Evidence map›Paper›PMID 31843845›Full record

ArticleBMJ open2019

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.

Nicole L Messina, Kaya Gardiner, Susan Donath, Katie Flanagan, Anne-Louise Ponsonby, Frank Shann, Roy Robins-Browne, Bridget Freyne, Veronica Abruzzo, Clare Morison and 9 more

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01906853 phase3completednot on this map

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

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2013 to 2025Enrolled1,272ConditionsAllergy, Eczema, Respiratory Tract InfectionsArmsBCG
NCT05168709 phase4completednot on this mapstarted 2022, after this paper: background citation

A Single-arm Clinical Trial to Investigate COVID-19 Specific Vaccine and Heterologous Immunity in the Melbourne Infant Study of BCG for Allergy and Infection Reduction (COSI BAIR)

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2022 to 2022Enrolled51ConditionsCOVID-19, Vaccine Reaction, Immunization, InfectionArmsTozinameran
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Changes in Atopic Sensitisation From 1 to 5 Years of Age: Longitudinal Data From the MIS BAIR Trial.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
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  14. Article
  15. Review
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  17. Article
  18. A pragmatic approach to infant feeding for food allergy prevention.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2022
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Nicole L MessinaInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-8404-4462
Kaya GardinerInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-9796-4567
Susan DonathDepartment of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
Katie FlanaganSchool of Health Sciences, University of Tasmania, Hobart, Tasmania, Australia.
Anne-Louise PonsonbyDepartment of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
Frank ShannDepartment of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
Roy Robins-BrowneInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Bridget FreyneInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Veronica AbruzzoInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Clare MorisonInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Lianne CoxInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Susie GermanoInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Christel ZuffereyInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Petra ZimmermannInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Katie J AllenFormerly of Centre for Food and Allergy Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Peter VuillerminSchool of Medicine, Deakin University, Geelong, Victoria, Australia.
Mike SouthDepartment of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
Dan CasalazNeonatal Intensive Care Unit, Mercy Hospital for Women, Heidelberg, Victoria, Australia.
Nigel CurtisInfectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia nigel.curtis@rch.org.au.ORCID 0000-0003-3446-4594

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBCG vaccination reduces all-cause infant mortality in high-mortality settings by more than can be attributed to protection against tuberculosis. This is proposed to result from non-specific protection against non-vaccine targeted ('off-target') infections. There is also evidence that BCG protects against allergic diseases. METHODS AND ANALYSIS: The Melbourne Infant Study: BCG for Allergy and Infection Reduction is a phase III multicentre, single-blinded, randomised controlled trial. A total of 1438 healthy neonates will be randomised to receive either BCG vaccination or no BCG vaccination in the first 10 days of life. Measures of allergy, eczema, infection and asthma will be obtained from parent-completed questionnaires 3 monthly in the first year and 6 monthly from 1 to 5 years of age, and clinical assessments at 1 and 5 years of age. Biological samples will also be collected for future immunological studies. ANALYSIS PRIMARY OUTCOME: The proportion of participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5 years of age, and asthma at 5 years of age. SECONDARY OUTCOMES: (1) the proportion of participants with additional measures of allergy, eczema, asthma and infections; (2) medication use for eczema and asthma; (3) the severity and age of onset of eczema and asthma; (4) the number of episodes of infection; (5) hospitalisations for infections and (6) laboratory measures of immune responses. ETHICS AND DISSEMINATION: This trial has ethical and governance approval from Mercy Health Human Research Ethics Committee (HREC, No. R12-28) and Royal Children's Hospital HREC (No. 33025) with additional governance approval from Barwon Health and St John of God, Geelong, Victoria. Results of this trial will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NCT01906853.

Indexed as

VaccinationAllergensAsthmaBCG VaccineChild, PreschoolClinical Trials, Phase III as TopicHumansInfantInfant, NewbornMulticenter Studies as TopicRandomized Controlled Trials as TopicSingle-Blind MethodAllergensBCG Vaccineallergyasthmaeczemaimmunologyimmunsationinfectious diseasespaediatric

Identifiers

PMID31843845
PMCPMC6924750

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.