AllergyPhase 3MIS BAIRNCT01906853

Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction

A Phase 3 study testing BCG in people with Allergy and Eczema, run by Murdoch Childrens Research Institute at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life. 2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG… Read more about this study

Who is it for?: Ages Up to 10 daysHealthy volunteers can take part
Conditions the study is for: Allergy, Eczema, Respiratory Tract Infections
What is being tested?: BCG
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,272 participants
Where: 2 sitesAustralia
Study dates: Jul 2013to Feb 2025
Phase: Phase 3
Are there results?: None posted in the registry

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 10 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Less than 10 days old;
English speaking mother;
An informed consent form must be signed and dated by their parent(s) or legally acceptable representative after the nature of the study has been explained and prior to any study assessments/procedures;
The infant's mother has screened negative for HIV during this pregnancy;
Born no earlier than eight weeks before estimated date of delivery;
Birth weight >1500g.
The legal guardian expects to be able to complete four online/phone questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing at RCH between 12-16 months of age.

Who cannot join

Any indication for BCG immunisation in the first 12 months of life including:
likely travel to a high tuberculosis (TB) incidence country in the first year of life.
Aboriginal and Torres Strait Islander babies living in parts of Australia where the incidence of TB is higher
newborn babies, if either parent has leprosy or a family history of leprosy
newborn in contact with a patient with TB.
Known or suspected HIV infection

Show all 18Show fewer

Treatment with corticosteroids or other immunosuppressive therapy, including monoclonal antibodies against tumour necrosis factor-alpha (TNF-alpha) (e.g. infliximab, etanercept, adalimumab).
Born to a mother treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies) in the 3rd trimester;
Congenital cellular immunodeficiencies including specific deficiencies of the interferon gamma pathway;
Malignancies involving bone marrow or lymphoid systems;
Serious underlying illness including severe malnutrition;
Medically unstable;
Generalised septic skin disease and skin conditions such as eczema, dermatitis and psoriasis;
Significant febrile illness;
Mother immunosuppressed;
Family history of immunodeficiency;
Consanguineous parents;
Multiple births more than twins.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Mercy Hospital for Women
Heidelberg, Victoria, 3084
Royal Children's Hospital
Melbourne, Victoria, 3052

Other trials in Australia

About this study

Official title: A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants

To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life.
To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.

Read the detailed description

There has been a dramatic rise in allergic diseases worldwide since the 1980s. Asthma rates increased first, followed by eczema, allergic rhinitis and, more recently, food allergy - especially in infants and young children. In Australia, the prevalence of allergic disease is particularly high: up to 30% of children are affected, and eczema and asthma are among the most common chronic diseases of childhood.

Preventing allergic disease by an immunomodulatory intervention early in life would be a major advance with significant implications for individual health and public health resources. Bacillus Calmette-Guérin (BCG) immunisation is a potential intervention with an established safety profile. This vaccine has powerful non-specific effects on the cellular immune response that potentially prime host immunity away from an allergic pathway. Observational data and one small randomised controlled trial (RCT) suggest that BCG immunisation at birth leads to a substantial reduction in allergic disease - however, there is an absence of level 1 evidence.

Conditions: Allergy, Eczema, Respiratory Tract Infections
Being tested: BCG
Keywords: BCG, Bacille Calmette Guérin, Allergy, Immunity, Immune response, Vaccine, Infants, Children, Infection
Medical subject headings: Hypersensitivity, Eczema, Respiratory Tract Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCGBiological
Also called BCG vaccine - Denmark strain, BCG Denmark, Statens Serum Institute BCG vaccine, Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331

Study groups in NCT01906853
Study group	Role	What they receive
No BCG	No intervention	No BCG
BCG	Experimental	Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331 Receives: Biological: BCG

What is being measured

The primary outcome is the main question the study is designed to answer.

Atopic sensitisation measured by skin prick test (SPT)
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Measured: 1 year of age
Atopic sensitisation measured by skin prick test (SPT)
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Measured: 5 years of age
Lower respiratory tract infection (LRTI)
Measured by parent report
Measured: 0-12 months
Lower respiratory tract infection (LRTI) hospital admissions
Proportion of participants with ≥1 hospital admission for LRTI reported by parent
Measured: 0-5 years of age
Eczema ever
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Measured: 0-12 months
Eczema ever
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Measured: 0-5 years of age
Current asthma
Using ISAAC definitions
Measured: 5 years of age
Asthma ever
Using ISAAC definitions
Measured: 5 years of age

Secondary outcomes (51)

Clinical food allergy
Proportion of participants with challenge-proven food allergy OR convincing history of food allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food allergens
Measured: 1 year of age
Clinical food allergy
Proportion of participants with challenge-proven food allergy OR convincing history of food allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food allergens
Measured: 5 years of age
Atopic sensitisation measured by SPT using a more stringent cut-off
Proportion of participants with a positive SPT defined as wheal diameter ≥3 mm greater than negative control at 15 min to one or more of a panel of food allergens and aeroallergens
Measured: 1 year of age
Atopic sensitisation measured by SPT using a more stringent cut-off
Proportion of participants with a positive SPT defined as wheal diameter ≥3 mm greater than negative control at 15 min to one or more of a panel of food allergens and aeroallergens
Measured: 5 years of age
Atopic sensitisation to multiple allergens measured by SPT
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to two or more of a panel of food allergens and aeroallergens
Measured: 1 year of age
Atopic sensitisation to multiple allergens measured by SPT
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to two or more of a panel of food allergens and aeroallergens
Measured: 5 years of age
Parent report of food allergy
Proportion of participants with an allergic reaction to any food reported by parent
Measured: 0-12 months of age
Parent report of food allergy
Proportion of participants with an allergic reaction to any food reported by parent
Measured: 0-5 years of age
Egg sensitisation
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to egg allergen
Measured: 1 year of age
Egg sensitisation
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to egg allergen
Measured: 5 years of age
Egg allergy
Proportion of participants with a challenge-proven egg allergy OR convincing history of egg allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to egg
Measured: 1 year of age
Egg allergy
Proportion of participants with a challenge-proven egg allergy OR convincing history of egg allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to egg
Measured: 5 years of age
Atopic wheeze
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens together with parent-reported wheeze
Measured: 1 year of age
Atopic wheeze
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens together with parent-reported wheeze
Measured: 5 years of age
Lower respiratory tract infection (LRTI)
Proportion of participants with ≥1 episode of LRTI, by parental report
Measured: Prior to first Diphtheria, Tetanus, Pertussis (DTP) vaccination
Lower respiratory tract infection (LRTI)
Proportion of participants with ≥1 episode of LRTI, by parental report
Measured: 0-5 years of age
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Measured: 0-12 months
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Measured: Prior to first DTP vaccination
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Measured: 0-5 years of age
Infections
Hospital admissions for any infection by parental report
Measured: 0-12 months
Infections
Hospital admissions for any infection by parental report
Measured: Prior to first DTP vaccination
Infections
Hospital admissions for any infection by parental report
Measured: 0-5 years of age
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Measured: 0-12 months of age
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Measured: Prior to first DTP vaccination
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Measured: 0-5 years of age
Rate of any infection
Number of clinical episodes of where an infant had symptoms of: wheeze, rattle/rattly chest, fever, runny/blocked nose, cough, or diarrhoea (with vomiting), by parent report
Measured: 0-12 months of age
Rate of any infection
Number of clinical episodes of where an infant had symptoms of: wheeze, rattle/rattly chest, fever, runny/blocked nose, cough, or diarrhoea (with vomiting), by parent report
Measured: Prior to first DTP vaccination
Rate of upper respiratory tract infection (URTI)
Number of clinical episodes of upper respiratory tract infections, by parent report
Measured: 0-12 months of age
Rate of upper respiratory tract infection (URTI)
Number of clinical episodes of upper respiratory tract infections, by parent report
Measured: Prior to first DTP vaccination
Rate of fever
Number of clinical episodes of fever, by parent report
Measured: 0-12 months of age
Rate of fever
Number of clinical episodes of fever, by parent report
Measured: Prior to first DTP vaccination
Diarrhoea
Proportion of participants with ≥1 episodes of diarrhoea
Measured: 0-12 months of age
Diarrhoea
Proportion of participants with ≥1 episodes of diarrhoea
Measured: Prior to first DTP vaccination
Rash with fever
Proportion of participants with ≥1 episodes of rash with fever
Measured: 0-12 months of age
Rash with fever
Proportion of participants with ≥1 episodes of rash with fever
Measured: Prior to first DTP vaccination
Eczema ever
Proportion of participants with eczema measured by a combined eczema measure
Measured: 0-12 months of age
Eczema ever
Proportion of participants with eczema measured by a combined eczema measure
Measured: 0-5 years of age
Eczema
Proportion of clinician-diagnosed eczema, by parental report
Measured: 0-12 months
Eczema
Proportion of clinician-diagnosed eczema, by parental report
Measured: 0-5 years of age
Eczema onset
Age of onset of eczema, by parental report
Measured: 0-12 months
Eczema onset
Age of onset of eczema, by parental report
Measured: 0-5 years of age
Eczema severity
Measured by parental report (POEM score)
Measured: 0-12 months
Eczema severity
Measured by clinical assessment (SCORAD)
Measured: 0-12 months
Eczema severity
Eczema medication use, by parental report
Measured: 0-12 months
Eczema severity
Measured by parental report (POEM score)
Measured: 0-5 years of age
Eczema severity
Measured by clinical assessment (SCORAD)
Measured: 0-5 years of age
Eczema severity
Eczema medication use, by parental report
Measured: 0-5 years of age
Asthma severity
Measured by asthma control test (ACT), by parental/participant report
Measured: 4 years of age
Asthma severity
Measured by asthma control test (ACT), by parental/participant report
Measured: 5 years of age
Asthma severity
Hospital admissions for asthma, by parental report
Measured: 2-5 years of age
Laboratory measures of the immune response
Measured: Time Frame: 0-5 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Feb 2025

First posted24 Jul 2013 (estimated)
Study startJul 2013
Primary completionSep 2023
Study completionFeb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for AllergyStudies of the same condition, open and under way.
More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01906853
Sponsor's protocol ID: BCG12/01
Other IDs: 1051228
Acronym: MIS BAIR
Status last verified: Feb 2025
First submitted: 21 Jul 2013
Last updated: 17 Feb 2025
Results posted: No
Data monitoring committee: No

Publications

Khazaei Y, Kodikara S, Butler CA, Messina NL, Le Cao KA, Dashper SG, Silva MJ. Development and validation of diagnostic and prognostic prediction tools for dental caries in young children through prospective and cross-sectional observational studies: a protocol. BMJ Open. 2025 Oct 5;15(10):e105145. doi: 10.1136/bmjopen-2025-105145.
PubMed 41047269
Pittet LF, Forbes EK, Donath S, Francis KL, Gardiner K, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, South M, Vuillermin P, Casalaz D, Curtis N, Messina NL; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG vaccination to prevent asthma: Results from the MIS BAIR randomized controlled trial. Pediatr Allergy Immunol. 2025 Jun;36(6):e70110. doi: 10.1111/pai.70110.
PubMed 40464744
Messina NL, Gardiner K, Pittet LF, Forbes EK, Francis KL, Freyne B, Zufferey C, Abruzzo V, Morison C, Turner H, Allen KJ, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, Vuillermin P, Donath S, Casalaz D, Curtis N; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial. Clin Exp Allergy. 2024 Sep;54(9):682-693. doi: 10.1111/cea.14537. Epub 2024 Jul 14.
PubMed 39004434
Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Morrison C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Donath S, Casalaz D, Phillips R, Curtis N. Discordance Between Diagnosis Tools for Assessing Eczema in Infants: A Challenge for Intervention Trials. Dermatitis. 2022 May-Jun 01;33(3):207-214. doi: 10.1097/DER.0000000000000842. Epub 2022 Feb 16.
PubMed 35170523
Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Francis KL, Morrison C, Zufferey C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Phillips R, Donath S, Casalaz D, Curtis N. Prevention of infant eczema by neonatal Bacillus Calmette-Guerin vaccination: The MIS BAIR randomized controlled trial. Allergy. 2022 Mar;77(3):956-965. doi: 10.1111/all.15022. Epub 2021 Aug 9.
PubMed 34309859
Cirovic B, de Bree LCJ, Groh L, Blok BA, Chan J, van der Velden WJFM, Bremmers MEJ, van Crevel R, Handler K, Picelli S, Schulte-Schrepping J, Klee K, Oosting M, Koeken VACM, van Ingen J, Li Y, Benn CS, Schultze JL, Joosten LAB, Curtis N, Netea MG, Schlitzer A. BCG Vaccination in Humans Elicits Trained Immunity via the Hematopoietic Progenitor Compartment. Cell Host Microbe. 2020 Aug 12;28(2):322-334.e5. doi: 10.1016/j.chom.2020.05.014. Epub 2020 Jun 15.
PubMed 32544459
Messina NL, Gardiner K, Donath S, Flanagan K, Ponsonby AL, Shann F, Robins-Browne R, Freyne B, Abruzzo V, Morison C, Cox L, Germano S, Zufferey C, Zimmermann P, Allen KJ, Vuillermin P, South M, Casalaz D, Curtis N. Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting. BMJ Open. 2019 Dec 15;9(12):e032844. doi: 10.1136/bmjopen-2019-032844.
PubMed 31843845
Zimmermann P, Perrett KP, van der Klis FR, Curtis N. The immunomodulatory effects of measles-mumps-rubella vaccination on persistence of heterologous vaccine responses. Immunol Cell Biol. 2019 Jul;97(6):577-585. doi: 10.1111/imcb.12246. Epub 2019 Mar 28.
PubMed 30791143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants
ClinicalTrials.gov ID: NCT01906853
Acronym / sponsor ID: MIS BAIR / BCG12/01
Conditions: Allergy, Eczema, Respiratory Tract Infections
Keywords: BCG, Bacille Calmette Guérin, Allergy, Immunity, Immune response, Vaccine, Infants, Children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,272 participants (actual)
Lead sponsor: Murdoch Childrens Research InstituteUniversity, hospital or other
Collaborators: Royal Children's Hospital, Mercy Hospital for Women, Australia, University of Melbourne
Study start: Jul 2013 (actual)
Primary completion: Sep 2023 (actual)
Study completion: Feb 2025 (actual)
First posted: 24 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life.
To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
No BCG	No intervention	–No BCG
BCG	Experimental	Biological: BCGMycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331

Who may qualify

Ages: Up to 10 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Less than 10 days old;
English speaking mother;
An informed consent form must be signed and dated by their parent(s) or legally acceptable representative after the nature of the study has been explained and prior to any study assessments/procedures;
The infant's mother has screened negative for HIV during this pregnancy;
Born no earlier than eight weeks before estimated date of delivery;

Key exclusion criteria (18 listed)

Any indication for BCG immunisation in the first 12 months of life including:
Known or suspected HIV infection
Treatment with corticosteroids or other immunosuppressive therapy, including monoclonal antibodies against tumour necrosis factor-alpha (TNF-alpha) (e.g. infliximab, etanercept, adalimumab).
Born to a mother treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies) in the 3rd trimester;
Congenital cellular immunodeficiencies including specific deficiencies of the interferon gamma pathway;

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
BCGAlso: BCG vaccine - Denmark strain, BCG Denmark, Statens Serum Institute BCG vaccine, Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331	Biological	BCG

Primary outcome

Atopic sensitisation measured by skin prick test (SPT)
Time frame: 1 year of age
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Atopic sensitisation measured by skin prick test (SPT)
Time frame: 5 years of age
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Lower respiratory tract infection (LRTI)
Time frame: 0-12 months
Measured by parent report
Lower respiratory tract infection (LRTI) hospital admissions
Time frame: 0-5 years of age
Proportion of participants with ≥1 hospital admission for LRTI reported by parent
Eczema ever
Time frame: 0-12 months
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Eczema ever
Time frame: 0-5 years of age
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Current asthma
Time frame: 5 years of age
Using ISAAC definitions
Asthma ever
Time frame: 5 years of age
Using ISAAC definitions

51 secondary outcomes

Clinical food allergy
Time frame: 1 year of age
Clinical food allergy
Time frame: 5 years of age
Atopic sensitisation measured by SPT using a more stringent cut-off
Time frame: 1 year of age
Atopic sensitisation measured by SPT using a more stringent cut-off
Time frame: 5 years of age
Atopic sensitisation to multiple allergens measured by SPT
Time frame: 1 year of age
Atopic sensitisation to multiple allergens measured by SPT
Time frame: 5 years of age
Parent report of food allergy
Time frame: 0-12 months of age
Parent report of food allergy
Time frame: 0-5 years of age
Egg sensitisation
Time frame: 1 year of age
Egg sensitisation
Time frame: 5 years of age
Egg allergy
Time frame: 1 year of age
Egg allergy
Time frame: 5 years of age
Atopic wheeze
Time frame: 1 year of age
Atopic wheeze
Time frame: 5 years of age
Lower respiratory tract infection (LRTI)
Time frame: Prior to first Diphtheria, Tetanus, Pertussis (DTP) vaccination
Lower respiratory tract infection (LRTI)
Time frame: 0-5 years of age
Rate of lower respiratory tract infection (LRTI)
Time frame: 0-12 months
Rate of lower respiratory tract infection (LRTI)
Time frame: Prior to first DTP vaccination
Rate of lower respiratory tract infection (LRTI)
Time frame: 0-5 years of age
Infections
Time frame: 0-12 months
Infections
Time frame: Prior to first DTP vaccination
Infections
Time frame: 0-5 years of age
Hospitalisation for respiratory tract infection (RTI)
Time frame: 0-12 months of age
Hospitalisation for respiratory tract infection (RTI)
Time frame: Prior to first DTP vaccination
Hospitalisation for respiratory tract infection (RTI)
Time frame: 0-5 years of age
Rate of any infection
Time frame: 0-12 months of age
Rate of any infection
Time frame: Prior to first DTP vaccination
Rate of upper respiratory tract infection (URTI)
Time frame: 0-12 months of age
Rate of upper respiratory tract infection (URTI)
Time frame: Prior to first DTP vaccination
Rate of fever
Time frame: 0-12 months of age
Rate of fever
Time frame: Prior to first DTP vaccination
Diarrhoea
Time frame: 0-12 months of age
Diarrhoea
Time frame: Prior to first DTP vaccination
Rash with fever
Time frame: 0-12 months of age
Rash with fever
Time frame: Prior to first DTP vaccination
Eczema ever
Time frame: 0-12 months of age
Eczema ever
Time frame: 0-5 years of age
Eczema
Time frame: 0-12 months
Eczema
Time frame: 0-5 years of age
Eczema onset
Time frame: 0-12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Derived from this study: PubMed 41047269Khazaei Y, Kodikara S, Butler CA, Messina NL, Le Cao KA, Dashper SG, Silva MJ. Development and validation of diagnostic and prognostic prediction tools for dental caries in young children through prospective and cross-sectional observational studies: a protocol. BMJ Open. 2025 Oct 5;15(10):e105145. doi: 10.1136/bmjopen-2025-105145.
Derived from this study: PubMed 40464744Pittet LF, Forbes EK, Donath S, Francis KL, Gardiner K, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, South M, Vuillermin P, Casalaz D, Curtis N, Messina NL; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG vaccination to prevent asthma: Results from the MIS BAIR randomized controlled trial. Pediatr Allergy Immunol. 2025 Jun;36(6):e70110. doi: 10.1111/pai.70110.
Derived from this study: PubMed 39004434Messina NL, Gardiner K, Pittet LF, Forbes EK, Francis KL, Freyne B, Zufferey C, Abruzzo V, Morison C, Turner H, Allen KJ, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, Vuillermin P, Donath S, Casalaz D, Curtis N; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial. Clin Exp Allergy. 2024 Sep;54(9):682-693. doi: 10.1111/cea.14537. Epub 2024 Jul 14.
Derived from this study: PubMed 35170523Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Morrison C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Donath S, Casalaz D, Phillips R, Curtis N. Discordance Between Diagnosis Tools for Assessing Eczema in Infants: A Challenge for Intervention Trials. Dermatitis. 2022 May-Jun 01;33(3):207-214. doi: 10.1097/DER.0000000000000842. Epub 2022 Feb 16.
Derived from this study: PubMed 34309859Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Francis KL, Morrison C, Zufferey C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Phillips R, Donath S, Casalaz D, Curtis N. Prevention of infant eczema by neonatal Bacillus Calmette-Guerin vaccination: The MIS BAIR randomized controlled trial. Allergy. 2022 Mar;77(3):956-965. doi: 10.1111/all.15022. Epub 2021 Aug 9.
Derived from this study: PubMed 32544459Cirovic B, de Bree LCJ, Groh L, Blok BA, Chan J, van der Velden WJFM, Bremmers MEJ, van Crevel R, Handler K, Picelli S, Schulte-Schrepping J, Klee K, Oosting M, Koeken VACM, van Ingen J, Li Y, Benn CS, Schultze JL, Joosten LAB, Curtis N, Netea MG, Schlitzer A. BCG Vaccination in Humans Elicits Trained Immunity via the Hematopoietic Progenitor Compartment. Cell Host Microbe. 2020 Aug 12;28(2):322-334.e5. doi: 10.1016/j.chom.2020.05.014. Epub 2020 Jun 15.
Derived from this study: PubMed 31843845Messina NL, Gardiner K, Donath S, Flanagan K, Ponsonby AL, Shann F, Robins-Browne R, Freyne B, Abruzzo V, Morison C, Cox L, Germano S, Zufferey C, Zimmermann P, Allen KJ, Vuillermin P, South M, Casalaz D, Curtis N. Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting. BMJ Open. 2019 Dec 15;9(12):e032844. doi: 10.1136/bmjopen-2019-032844.
Derived from this study: PubMed 30791143Zimmermann P, Perrett KP, van der Klis FR, Curtis N. The immunomodulatory effects of measles-mumps-rubella vaccination on persistence of heterologous vaccine responses. Immunol Cell Biol. 2019 Jul;97(6):577-585. doi: 10.1111/imcb.12246. Epub 2019 Mar 28.

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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.

Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD principal investigator

Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCG in people with Allergy and Eczema, run by Murdoch Childrens Research Institute at 2 sites in Australia.

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 7 inclusion and 18 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Atopic sensitisation measured by skin prick test (SPT) (time frame: 1 year of age). The study lists 8 primary outcomes in all. 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 NCT01906853, which also lists 8 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 17 Feb 2025.