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Published VersionCC BY V4.0, Open Access
Journal article
Otitis media at 6-monthly assessments of Australian First Nations children between ages 12-36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines
International Journal of Pediatric Otorhinolaryngology, Vol.175, pp.1-9
2023
PMID: 37951020
Abstract
Objectives
In remote communities of northern Australia, First Nations children with hearing loss are disproportionately at risk of poor school readiness and performance compared to their peers with no hearing loss. The aim of this trial is to prevent early childhood persisting otitis media (OM), associated hearing loss and developmental delay. To achieve this, we designed a mixed pneumococcal conjugate vaccine (PCV) schedule that could maximise immunogenicity and thereby prevent bacterial otitis media (OM) and a trajectory of educational and social disadvantage.
Methods
In two sequential parallel, open-label, randomised controlled trials, eligible infants were first allocated 1:1:1 to standard or mixed PCV primary schedules at age 28–38 days, then at age 12 months to a booster dose (1:1) of 13-valent PCV, PCV13 (Prevenar13®, +P), or 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine, PHiD-CV10 (Synflorix®, +S). Here we report findings of standardised ear assessments conducted six-monthly from age 12–36 months, by booster dose.
Results
From March 2013 to September 2018, 261 children were allocated to booster + P (n = 131) or + S (n = 130). There were no significant differences in prevalence of any OM diagnosis by booster dose or when stratified by primary schedule. We found high, almost identical prevalence of OM in both boost groups at each age (for example 88% of 129 and 91% of 128 children seen, respectively, at primary endpoint age 18 months, difference −3% [95% Confidence Interval −11, 5]). At each age prevalence of bilateral OM was 52%–78%, and tympanic membrane perforation was 10%–18%.
Conclusion
Despite optimal pneumococcal immunisation, the high prevalence of OM persists throughout early childhood. Novel approaches to OM prevention are needed, along with improved early identification strategies and evaluation of expanded valency PCVs.
Details
- Title
- Otitis media at 6-monthly assessments of Australian First Nations children between ages 12-36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines
- Authors
- A J Leach (Corresponding Author) - Charles Darwin UniversityNicole Wilson - Charles Darwin UniversityBeth Arrowsmith - Charles Darwin UniversityJ. Beissbarth - Menzies School of Health ResearchE. K. Mulholland - London School of Hygiene & Tropical MedicineMathuram Santosham - Johns Hopkins UniversityPaul J. Torzillo - The University of SydneyPeter McIntyre - University of OtagoHeidi C Smith-Vaughan - Charles Darwin UniversitySue A. Skull - Perth Children's HospitalVictor Oguoma - Charles Darwin UniversityMark D. Chatfield - Charles Darwin UniversityDeborah Lehmann - The Kids Research Institute AustraliaMichael J. Binks - Charles Darwin UniversityPaul V. Licciardi - London School of Hygiene & Tropical MedicineR. Andrews - Queensland HealthTom Snelling - The University of SydneyVicki Krause - Northern Territory Health ServicesJ. Carapetis - Perth Children's HospitalA. B. Chang - Queensland University of TechnologyPeter S Morris - Charles Darwin University
- Publication details
- International Journal of Pediatric Otorhinolaryngology, Vol.175, pp.1-9
- Publisher
- Elsevier Ltd
- Date published
- 2023
- DOI
- 10.1016/j.ijporl.2023.111776
- ISSN
- 1872-8464; 0165-5876
- PMID
- 37951020
- Copyright note
- © 2023 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
- Data Availability
- Data collected for the study that underlie the results reported in this Article, including individual participant data and a data dictionary defining each field in the set, will be made available after de-identification. No additional, related documents will be available, and the study protocols have been published. Data will be available up to 3 years after publication of this Article, upon request to the corresponding author. Data will be shared with investigators whose proposed use of the data has been approved by 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 Health Division's Australian First Nations Reference Group, for analyses that meet criteria for excellence in research with Aboriginal and Torres Strait Islander people, and with an institutional-signed and investigator signed data sharing research agreement.
- Grants
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991112951302621
- Output Type
- Journal article
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- Domestic collaboration
- International collaboration
- Web Of Science research areas
- Otorhinolaryngology
- Pediatrics
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