Evidence map›Paper›PMID 42350005›Full record

ArticleBMJ open2026

Studying Early Life Live-Attenuated influenza virus immune Responses (STELLAR): study protocol for an exploratory observational study of the nasal mucosal and systemic immune response in healthy children given an intranasal live-attenuated influenza vaccine.

Karen Kelleher, Reuben Bennett, Rebecca Jackson, Lauri Ivaska, Nisha Singh, Reyna Sara Quintero Barceinas, Emma Plested, Emma Francis, Yama F Mujadidi, Chidimma Nwankwo and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Karen KelleherOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Reuben BennettOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0001-5248-8656
Rebecca JacksonOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0001-5217-2256
Lauri IvaskaOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Nisha SinghOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Reyna Sara Quintero BarceinasOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0005-6863-8144
Emma PlestedOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0001-9510-2880
Emma FrancisOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Yama F MujadidiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Chidimma NwankwoOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6575-4917
Jack Francis-HillOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Amber ThompsonOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Carla SolórzanoOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-9129-5569
Hannah BaughanOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Xinxue LiuOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-1107-0365
Arnaud M DidierlaurentCenter of Vaccinology, Department of Pathology and Immunology, University of Geneva, Geneva, GE, Switzerland.
Britta C UrbanOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-4197-8393
Daniela M FerreiraOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK daniela.ferreira@paediatrics.ox.ac.uk.
Dominic KellyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe mechanisms generating immunity involved in nasal vaccination for children are likely to differ significantly from both adult immunity and animal models. A deeper understanding is necessary for the development of future paediatric mucosal vaccines. Live-attenuated influenza vaccines (LAIVs) are licensed mucosal vaccines which confer protection in children against severe influenza. Beyond individual protection, mucosal vaccines can also limit transmission and colonisation, offering broader public health benefits than parenteral vaccination. We describe a protocol for an exploratory, observational study assessing systemic and mucosal responses to LAIV in healthy children. METHODS AND ANALYSIS: 40 healthy participants aged 2-5 years inclusively will be recruited from the community. Researchers will conduct study visits in the participants' homes and administer a single dose of their routine, yearly LAIV and collect blood, nasal cells, nasal fluid and saliva at baseline and at day 28 post-LAIV. They will have additional nasal fluid and saliva samples conducted by caregivers on days 1, 2, 3, 4, 6, 9, 14 and 21. They will complete a daily symptom report to detect symptoms due to vaccination as well as additional upper respiratory illnesses. Samples will be analysed to detect viral load for influenza virus strains included in LAIV, coinfection and colonisation by other pathogens, as well as assess the mucosal and systemic immune response to vaccination. This study aims to advance understanding of mucosal immunity mechanisms in children following live-attenuated influenza vaccination. This knowledge could help inform the development of future mucosal vaccines for children, potentially increasing both effectiveness, ease of delivery and tolerability in this vulnerable population. ETHICS AND DISSEMINATION: This protocol has been reviewed by the sponsor, collaborators and external peer reviewers. Ethical approval for this study has been obtained from the South Central - Hampshire B Research Ethics Committee (REC ref 24/SC/0251). Informed parental consent will be obtained prior to any study intervention. The results will be disseminated via publication in a peer-reviewed journal and presentation at international conferences. STUDY REGISTRATION: ISRCTN87260269 (https://doi.org/10.1186/ISRCTN87260269).

Indexed as

Immunity, MucosalInfluenza, HumanInfluenza VaccinesNasal MucosaAdministration, IntranasalChild, PreschoolFemaleHumansMaleObservational Studies as TopicResearch DesignSalivaVaccinationVaccines, AttenuatedInfluenza VaccinesVaccines, AttenuatedIMMUNOLOGYPaediatric infectious disease & immunisationVaccination

Identifiers

PMID42350005
PMCPMC13311587

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.