TY - JOUR
T1 - Otitis media at 6-monthly assessments of Australian First Nations children between ages 12–36 months
T2 - Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines
AU - Leach, A. J.
AU - Wilson, N.
AU - Arrowsmith, B.
AU - Beissbarth, J.
AU - Mulholland, E. K.
AU - Santosham, M.
AU - Torzillo, P. J.
AU - McIntyre, P.
AU - Smith-Vaughan, H.
AU - Skull, S. A.
AU - Oguoma, V. M.
AU - Chatfield, M.
AU - Lehmann, D.
AU - Binks, M. J.
AU - Licciardi, P. V.
AU - Andrews, R.
AU - Snelling, T.
AU - Krause, V.
AU - Carapetis, J.
AU - Chang, A. B.
AU - Morris, P. S.
N1 - Funding Information:
National Health and Medical Research Council (GNT605810, GNT1046999, GNT1120353).Sources of funding were the Australian NHMRC (National Health and Medical Research Council) (GNT605810, GNT1046999, GNT1120353) and GlaxoSmithKline (donation of reagents). AJL was not paid by any agency to write this Article. We thank the many families living in remote communities in northern Australia who participated in the PREVIX_COMBO and PREVIX_BOOST randomised controlled trials. We thank the many research nurses, audiologists, laboratory staff, and others who worked on the trials.
Publisher Copyright:
© 2023 The Authors
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Aboriginal
KW - Australia
KW - Child
KW - First nations
KW - Otitis media
KW - Pneumococcal conjugate vaccine
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85176222733&partnerID=8YFLogxK
U2 - 10.1016/j.ijporl.2023.111776
DO - 10.1016/j.ijporl.2023.111776
M3 - Article
AN - SCOPUS:85176222733
SN - 0165-5876
VL - 175
SP - 1
EP - 9
JO - International Journal of Pediatric Otorhinolaryngology
JF - International Journal of Pediatric Otorhinolaryngology
M1 - 111776
ER -
