Trial reportPediatric research2016
Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial.
Trial report in Pediatric research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04534803 (Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review of BCG vaccination policies among high-risk groups in low TB-burden countries: implications for vaccination strategy in Canadian indigenous communities.BMC public health · 2019Pooled it
- Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).BMJ (Clinical research ed.) · 2025Trial
- Impact of vaccine platform and BCG vaccination on antibody responses to COVID-19 vaccination.Frontiers in immunology · 2023Trial
- Neonatal BCG Vaccination Reduces Interferon-γ Responsiveness to Heterologous Pathogens in Infants From a Randomized Controlled Trial.The Journal of infectious diseases · 2020Trial
- Bacillus Calmette-Guérin vaccination at birth and in vitro cytokine responses to non-specific stimulation. A randomized clinical trial.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Trial
- Effects of Bacillus Calmette-Guérin (BCG) vaccination at birth on T and B lymphocyte subsets: Results from a clinical randomized trial.Scientific reports · 2017Trial
- Bacillus Calmette-Guérin vaccination, thymic size, and thymic output in healthy newborns.Pediatric research · 2017Trial
- The mark of success: The role of vaccine-induced skin scar formation for BCG and smallpox vaccine-associated clinical benefits.Seminars in immunopathology · 2024Review
- Interpreting the Results of Trials of BCG Vaccination for Protection Against COVID-19.The Journal of infectious diseases · 2023Review
- Non-Specific Effects of Bacillus Calmette-Guérin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Vaccines · 2023Review
- Article
- Review
- Bacille Calmette-Guérin vaccine reprograms human neonatal lipid metabolism in vivo and in vitro.Cell reports · 2022Article
- Can what have we learnt about BCG vaccination in the last 20 years help us to design a better tuberculosis vaccine?Vaccine · 2022Review
- Bacillus Calmette-Guerin 's beneficial impact on glucose metabolism: evidence for broad based applications.iScience · 2021Article
- COVID-19 and Beyond: Exploring Public Health Benefits from Non-Specific Effects of BCG Vaccination.Microorganisms · 2021Review
- BCG turns 100: its nontraditional uses against viruses, cancer, and immunologic diseases.The Journal of clinical investigation · 2021Review
- Article
- The BCG Vaccine for COVID-19: First Verdict and Future Directions.Frontiers in immunology · 2021Review
- Bacille Calmette Guérin (BCG) and new TB vaccines: Specific, cross-mycobacterial and off-target effects.Paediatric respiratory reviews · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChildhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects.
methodsA randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.
resultsThe analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).
conclusionThis study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.
Indexed as
Identifiers
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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.