Evidence map›Paper›PMID 34140345›Full record

ArticleBMJ open2021

A pragmatic health centre-based evaluation comparing the effectiveness of a PCV13 schedule change from 3+0 to 2+1 in a high pneumococcal carriage and disease burden setting in Malawi: a study protocol.

Todd D Swarthout, Ana Ibarz-Pavon, Gift Kawalazira, George Sinjani, James Chirombo, Andrea Gori, Peter Chalusa, Farouck Bonomali, Roseline Nyirenda, Edwin Bulla and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04078997 (Pneumococcal Conjugate Vaccine 13), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT04078997 completednot on this map

Pneumococcal Conjugate Vaccine 13 (PCV13) Schedule Change From 3+0 to 2+1 to Accelerate Reduction in Pneumococcal Vaccine Serotype Carriage in Blantyre, Malawi: an Effectiveness Study

TypeobservationalSponsorUniversity of LiverpoolRan2019 to 2024Enrolled3,507Conditions13-valent Pneumococcal Vaccine, Streptococcus PneumoniaeArmsnasopharyngeal swab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Todd D SwarthoutNIHR Global Health Research Unit on Mucosal Pathogens, Division of Infection and Immunity, University College London, London, UK t.swarthout@ucl.ac.uk.ORCID 0000-0001-5285-7039
Ana Ibarz-PavonMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Gift KawalaziraMinistry of Health, Lilongwe, Malawi.
George SinjaniMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
James ChiromboMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Andrea GoriNIHR Global Health Research Unit on Mucosal Pathogens, Division of Infection and Immunity, University College London, London, UK.
Peter ChalusaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Farouck BonomaliMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Roseline NyirendaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Edwin BullaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Comfort BrownMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Jacquline MsefulaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Marjory BandaMinistry of Education, Blantyre, Malawi.
Jean KachalaMinistry of Health, Lilongwe, Malawi.
Charles MwansamboMinistry of Health, Lilongwe, Malawi.
Marc Yr HenrionMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Stephen B GordonMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Neil FrenchMalawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Robert S HeydermanNIHR Global Health Research Unit on Mucosal Pathogens, Division of Infection and Immunity, University College London, London, UK.ORCID 0000-0003-4573-449X

Funding

Medical Research Council MR/N023129/1Wellcome TrustWellcome Trust 206545/Z/17/Z
6 · The paper itself

Abstract

introduction

methodsA pragmatic health centre-based evaluation comparing impact of a PCV13 schedule change from 3+0 to 2+1 in Blantyre district, Malawi. Twenty government health centres will be randomly selected, with ten implementing a 2+1 and 10 to continue with the 3+0 schedule. Health centres implementing 3+0 will serve as the direct comparator in evaluating 2+1 providing superior direct and indirect protection against pneumococcal carriage. Pneumococcal carriage surveys will evaluate carriage prevalence among children 15-24 months, randomised at household level, and schoolgoers 5-10 years of age, randomly selected from school registers. Carriage surveys will be conducted 18 and 33 months following 2+1 implementation. ANALYSIS: The primary endpoint is powered to detect an effect size of 50% reduction in vaccine serotype (VT) carriage among vaccinated children 15-24 months old, expecting a 14% and 7% VT carriage prevalence in the 3+0 and 2+1 arms, respectively. ETHICS AND DISSEMINATION: The study has been approved by the Malawi College of Medicine Research Ethics Committee (COMREC; Ref: P05.19.2680), the University College London Research Ethics Committee (Ref: 8603.002) and the University of Liverpool Research Ethics Committee (Ref: 5439). The results from this study will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04078997.

Indexed as

Pneumococcal InfectionsStreptococcus pneumoniaeCarrier StateChildChild, PreschoolCost of IllnessHumansInfantLondonMalawiNasopharynxPneumococcal VaccinesPragmatic Clinical Trials as TopicSouth AfricaVaccines, ConjugatePneumococcal VaccinesVaccines, Conjugateepidemiologypaediatric infectious disease & immunisationpublic health

Identifiers

PMID34140345
PMCPMC8212416

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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.