Evidence map›Paper›PMID 33681756›Full record

ArticleVaccine: X2021

Interchangeability, immunogenicity and safety of a combined 10-valent pneumococcal

Amanda Jane Leach, Edward Kim Mulholland, Mathuram Santosham, Paul John Torzillo, Peter McIntyre, Heidi Smith-Vaughan, Nicole Wilson, Beth Arrowsmith, Jemima Beissbarth, Mark D Chatfield and 8 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine: X, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% of its field
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
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

18 authors at 12 institutions in 4 countries.

Amanda Jane LeachChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Edward Kim MulhollandMurdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Australia.
Mathuram SantoshamJohns Hopkins Bloomberg School of Public Health, Baltimore, USA.
Paul John TorzilloPrince Alfred Hospital, Sydney, Australia.
Peter McIntyreNational Centre for Immunization Research and Surveillance, Sydney, Australia.
Heidi Smith-VaughanChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Nicole WilsonChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Beth ArrowsmithChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Jemima BeissbarthChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Mark D ChatfieldCentre for Health Services Research, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Victor M OguomaChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Paul LicciardiMurdoch Children's Research Institute, Dept of Paediatrics, University of Melbourne, Melbourne, Australia.
Sue SkullDept of Child Health Research, Perth Children's Hospital, University of Western Australia, Perth, Australia.
Ross AndrewsChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Jonathan CarapetisTelethon Kids Institute, University of Western Australia, Australia.
Joseph McDonnellConsultant Statistician, 3291TR Strijen, Netherlands.
Vicki KrauseCentre for Disease Control, Northern Territory Department of Health, Darwin, Australia.
Peter Stanley MorrisChild Health Division, Menzies School of Heath Research, PO Box 41096, Casuarina, Australia.
Charles Darwin University · AUThe University of Melbourne · AUAustralian National University · AUCentraal Bureau voor de Statistiek · NLGovernment of Western Australia Department of Health · AUJohns Hopkins University · USNational Centre for Immunisation Research & Surveillance · AUThe Kids Research Institute Australia · AUThe University of Queensland · AUThe University of Sydney · AUThe University of Western Australia · AUUniversity of Canberra · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAboriginal children living in remote communities are at high risk of early and persistent otitis media.

methodsThis open-label superiority trial randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to PCV13 (P) at 2-4-6 months (_PPP), PHiD-CV10 (S) at 2-4-6 months (_SSS), or PHiD-CV10 at 1-2-4 plus PCV13 at -6 months (SSSP). Primary outcomes (blinded) were immunogenicity against PCV13-only serotypes 3, 6A, 19A, and PHiD-CV10-only protein D at 7 months. Secondary outcomes include immunogenicity against all serotypes at 2, 4 and 7 months.

findingsBetween 2011 and 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(1 4 1). An intention to treat approach including all available data was used. The SSSP group had superior immunogenicity against serotypes 3, 6A, and 19A compared to _SSS (OPA GMT ratios 8.1 to 59.5, p < 0.001), and against protein D compared to _PPP (GMC ratio 11.9 (95%CI 9.7 to 14.6)). Immune responses to protein D and 3, 6A, and 19A in SSSP were not significantly lower (i.e. no harm) than either _SSS or _PPP. For ten common serotypes responses at 2, 4 and 7 months were superior for SSSP (following 1-, 2-, and 4- doses) than _SSS and _PPP (following 0-, 1-, and 3- doses). At 4 months, _SSS was superior to _PPP. Reactogenicity and hospitalisations were rare and unrelated to the intervention.

interpretationFrom two months, the 1-2-4-6-month combined schedule (SSSP) was safe and significantly more immunogenic than 2-4-6-month schedules. The earlier responses may be beneficial in high-risk populations.

Indexed as

Aboriginal and Torres Strait IslanderMixed schedule primary course vaccinationNon-typeable Haemophilus influenzae protein DPneumococcal conjugate vaccinesRandomised controlled trial

Identifiers

PMID33681756
PMCPMC7930582
OpenAlexW3130318964

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.