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

A J Leach; N Wilson; B Arrowsmith; J Beissbarth; E K Mulholland; M Santosham; P J Torzillo; P McIntyre; H Smith-Vaughan; S A Skull; V M Oguoma; M Chatfield; D Lehmann; M J Binks; P V Licciardi; R Andrews; T Snelling; V Krause; J Carapetis; A B Chang; P S Morris

doi:10.1016/j.ijporl.2023.111776

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

Int J Pediatr Otorhinolaryngol. 2023 Dec:175:111776. doi: 10.1016/j.ijporl.2023.111776. Epub 2023 Nov 6.

Authors

A J Leach¹, N Wilson², B Arrowsmith³, J Beissbarth², E K Mulholland⁴, M Santosham⁵, P J Torzillo⁶, P McIntyre⁷, H Smith-Vaughan², S A Skull⁸, V M Oguoma⁹, M Chatfield¹⁰, D Lehmann¹¹, M J Binks², P V Licciardi¹², R Andrews¹³, T Snelling¹⁴, V Krause¹⁵, J Carapetis¹⁶, A B Chang¹⁷, P S Morris¹⁸

Affiliations

¹ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia. Electronic address: amanda.leach@menzies.edu.au.
² Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
³ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
⁴ London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
⁵ Departments of International Health and Pediatrics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center for Indigenous Health, Johns Hopkins University, Baltimore, USA.
⁶ Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Department of Medicine, University of Sydney, Sydney, New South Wales, Australia.
⁷ Discipline of Child and Adolescent Health, University of Sydney, New South Wales, Australia; Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
⁸ Department of Infectious Diseases, Perth Children's Hospital, Perth, Western Australia, Australia.
⁹ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Poche Centre for Indigenous Health, The University of Queensland, Brisbane, Queensland, Australia.
¹⁰ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
¹¹ Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
¹² London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
¹³ Office of the Chief Health Officer, Queensland Health, Brisbane, Queensland, Australia.
¹⁴ School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
¹⁵ Centre for Disease Control (CDC)-Environmental Health, Northern Territory Health, Darwin, Northern Territory, Australia.
¹⁶ Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia; Department of Infectious Diseases, Perth Children's Hospital, Perth, Western Australia, Australia.
¹⁷ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.
¹⁸ Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Royal Darwin Hospital, Paediatrics Department, Darwin, Northern Territory, Australia.

PMID: 37951020
DOI: 10.1016/j.ijporl.2023.111776

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.

Keywords: Aboriginal; Australia; Child; First nations; Otitis media; Pneumococcal conjugate vaccine; Randomised controlled trial.

MeSH terms

Australia / epidemiology
Child
Child, Preschool
Deafness*
Humans
Infant
Infant, Newborn
Otitis Media* / drug therapy
Otitis Media* / epidemiology
Otitis Media* / prevention & control
Pneumococcal Infections* / drug therapy
Pneumococcal Infections* / epidemiology
Pneumococcal Infections* / prevention & control
Pneumococcal Vaccines
Randomized Controlled Trials as Topic
Streptococcus pneumoniae
Vaccines, Conjugate / therapeutic use

Substances

Vaccines, Conjugate
Pneumococcal Vaccines