Abstract
BackgroundAboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months.MethodsIn an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM).ResultsBetween September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM.ConclusionsDespite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life.Trial registrationACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.
Highlights
Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage
Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to 13-valent pneumococcal conjugate vaccine (PCV13) at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life
In remote Northern Territory (NT) communities, longitudinal birth cohort studies conducted in the pre- and post- 7-valent pneumococcal conjugate vaccine (PCV7) eras and including a maternal pneumococcal polysaccharide vaccination trial all found early nasopharyngeal colonisation and concomitant onset of otitis media (OM) within weeks of birth [3,4,5]
Summary
Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Australian Aboriginal and non-Aboriginal data were included in Oceania, combined and weighted by population size. In remote Northern Territory (NT) communities, longitudinal birth cohort studies conducted in the pre- and post- 7-valent pneumococcal conjugate vaccine (PCV7) eras and including a maternal pneumococcal polysaccharide vaccination trial all found early nasopharyngeal colonisation and concomitant onset of otitis media (OM) within weeks of birth [3,4,5]. A West Australian study conducted in the early years of the PCV7 era found that prevalence of OM and hearing loss were around 40% during first year of life [6]. Recent analyses using data-linkage has provided evidence that Aboriginal children with a history of hearing loss on entering school are at increased risk of vulnerability on entering school, [7] poor school attendance [8] and performance, [9] and substantiated child maltreatment [10]
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