Trial reportBMJ global health2024
Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau.
Trial report in BMJ global health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02504203 (Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial), which is not on this map. Cited by 4 papers.
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.
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
Who cites it
4 citing papers in PubMed, 11 citations in OpenAlex.
- 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
- The origin of non-specific effects of vaccines and the role of randomised clinical trials.Human vaccines & immunotherapeutics · 2026Review
- The BCGMethodsX · 2025Article
- The mark of success: The role of vaccine-induced skin scar formation for BCG and smallpox vaccine-associated clinical benefits.Seminars in immunopathology · 2024Review
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 at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery.
designCluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms.
settingBandim Health Project Health and Demographic Surveillance System, Guinea-Bissau.
participants2226 newborns enrolled between July 2016 and August 2019.
interventionsIn both arms, newborns received a home visit within 72 hours after birth. In intervention clusters (n=46), BCG and OPV were provided at the home visit.
main outcome measureRates of non-accidental mortality were compared in Cox proportional hazards models from (last of) day 1 or enrolment, until (first of) day 60 or registration of non-trial vaccines.
resultsA total of 35 deaths (intervention: 7, control: 28) were registered during the trial. Providing BCG and OPV reduced non-accidental early infant mortality by 59% (8-82%). The intervention also reduced non-accidental hospital admissions. The intervention had little impact on growth and BCG scarring and tended to increase the risk of consultations.
conclusionsThe trial was stopped early due to lower-than-expected enrolment and event rates when 33% of the planned number of newborns had been enrolled. Despite the small size of the trial, the results support that early BCG and OPV vaccinations are beneficial and reduce early child mortality and morbidity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02504203).
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