Evidence map›Paper›PMID 38829821›Full record

Trial reportPLoS medicine2024

Hearing loss in Australian First Nations children at 6-monthly assessments from age 12 to 36 months: Secondary outcomes from randomised controlled trials of novel pneumococcal conjugate vaccine schedules.

Amanda Jane Leach, Nicole Wilson, Beth Arrowsmith, Jemima Beissbarth, Kim Mulholland, Mathuram Santosham, Paul John Torzillo, Peter McIntyre, Heidi Smith-Vaughan, Sue A Skull and 12 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are 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.

NCT01174849 phase4completednot on this map

A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes

TypeinterventionalSponsorMenzies School of Health ResearchRan2011 to 2018Enrolled425ConditionsOtitis MediaArmsSynflorix, Prevenar13, COMBO
NCT01735084 phase4completednot on this map

Pneumococcal Conjugate Vaccine (PCV) Schedules for the Northern Territory (NT): Randomised Controlled Trial of Booster Vaccines to Broaden and Strengthen Protection From Invasive and Mucosal Infections.

TypeinterventionalSponsorMenzies School of Health ResearchRan2013 to 2019Enrolled261ConditionsOtitis Media, Febrile Illness, Cough, Lower Respiratory Tract InfectionArmsPrevenar13, Synflorix
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

22 authors.

Amanda Jane LeachMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.ORCID 0000-0002-4638-8392
Nicole WilsonMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Beth ArrowsmithMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.ORCID 0000-0001-9841-2692
Jemima BeissbarthMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Kim MulhollandLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Mathuram SantoshamDepartments of International Health and Pediatrics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Paul John TorzilloRoyal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
Peter McIntyreDiscipline of Child and Adolescent Health, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-5808-7450
Heidi Smith-VaughanMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Sue A SkullDivision of Paediatrics and Child Health, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0001-7677-510X
Victor M OguomaMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.ORCID 0000-0001-9505-7197
Mark D ChatfieldMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.ORCID 0000-0002-0004-6274
Deborah LehmannTelethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0002-1734-5414
Christopher G Brennan-JonesTelethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0001-7216-8097
Michael J BinksMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Paul V LicciardiLondon School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID 0000-0001-6086-6285
Ross M AndrewsOffice of the Chief Health Officer, Queensland Health, Brisbane, Queensland, Australia.
Tom SnellingSchool of Public Health, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-4670-0638
Vicki KrauseCentre for Disease Control (CDC)-Environmental Health, Northern Territory Health, Darwin, Northern Territory, Australia.
Jonathan CarapetisTelethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0002-1182-9792
Anne B ChangMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.ORCID 0000-0002-1331-3706
Peter Stanley MorrisMenzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Australian remote communities, First Nations children with otitis media (OM)-related hearing loss are disproportionately at risk of developmental delay and poor school performance, compared to those with normal hearing. Our objective was to compare OM-related hearing loss in children randomised to one of 2 pneumococcal conjugate vaccine (PCV) formulations. METHODS AND

findingsIn 2 sequential parallel, open-label, randomised controlled trials (the PREVIX trials), eligible infants were first allocated 1:1:1 at age 28 to 38 days to standard or mixed PCV schedules, then at age 12 months to PCV13 (13-valent pneumococcal conjugate vaccine, +P) or PHiD-CV10 (10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine, +S) (1:1). Here, we report prevalence and level of hearing loss outcomes in the +P and +S groups at 6-monthly scheduled assessments from age 12 to 36 months. From March 2013 to September 2018, 261 infants were enrolled and 461 hearing assessments were performed. Prevalence of hearing loss was 78% (25/32) in the +P group and 71% (20/28) in the +S group at baseline, declining to 52% (28/54) in the +P groups and 56% (33/59) in the +S group at age 36 months. At primary endpoint age 18 months, prevalence of moderate (disabling) hearing loss was 21% (9/42) in the +P group and 41% (20/49) in the +S group (difference -19%; (95% confidence interval (CI) [-38, -1], p = 0.07) and prevalence of no hearing loss was 36% (15/42) in the +P group and 16% (8/49) in the +S group (difference 19%; (95% CI [2, 37], p = 0.05). At subsequent time points, prevalence of moderate hearing loss remained lower in the +P group: differences -3%; (95% CI [-23, 18], p = 1.00 at age 24 months), -12%; (95% CI [-30, 6], p = 0.29 at age 30 months), and -9%; (95% CI [-23, 5], p = 0.25 at age 36 months). A major limitation was the small sample size, hence low power to reach statistical significance, thereby reducing confidence in the effect size.

conclusionsIn this study, we observed a high prevalence and persistence of moderate (disabling) hearing loss throughout early childhood. We found a lower prevalence of moderate hearing loss and correspondingly higher prevalence of no hearing loss in the +P group, which may have substantial benefits for high-risk children, their families, and society, but warrant further investigation.

trial registrationClinicalTrials.gov NCT01735084 and NCT01174849.

Indexed as

Hearing LossOtitis MediaPneumococcal VaccinesAustraliaChild, PreschoolFemaleHumansImmunization ScheduleInfantMalePneumococcal InfectionsPrevalenceVaccines, Conjugate10-valent pneumococcal conjugate vaccine13-valent pneumococcal vaccinePneumococcal VaccinesVaccines, Conjugate

Identifiers

PMID38829821
PMCPMC11146696

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.