Trial · NCT01694108
Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
NCT01694108, Phase 4, Completed, Lone Graff Stensballe; results first posted 2016-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. Trials, record NCT01694108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01694108
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
- NCT number
- NCT01694108
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,262 participants, actual
- Lead sponsor
- Lone Graff Stensballe
- Conditions
- Prospective, Single-blind, Clinical, Trial, Intervention
- Interventions
- BCG-vaccine (SSI)
- First posted
- 2012-09-26
- Last updated
- 2017-05-24
- Results first posted
- 2016-01-08
- Limitations and caveats
- The allocation was planned to be stratified by sex, study site, and prematurity, however, due to a programming error the allocation was stratified only by prematurity.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Hospitalisations | 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. |
| Secondary | Antibiotics | 0-15 months of age | 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). |
| Secondary | Atopic Dermatitis | 13 months of age | 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. |
| Secondary | Specific IgE | 13 months of age | Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35. |
| Secondary | Standardized Weight at 13 Months | 13 months of age | 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. |
| Secondary | Psychomotor Development in Premature Infants | 13 months of age | 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. |
| Secondary | DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age | 13 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. |
| Secondary | Standardized Weight, Length and Head Circumference of Premature Children at 13 Months | 13 months of age | 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. |
| Secondary | Episodic Viral Wheeze | 13 months | Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview. |
| Secondary | Food Allergy | 13 months | Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Hospitalisations | 0-15 months of age | Intention-to-treat | Events | NUMBER |
| SECONDARY | Antibiotics | 0-15 months of age | Intention-to-treat | participants | NUMBER |
| SECONDARY | Atopic Dermatitis | 13 months of age | This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%. | participants | NUMBER |
| SECONDARY | Specific IgE | 13 months of age | This analysis includes children who participated with blood samples for this sub-study regarding specific IgE. | participants | NUMBER |
| SECONDARY | Standardized Weight at 13 Months | 13 months of age | This analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%. | Weight z-score at 13 months | MEAN |
| SECONDARY | Psychomotor Development in Premature Infants | 13 months of age | This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%. | Score on ASQ scale | MEAN |
| SECONDARY | DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age | 13 months of age | Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine. | participants | NUMBER |
| SECONDARY | Standardized Weight, Length and Head Circumference of Premature Children at 13 Months | 13 months of age | Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%. | z-score | MEAN |
| SECONDARY | Episodic Viral Wheeze | 13 months | This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%. | participants | NUMBER |
| SECONDARY | Food Allergy | 13 months | This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%. | participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Hospitalisations | BCG-vaccine | 637 | Events | ||
| All-cause Hospitalisations | Control Children (no Intervention) | 633 | Events | ||
| Antibiotics | BCG-vaccine | 934 | participants | ||
| Antibiotics | Control Children | 931 | participants | ||
| Atopic Dermatitis | BCG-vaccine | 466 | participants | ||
| Atopic Dermatitis | Control Children | 495 | participants | ||
| Specific IgE | BCG-vaccine | 55 | participants | ||
| Specific IgE | Control Children | 50 | participants | ||
| Standardized Weight at 13 Months | BCG-vaccine | 0.58 | Standard Deviation 0.90 | Weight z-score at 13 months | |
| Standardized Weight at 13 Months | Control Children | 0.61 | Standard Deviation 0.94 | Weight z-score at 13 months |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BCG-vaccine | 2,129 | |
| Overall Study | STARTED | Control Children (no Intervention) | 2,133 | |
| Overall Study | COMPLETED | BCG-vaccine | 2,129 | |
| Overall Study | COMPLETED | Control Children (no Intervention) | 2,133 | |
| Overall Study | NOT COMPLETED | BCG-vaccine | 0 | |
| Overall Study | NOT COMPLETED | Control Children (no Intervention) | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | BCG-vaccine related event | Infections and infestations | BCG-vaccine | 212 | 2,129 | 212 |
| other | BCG-vaccine related event | Infections and infestations | Control Children (no Intervention) | 0 | 2,133 | 0 |
| other | Other than BCG-vaccine related | General disorders | BCG-vaccine | 21 | 2,129 | 2,129 |
| other | Other than BCG-vaccine related | General disorders | Control Children (no Intervention) | 123 | 2,133 | 2,133 |
| serious | Dead | General disorders | BCG-vaccine | 3 | 2,129 | 3 |
| serious | Dead | General disorders | Control Children (no Intervention) | 1 | 2,133 | 1 |
| serious | Other than dead | General disorders | BCG-vaccine | 62 | 2,129 | 62 |
| serious | Other than dead | General disorders | Control Children (no Intervention) | 44 | 2,133 | 44 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BCG-vaccine | ||
| Total, all-cause mortality | Control Children (no Intervention) | ||
| Total, other adverse events | BCG-vaccine | 233 | 2,129 |
| Total, other adverse events | Control Children (no Intervention) | 123 | 2,133 |
| Total, serious adverse events | BCG-vaccine | 65 | 2,129 |
| Total, serious adverse events | Control Children (no Intervention) | 45 | 2,133 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BCG-vaccine vs Control Children: Atopic Dermatitis | Trial comparisons |
| BCG-vaccine vs Control Children: Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL | Trial comparisons |
| BCG-vaccine vs Control Children: Interferon Gamma Response | Trial comparisons |
| BCG-vaccine vs Control Children: DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age | Trial comparisons |
| BCG-vaccine vs Control Children: Food Allergy | Trial comparisons |
| BCG-vaccine vs Control Children: Episodic Viral Wheeze | Trial comparisons |
| BCG-vaccine vs Control Children: Specific IgE | Trial comparisons |
| BCG-vaccine vs Control Children: Antibiotics | Trial comparisons |
| BCG-vaccine vs Control Children (no Intervention): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01694108
GET https://conductscience.org/api/trials/v1/NCT01694108/registered?page=2