: 13 months
Length at 13 Months of Age
To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Measured: 13months
Standardized Head Circumference at 13 Months of Age
To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Measured: 13 months
Thymic Gland Size at 3 Months of Age
To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.
Measured: 3 months of age
Leucocyte Count 4 Days After Randomisation/Vaccination
To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).
Measured: 4 days after randomisation/vaccination within 7 days after birth
Monocyte Count 4 Days After Randomisation/Vaccination
To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).
Measured: 4 days after randomisation/vaccination within 7 days after birth
Interferon Gamma Response
To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.
Measured: 13 months of age
Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL
To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.
Measured: 13 months of age
Number of Events of Common Cold
To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Number of Events of Pneumonia
To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Number of Events of Febrile Episodes
To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Number of Events With Diarrhoea and Vomiting
To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Number of Events of Acute Otitis Media
To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Number of Events of Febrile Convulsions
To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.
Measured: 13 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ProspectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lone Graff Stensballe
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Kolding Sygehus, Danish National Research Foundation, Research Center for Vitamins and Vaccines (CVIVA)
- Responsible party
- Sponsor-investigator, Lone Graff Stensballe, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lone G Stensballe, MD, PhD, Principal investigator, Rigshospitalet. The Danish National Hospital in Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694108
- Sponsor's protocol ID
- EudraCT2010-021979-85
- Status last verified
- Apr 2017
- First submitted
- 22 Sep 2012
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dybdal D, Stensballe LG, Greisen G, Kjaergaard J. Validity of parent-reported weight and length of infants. Dan Med J. 2023 Aug 23;70(9):A11220712.
PubMed 37622649Birk NM, Nissen TN, Ladekarl M, Zingmark V, Kjaergaard J, Jensen TM, Jensen SK, Thostesen LM, Kofoed PE, Stensballe LG, Andersen A, Pryds O, Nielsen SD, Benn CS, Jeppesen DL. The association between Bacillus Calmette-Guerin vaccination (1331 SSI) skin reaction and subsequent scar development in infants. BMC Infect Dis. 2017 Aug 3;17(1):540. doi: 10.1186/s12879-017-2641-0.
PubMed 28774269Stensballe LG, Sorup S, Aaby P, Benn CS, Greisen G, Jeppesen DL, Birk NM, Kjaergaard J, Nissen TN, Pihl GT, Thostesen LM, Kofoed PE, Pryds O, Ravn H. BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial. Arch Dis Child. 2017 Mar;102(3):224-231. doi: 10.1136/archdischild-2016-310760. Epub 2016 Jul 21.
PubMed 27443836Kjaergaard J, Birk NM, Nissen TN, Thostesen LM, Pihl GT, Benn CS, Jeppesen DL, Pryds O, Kofoed PE, Aaby P, Greisen G, Stensballe LG. Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial. Pediatr Res. 2016 Nov;80(5):681-685. doi: 10.1038/pr.2016.142. Epub 2016 Jul 18.
PubMed 27429204Kjaergaard J, Stensballe LG, Birk NM, Nissen TN, Thostesen LM, Pihl GT, Nielsen AV, Kofoed PE, Aaby P, Pryds O, Greisen G. Bacillus Calmette-Guerin vaccination at birth: Effects on infant growth. A randomized clinical trial. Early Hum Dev. 2016 Sep;100:49-54. doi: 10.1016/j.earlhumdev.2016.05.015. Epub 2016 Jul 7.
PubMed 27394195Kjaergaard J, Stensballe LG, Birk NM, Nissen TN, Foss KT, Thostesen LM, Pihl GT, Andersen A, Kofoed PE, Pryds O, Greisen G. Lack of a Negative Effect of BCG-Vaccination on Child Psychomotor Development: Results from the Danish Calmette Study - A Randomised Clinical Trial. PLoS One. 2016 Apr 28;11(4):e0154541. doi: 10.1371/journal.pone.0154541. eCollection 2016.
PubMed 27123570Nissen TN, Birk NM, Kjaergaard J, Thostesen LM, Pihl GT, Hoffmann T, Jeppesen DL, Kofoed PE, Greisen G, Benn CS, Aaby P, Pryds O, Stensballe LG. Adverse reactions to the Bacillus Calmette-Guerin (BCG) vaccine in new-born infants-an evaluation of the Danish strain 1331 SSI in a randomized clinical trial. Vaccine. 2016 May 11;34(22):2477-82. doi: 10.1016/j.vaccine.2016.03.100. Epub 2016 Apr 7.
PubMed 27060379
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.
- ClinicalTrials.gov ID
- NCT01694108
- Acronym / sponsor ID
- EudraCT2010-021979-85
- Conditions
- Prospective, Single-blind, Clinical, Trial, Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,262 participants (actual)
- Lead sponsor
- Lone Graff StensballeUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Kolding Sygehus, Danish National Research Foundation, Research Center for Vitamins and Vaccines (CVIVA)
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 8 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- To test the hypothesis that infants who get the BCG vaccine at birth respond in growth measures: weight, length and head circumference.
- 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.
- 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.
- 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.
- To test the above mentioned hypotheses specifically in the strata of premature and low-birth-weight Danish infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG-vaccine (SSI) | Experimental | Biological: BCG-vaccine (SSI)Children born to mothers, who have accepted to participate, will be randomised to either intervention group or to the control group at birth. Block-randomisation stratified by hospital, gender and gestational age (≥37 weeks of gestation vs. < 37 weeks of gestation) will be performed electronically just before vaccination by the overall study electronic case report system (e-crf). Children randomised to the BCG vaccination group will receive an intradermal BCG vaccine (Statens Serum Institute "CG vaccine" in the standard dose 0.05 ml in the upper, lateral part of the arm of the child by a specially trained midwife or a study physician. |
| No Intervention | No intervention | –Control children will be treated as usual, since no suitable placebo exists. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG-vaccine (SSI) | Biological | BCG-vaccine (SSI) |
Primary outcome
All-cause Hospitalisations
Time frame: 0-15 months of age
To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.
22 secondary outcomes
Antibiotics
Time frame: 0-15 months of age
Atopic Dermatitis
Time frame: 13 months of age
Specific IgE
Time frame: 13 months of age
Standardized Weight at 13 Months
Time frame: 13 months of age
Psychomotor Development in Premature Infants
Time frame: 13 months of age
DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age
Time frame: 13 months of age
Standardized Weight, Length and Head Circumference of Premature Children at 13 Months
Time frame: 13 months of age
Episodic Viral Wheeze
Time frame: 13 months
Food Allergy
Time frame: 13 months
Length at 13 Months of Age
Time frame: 13months
Standardized Head Circumference at 13 Months of Age
Time frame: 13 months
Thymic Gland Size at 3 Months of Age
Time frame: 3 months of age
Leucocyte Count 4 Days After Randomisation/Vaccination
Time frame: 4 days after randomisation/vaccination within 7 days after birth
Monocyte Count 4 Days After Randomisation/Vaccination
Time frame: 4 days after randomisation/vaccination within 7 days after birth
Interferon Gamma Response
Time frame: 13 months of age
Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL
Time frame: 13 months of age
Number of Events of Common Cold
Time frame: 13 months of age
Number of Events of Pneumonia
Time frame: 13 months of age
Number of Events of Febrile Episodes
Time frame: 13 months of age
Number of Events With Diarrhoea and Vomiting
Time frame: 13 months of age
Number of Events of Acute Otitis Media
Time frame: 13 months of age
Number of Events of Febrile Convulsions
Time frame: 13 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37622649Dybdal D, Stensballe LG, Greisen G, Kjaergaard J. Validity of parent-reported weight and length of infants. Dan Med J. 2023 Aug 23;70(9):A11220712.
- Derived from this study: PubMed 28774269Birk NM, Nissen TN, Ladekarl M, Zingmark V, Kjaergaard J, Jensen TM, Jensen SK, Thostesen LM, Kofoed PE, Stensballe LG, Andersen A, Pryds O, Nielsen SD, Benn CS, Jeppesen DL. The association between Bacillus Calmette-Guerin vaccination (1331 SSI) skin reaction and subsequent scar development in infants. BMC Infect Dis. 2017 Aug 3;17(1):540. doi: 10.1186/s12879-017-2641-0.
- Derived from this study: PubMed 27443836Stensballe LG, Sorup S, Aaby P, Benn CS, Greisen G, Jeppesen DL, Birk NM, Kjaergaard J, Nissen TN, Pihl GT, Thostesen LM, Kofoed PE, Pryds O, Ravn H. BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial. Arch Dis Child. 2017 Mar;102(3):224-231. doi: 10.1136/archdischild-2016-310760. Epub 2016 Jul 21.
- Derived from this study: PubMed 27429204Kjaergaard J, Birk NM, Nissen TN, Thostesen LM, Pihl GT, Benn CS, Jeppesen DL, Pryds O, Kofoed PE, Aaby P, Greisen G, Stensballe LG. Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial. Pediatr Res. 2016 Nov;80(5):681-685. doi: 10.1038/pr.2016.142. Epub 2016 Jul 18.
- Derived from this study: PubMed 27394195Kjaergaard J, Stensballe LG, Birk NM, Nissen TN, Thostesen LM, Pihl GT, Nielsen AV, Kofoed PE, Aaby P, Pryds O, Greisen G. Bacillus Calmette-Guerin vaccination at birth: Effects on infant growth. A randomized clinical trial. Early Hum Dev. 2016 Sep;100:49-54. doi: 10.1016/j.earlhumdev.2016.05.015. Epub 2016 Jul 7.
- Derived from this study: PubMed 27123570Kjaergaard J, Stensballe LG, Birk NM, Nissen TN, Foss KT, Thostesen LM, Pihl GT, Andersen A, Kofoed PE, Pryds O, Greisen G. Lack of a Negative Effect of BCG-Vaccination on Child Psychomotor Development: Results from the Danish Calmette Study - A Randomised Clinical Trial. PLoS One. 2016 Apr 28;11(4):e0154541. doi: 10.1371/journal.pone.0154541. eCollection 2016.
- Derived from this study: PubMed 27060379Nissen TN, Birk NM, Kjaergaard J, Thostesen LM, Pihl GT, Hoffmann T, Jeppesen DL, Kofoed PE, Greisen G, Benn CS, Aaby P, Pryds O, Stensballe LG. Adverse reactions to the Bacillus Calmette-Guerin (BCG) vaccine in new-born infants-an evaluation of the Danish strain 1331 SSI in a randomized clinical trial. Vaccine. 2016 May 11;34(22):2477-82. doi: 10.1016/j.vaccine.2016.03.100. Epub 2016 Apr 7.
- Study home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone G Stensballe, MD, PhD principal investigator
Rigshospitalet. The Danish National Hospital in Denmark.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BCG-vaccine (SSI) in people with Prospective and Single-blind, run by Lone Graff Stensballe at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Hospitalisations (time frame: 0-15 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694108, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.