Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017
Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 156 papers, 2 of them syntheses that pooled 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.
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.
Sex-Differential Health Interventions In Low-Birth-Weight Infants
Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Effects on Early-life Mortality and Morbidity
BCG Vaccine to Reduce Unplanned Absenteeism Due to Illness of Health Care Workers During the COVID-19 Pandemic. A Multi-center Randomised Controlled Trial (BCG-COVID-RCT)
Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality? A Cluster Randomised Trial
The Role of the Bacillus Calmette-Guérin Vaccine (BCG) in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Vaccines
BCG2-DTP3: Providing BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine to Improve Female Survival in Africa
Using AS01 Adjuvant to Improve Immune Response in Older Adults Through Trained Immunity
Who cites it
156 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evidence-based interventions to reduce mortality among preterm and low-birthweight neonates in low-income and middle-income countries: a systematic review and meta-analysis.BMJ global health · 2021Pooled it
- Safety and Immunogenicity of Early Bacillus Calmette-Guérin Vaccination in Infants Who Are Preterm and/or Have Low Birth Weights: A Systematic Review and Meta-analysis.JAMA pediatrics · 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
- BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.The Journal of infection · 2024Trial
- Effects of Neonatal BCG-Japan Versus BCG-Russia Vaccination on Overall Mortality and Morbidity: Randomized Controlled Trial From Guinea-Bissau (BCGSTRAIN II).Open forum infectious diseases · 2024Trial
- Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau.BMJ global health · 2024Trial
- Safety of BCG vaccination and revaccination in healthcare workers.Human vaccines & immunotherapeutics · 2023Trial
- Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.Cell reports. Medicine · 2022Trial
- Non-specific effects of BCG and DTP vaccination on infant mortality: An analysis of birth cohorts in Ghana and Tanzania.Vaccine · 2022Trial
- Efficacy and Safety of BCG Revaccination WithFrontiers in immunology · 2022Trial
- Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence.Frontiers in immunology · 2022Trial
- BCG-induced non-specific effects on heterologous infectious disease in Ugandan neonates: an investigator-blind randomised controlled trial.The Lancet. Infectious diseases · 2021Trial
- Neonatal BCG vaccination and child survival in TB-exposed and TB-unexposed children: a prospective cohort study.BMJ open · 2020Trial
- Seasonal variation in the non-specific effects of BCG vaccination on neonatal mortality: three randomised controlled trials in Guinea-Bissau.BMJ global health · 2020Trial
- Outcomes of controlled human malaria infection after BCG vaccination.Nature communications · 2019Trial
- BCG vaccination in Korea, Japan, and Taiwan: Current status and future perspectives.Human vaccines & immunotherapeutics · 2026Review
- The origin of non-specific effects of vaccines and the role of randomised clinical trials.Human vaccines & immunotherapeutics · 2026Review
- γδ T Cells at the Crossroads of Tuberculosis and COPD: From Early Immunity to Tissue Remodeling.International journal of molecular sciences · 2026Review
- BCG-induced trained immunity on clinical outcomes in moderate to severe COVID-19 patients at a tertiary care center: A comparative study based on interferon-gamma release assays status.Journal of family medicine and primary care · 2026Article
- BCG immunisation through intranasal instillation protects mice against Streptococcus pneumoniae infection by enhancing alveolar macrophage activity.Scientific reports · 2026Article
96 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: BCG vaccine may reduce overall mortality by increasing resistance to nontuberculosis infections. In 2 randomized trials in Guinea-Bissau of early BCG-Denmark (Statens Serum Institut) given to low-weight (LW) neonates (<2500 g at inclusion) to reduce infant mortality rates, we observed a very beneficial effect in the neonatal period. We therefore conducted the present trial to test whether early BCG-Denmark reduces neonatal mortality by 45%. We also conducted a meta-analysis of the 3 BCG-Denmark trials. Methods: In 2008-2013, we randomized LW neonates to "early BCG-Denmark" (intervention group; n = 2083) or "control" (local policy for LW and no BCG-Denmark; n = 2089) at discharge from the maternity ward or at first contact with the health center. The infants were randomized (1:1) without blinding in blocks of 24. Data was analyzed in Cox hazards models providing mortality rate ratios (MRRs). We had prespecified an analysis censoring follow-up at oral poliovirus vaccine campaigns. Results: Early administration of BCG-Denmark was associated with a nonsignificant reduction in neonatal mortality rate (MRR, 0.70; 95% confidence interval [CI], .47-1.04) and a 34% reduction (0.66; .44-1.00) when censoring for oral poliovirus vaccine campaigns. There was no reduction in mortality rate for noninfectious diseases, but a 43% reduction in infectious disease mortality rate (MRR, 0.57; 95% CI, .35-.93). A meta-analysis of 3 BCG trials showed that early BCG-Denmark reduced mortality by 38% (MRR, 0.62; 95% CI, .46-.83) within the neonatal period and 16% (0.84; .71-1.00) by age 12 months. Conclusion: Early administration of BCG-Denmark in LW infants is associated with major reductions in mortality rate. It is important that all LW infants receive early BCG in areas with high neonatal mortality rates. Clinical Trials Registration: NCT00625482.
Indexed as
Identifiers
What OpenQuestion holds
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.