Evidence map›Paper›PMID 34146093›Full record

Trial reportThe Journal of infectious diseases2021

Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial.

Nicole L Messina, Laure F Pittet, Kaya Gardiner, Bridget Freyne, Kate L Francis, Christel Zufferey, Veronica Abruzzo, Clare Morrison, Katrina J Allen, Katie L Flanagan and 8 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05168709 (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), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
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.

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

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. 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
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 5 countries.

Nicole L MessinaInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-8404-4462
Laure F PittetInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Kaya GardinerInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Bridget FreyneInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-9542-1582
Kate L FrancisInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Christel ZuffereyInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Veronica AbruzzoInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Clare MorrisonInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Katrina J AllenFormerly of Centre for Food and Allergy Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Katie L FlanaganSchool of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.
Anne-Louise PonsonbyInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Roy Robins-BrowneInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Frank ShannDepartments of Paediatrics; Microbiology and Immunology, The University of Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-9899-1804
Mike SouthInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Peter VuillerminInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Susan DonathInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Dan CasalazNeonatal Intensive Care Unit, Mercy Hospital for Women, Heidelberg, Victoria, Australia.
Nigel CurtisInfectious Diseases; Clinical Epidemiology and Biostatistics Unit; Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
The University of Melbourne · AUOffice of Infectious Diseases · USRoyal Children's Hospital · AUBarwon Health · AUMercy Hospital for Women · AUMurdoch Children's Research Institute · AUUniversity of Liverpool · GBUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacille Calmette-Guérin (BCG) vaccination has beneficial off-target effects that may include protecting against non-mycobacterial infectious diseases. We aimed to determine whether neonatal BCG vaccination reduces lower respiratory tract infections (LRTI) in infants in the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) trial.

methodsIn this investigator-blinded trial, neonates in Australia were randomized to receive BCG-Denmark vaccination or no BCG at birth. Episodes of LRTI were determined by symptoms reported in parent-completed, 3-month questionnaires over the first year of life. Data were analyzed by intention-to-treat using binary regression.

resultsA total of 1272 neonates were randomized to the BCG vaccination (n = 637) or control (n = 635) group. The proportion of participants with an episode of LRTI in the first year of life among BCG-vaccinated infants was 54.8% compared to 58.0% in the control group, resulting in a risk difference of -3.2 (95% confidence interval, -9.0 to 2.6) after multiple imputation. There was no interaction observed between the primary outcome and sex, maternal BCG, or the other prespecified effect modifiers.

conclusionsBased on the findings of this trial, there is insufficient evidence to support the use of neonatal BCG vaccination to prevent LRTI in the first year of life in high-income settings.

Indexed as

AustraliaBCG VaccineFemaleFeverHumansInfantInfant, NewbornInfectionsMalePregnancyRespiratory Tract InfectionsVaccinationBCG VaccineBCGinfantinfectionnonspecificoff-target

Identifiers

PMID34146093
OpenAlexW3170281874

What OpenQuestion holds

Textmetadata
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.