Evidence map›Paper›PMID 42772879›Full record

ArticleBMJ open2026

Open-label, randomised controlled, multicentre study evaluating higher valency pneumococcal vaccines (PCV15/PCV20) compared with PCV13 given in homologous schedules at 3 months and 12 months ('1+1' schedule) and 2 months, 4 months and 12 months ('2+1' schedule) in infants: protocol.

Riffat Aslam, Oluwasefunmi Akeju, Elizabeth Clutterbuck, Charlie Appleby, Denis Murphy, Alix De Calignon, Jilly Muller, Rachel White, Ankana Singha, Yama F Mujadidi and 10 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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

20 authors.

Riffat AslamDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK riffat.aslam@paediatrics.ox.ac.uk.ORCID http://orcid.org/0009-0007-1601-0608
Oluwasefunmi AkejuDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Elizabeth ClutterbuckDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Charlie ApplebyDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Denis MurphyDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Alix De CalignonDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Jilly MullerDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Rachel WhiteDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Ankana SinghaDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Yama F MujadidiDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Marion RoderickBristol Vaccine Centre, L6 Education & Research Centre, Bristol, UK.
David P J TurnerCripps Health Centre, The University of Nottingham Health Service, Nottingham, UK.
Paul T HeathVaccine Institute & Centre for Neonatal and Paediatric Infection, City St. George's, University, London, UK.ORCID http://orcid.org/0000-0002-7540-7433
Daniel OwensNIHR Southampton Clinical Research Facility, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
David GoldblattGreat Ormond Street Institute of Child Health, University College London, London, UK.
Narges EbrahimiDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.
Xinxue LiuDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.ORCID http://orcid.org/0000-0003-1107-0365
Saul FaustNIHR Southampton Clinical Research Facility, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Maheshi Nirmala N RamasamyDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.ORCID http://orcid.org/0000-0002-2119-951X
Dominic KellyDepartment of Paediatrics, Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine (CCVTM), University of Oxford, Oxford, England, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost recent childhood invasive pneumococcal disease in the UK is caused by serotypes not included in the currently used pneumococcal conjugate vaccine (PCV13). There is potential for additional protection with newer PCVs that have wider serotype coverage but there are no data on these vaccines being given in the 1+1 schedule used in the UK. This study will determine whether the PCV13 serotype-specific antibody responses to PCV15 and PCV20 given at 3 and 12 months (1+1 schedule) are non-inferior to PCV13 serotype-specific antibody responses to PCV13 given in the same schedule. It will also determine whether PCV13 serotype-specific antibody responses to PCV20 given at 2, 4 and 12 months (2+1 schedule) are non-inferior to PCV13 serotype-specific antibody response to PCV13 given at 3 and 12 months (1+1 schedule).

methodsThis will be an open-label, randomised controlled multicentre study in 600 infants. Healthy infants will be enrolled at 8 weeks and randomised 1:1:1:1 to receive 2 doses (1+1) of either PCV15, PCV20 or PCV13 at 3 and 12 months of age or 3 doses (2+1) of PCV20 at 2, 4 and 12 months. Blood and nasal samples will be collected at specified intervals to assess serum and nasal IgG levels and carriage. Postprimary and postbooster IgG levels in the PCV15 and PCV20 arms will be compared against PCV13. ETHICS AND DISSEMINATION: Ethical approval for this study has been obtained from the South Central-Hampshire A Research Ethics Committee (REC ref 24/SC/0222). The results will be disseminated via publication in a peer-reviewed journal and presentations at international conferences. TRIAL REGISTRATION NUMBER: ISRCTN17673117.

Indexed as

Immunization SchedulePneumococcal InfectionsPneumococcal VaccinesStreptococcus pneumoniaeAntibodies, BacterialHumansInfantMulticenter Studies as TopicRandomized Controlled Trials as TopicUnited Kingdom13-valent pneumococcal vaccineAntibodies, BacterialPneumococcal VaccinesChildCommunity child healthImmunization ProgramsPaediatric infectious disease & immunisationVaccination

Identifiers

PMID42772879
PMCPMC13599847

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.