Evidence map›Paper›PMID 26219694›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial.

Najaaraq Lund, Andreas Andersen, Anna Sofie K Hansen, Frida S Jepsen, Amarildo Barbosa, Sofie Biering-Sørensen, Amabelia Rodrigues, Henrik Ravn, Peter Aaby, Christine Stabell Benn

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. 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 92 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 4 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.

NCT00710983 naunknown statusnot on this map

Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

TypeinterventionalSponsorBandim Health ProjectRan2008 to 2015ConditionsInfant, Newborn, HealthyArmsOral polio vaccine
NCT03460002 phase4completednot on this mapstarted 2016, after this paper: background citation

A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children

TypeinterventionalSponsorBandim Health ProjectRan2016 to 2022Enrolled28,612ConditionsMeasles Vaccination, Oral Polio Vaccine, Non-specific/Heterologous Effects of Vaccines, MortalityArmsMeasles vaccine, Oral polio vaccine
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  12. Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
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  13. Nonspecific Effects of Oral Polio Vaccine on Diarrheal Burden and Etiology Among Bangladeshi Infants.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
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32 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Najaaraq LundResearch Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen Department of Pediatrics, Kolding Hospital/University of Southern Denmark, Kolding.
Andreas AndersenResearch Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen.
Anna Sofie K HansenBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Frida S JepsenBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Amarildo BarbosaBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Sofie Biering-SørensenBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Amabelia RodriguesBandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Henrik RavnResearch Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen Institute of Clinical Research, University of Southern Denmark/Odense University Hospital.
Peter AabyResearch Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
Christine Stabell BennResearch Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen Institute of Clinical Research, University of Southern Denmark/Odense University Hospital.

Funding

European Research Council 243149
6 · The paper itself

Abstract

backgroundRoutine vaccines may have nonspecific effects on mortality. An observational study found that OPV given at birth (OPV0) was associated with increased male infant mortality. We investigated the effect of OPV0 on infant mortality in a randomized trial in Guinea-Bissau.

methodsA total of 7012 healthy normal-birth-weight neonates were randomized to BCG only (intervention group) or OPV0 with BCG (usual practice). All children were to receive OPV with pentavalent vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B) at 6, 10, and 14 weeks of age. Seven national OPV campaigns were also conducted during the trial period. Children were followed to age 12 months. We used Cox regression to calculate hazard ratios (HRs) for mortality.

resultsThe trial contradicted the original hypothesis about OPV0 increasing male infant mortality. Within 12 months, 73 children in the BCG + OPV group and 87 children in the BCG-only group died, all from infectious diseases. Comparing BCG + OPV0 vs BCG only, the HR was 0.83 (95% confidence interval [CI], .61-1.13): 0.72 (95% CI, .47-1.10) in boys and 0.97 (95% CI, .61-1.54) in girls. For children enrolled within the first 2 days of life, the HR for BCG + OPV0 vs BCG only was 0.58 (95% CI, .38-.90). From enrollment until the time of OPV campaigns, the HR was 0.68 (95% CI, .45-1.00), the beneficial effect being separately significant for males (0.55 [95% CI, .32-.95]).

conclusionsThis is the only randomized trial of the effect of OPV0 on mortality. OPV0 may be associated with nonspecific protection against infectious disease mortality, particularly when given early in life. There are reasons to monitor mortality when OPV is being phased out. CLINICAL TRIALS REGISTRATION: NCT00710983.

Indexed as

Infant MortalityChild, PreschoolCommunicable DiseasesFemaleGuinea-BissauHumansInfantInfant, NewbornMalePoliovirus Vaccine, OralSurvival AnalysisPoliovirus Vaccine, Oralheterologous immunityinfant mortalityneonatesnonspecific effectsoral polio vaccine

Identifiers

PMID26219694
PMCPMC4614411

What OpenQuestion holds

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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.