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Published VersionCC BY V4.0, Open Access
Journal article
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
PLoS Medicine, Vol.21(6), pp.1-15
2024
PMID: 38829821
Abstract
Background
In 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 findings
In 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.
Conclusions
In 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 registration
ClinicalTrials.gov NCT01735084 and NCT01174849
Details
- Title
- 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
- Authors
- Amanda Jane Leach (Corresponding Author) - Charles Darwin UniversityNicole Wilson - Charles Darwin UniversityBeth Arrowsmith - Charles Darwin UniversityJemima Beissbarth - Charles Darwin UniversityKim Mulholland - London School of Hygiene & Tropical MedicineMathuram Santosham - Johns Hopkins UniversityPaul J. Torzillo - Royal Prince Alfred HospitalPeter McIntyre - The University of SydneyHeidi C Smith-Vaughan - Charles Darwin UniversitySue A. Skull - The University of Western AustraliaVictor Oguoma - Charles Darwin UniversityMark D. Chatfield - Charles Darwin UniversityDeborah Lehmann - The University of Western AustraliaChristopher G. Brennan-Jones - The University of Western AustraliaMichael J. Binks - Charles Darwin UniversityPaul V. Licciardi - London School of Hygiene & Tropical MedicineRoss M Andrews - Queensland HealthTom Snelling - The University of SydneyVicki Krause - Northern Territory Health ServicesJonathan R Carapetis - The University of Western AustraliaAnne B Chang - Charles Darwin UniversityPeter S Morris - Charles Darwin University
- Publication details
- PLoS Medicine, Vol.21(6), pp.1-15
- Publisher
- Public Library of Science
- Date published
- 2024
- DOI
- 10.1371/journal.pmed.1004375
- ISSN
- 1549-1676; 1549-1277
- PMID
- 38829821
- Copyright note
- © 2024 Leach et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
- Data Availability
- De-identified data that underlie the results reported in this Article are available upon request. Please contact the Senior Data Manager at the Menzies School of Health Research (datamanagement@menzies.edu.au). However, as per the IRB-approved consent protocol agreement, the data can only be used for this study due to participants' consent restrictions. The data thus can only be shared with other researchers for study verification/validation purposes. Please note that to gain access to the data, approval is required from the ethics committees of NT Health, Menzies School of Health Research, WA Department of Health, and WA Aboriginal Health Ethics Committee, and approved by the Menzies’ Child and Maternal Health Division’s Australian First Nations Reference Group. Researchers will also need to put in place an institutional-signed and investigator-signed data sharing research agreement.
- Grants
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991113151502621
- Output Type
- Journal article
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