Evidence map›Paper›PMID 38977298›Full record

Trial reportArchives of disease in childhood2024

An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants.

Anna Calvert, Nick Andrews, Sheula Barlow, Ray Borrow, Charlotte Black, Barbara Bromage, Jeremy Carr, Paul Clarke, Andrew C Collinson, Karen Few and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of disease in childhood, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03125616 (Babies Born Early Antibody Response to Men B Vaccination), 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.

NCT03125616 phase4completednot on this map

Babies Born Early Antibody Response to Men B Vaccination: A Phase IV Multicentre Randomised Study to Evaluate the Primary and Booster Immune Responses in UK Preterm Infants Receiving Routine Immunisations and Incorporating a Three Dose Versus a Two Dose Schedule of 4CMenB (Bexsero®) for Primary Immunisation.

TypeinterventionalSponsorSt George's, University of LondonRan2017 to 2020Enrolled136ConditionsPrematurity, Vaccination, Meningococcal DiseaseArms4CMenB Vaccine
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

20 authors.

Anna CalvertCentre for Neonatal and Paediatric Infection and Vaccine Institute, St George's, University of London, London, UK acalvert@sgul.ac.uk.ORCID 0000-0002-1922-6208
Nick AndrewsImmunisation and Vaccine Preventable Diseases Division, UK Health Security Agency, London, UK.
Sheula BarlowOxford University Hospitals NHS Foundation Trust, Oxford, UK.
Ray BorrowVaccine Evaluation Unit, UK Health Security Agency, Manchester Royal Infirmary, Manchester, UK.
Charlotte BlackOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Barbara BromageRoyal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK.
Jeremy CarrOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Paul ClarkeNeonatal Intensive Care Unit, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.ORCID 0000-0001-6203-7632
Andrew C CollinsonRoyal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK.
Karen FewNeonatal Intensive Care Unit, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.
Naomi HaywardCentre for Neonatal and Paediatric Infection and Vaccine Institute, St George's, University of London, London, UK.
Christine E JonesFaculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.ORCID 0000-0003-1523-2368
Kirsty Le DoareCentre for Neonatal and Paediatric Infection and Vaccine Institute, St George's, University of London, London, UK.
Shamez N LadhaniCentre for Neonatal and Paediatric Infection and Vaccine Institute, St George's, University of London, London, UK.ORCID 0000-0002-0856-2476
Jennifer LouthVaccine Evaluation Unit, UK Health Security Agency, Manchester Royal Infirmary, Manchester, UK.
Georgia PapadopoulouOxford University Hospitals NHS Foundation Trust, Oxford, UK.
Michelle PoplePortsmouth Hospitals University NHS Trust, Portsmouth, UK.
Tim ScorrerPortsmouth Hospitals University NHS Trust, Portsmouth, UK.
Matthew D SnapeOxford University Hospitals NHS Foundation Trust, Oxford, UK.
Paul T HeathCentre for Neonatal and Paediatric Infection and Vaccine Institute, St George's, University of London, London, UK.ORCID 0000-0002-7540-7433

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.

designAn open-label, phase IV randomised study conducted across six UK sites.

settingNeonatal units, postnatal wards, community recruitment following discharge.

participants129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).

interventionsInfants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.

main outcome measuresSerum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.

resultsThere were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).

conclusionsBoth schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference. TRIAL REGISTRATION NUMBER: NCT03125616.

Indexed as

Immunization ScheduleInfant, PrematureMeningococcal VaccinesAntibodies, BacterialFemaleHumansInfantInfant, NewbornMaleMeningococcal InfectionsNeisseria meningitidis, Serogroup BUnited Kingdom4CMenB vaccineAntibodies, BacterialMeningococcal Vaccinesinfectious disease medicinepaediatrics

Identifiers

PMID38977298
PMCPMC11503106

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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.