Abstract
BackgroundIn 2001 when 7-valent pneumococcal conjugate vaccine (PCV7) was introduced, almost all (90%) young Australian Indigenous children living in remote communities had some form of otitis media (OM), including 24% with tympanic membrane perforation (TMP). In late 2009, the Northern Territory childhood vaccination schedule replaced PCV7 with 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10).MethodsWe conducted regular surveillance of all forms of OM in children in remote Indigenous communities between September 2008 and December 2012. This analysis compares children less than 36 months of age who received a primary course of at least two doses of PCV7 or PHiD-CV10, and not more than one dose of another pneumococcal vaccine.ResultsMean ages of 444 PCV7- and 451 PHiD-CV10-vaccinated children were 20 and 18 months, respectively. Bilaterally normal middle ears were detected in 7% and 9% respectively. OM with effusion was diagnosed in 41% and 51% (Risk Difference 10% [95% Confidence Interval 3 to 17] p = 0.002), any suppurative OM (acute OM or any TMP) in 51% versus 39% (RD −12% [95% CI −19 to −5] p = 0.0004], and TMP in 17% versus 14% (RD −3% [95% CI −8 to 2] p = 0.2), respectively. Multivariate analyses described a similar independent negative association between suppurative OM and PHiD-CV10 compared to PCV7 (Odds Ratio = 0.6 [95% CI 0.4 to 0.8] p = 0.001). Additional children in the household were a risk factor for OM (OR = 2.4 [95% CI 2 to 4] p = 0.001 for the third additional child), and older age and male gender were associated with less disease. Other measured risk factors were non-significant. Similar clinical results were found for children who had received non-mixed PCV schedules.ConclusionsOtitis media remains a significant health and social issue for Australian Indigenous children despite PCV vaccination. Around 90% of young children have some form of OM. Children vaccinated in with PHiD-CV10 had less suppurative OM than children vaccinated with PCV7. Ongoing surveillance during the PCV13 era, and trials of early intervention including earlier and mixed vaccine schedules are warranted.
Highlights
In 2001 when 7-valent pneumococcal conjugate vaccine (PCV7) was introduced, almost all (90%) young Australian Indigenous children living in remote communities had some form of otitis media (OM), including 24% with tympanic membrane perforation (TMP)
Community based surveillance pre- and post- introduction of seven-valent pneumococcal conjugate vaccine (PCV7) indicates that less than 10% of Australian Indigenous children living in remote Northern Territory (NT) communities have normal middle ears and around 20% have
Our primary hypotheses were that in children 6 months to 36 months of age the prevalence of TMP (AOMwiP, Dry perforation (DP) and chronic suppurative otitis media (CSOM)) would be less, and the prevalence of bilateral normal middle ears would be higher in PHiD-CV10 vaccinated children compared to 7-valent Pneumococcal conjugate vaccine (PCV7) vaccinated children
Summary
In 2001 when 7-valent pneumococcal conjugate vaccine (PCV7) was introduced, almost all (90%) young Australian Indigenous children living in remote communities had some form of otitis media (OM), including 24% with tympanic membrane perforation (TMP). In late 2009, the Northern Territory childhood vaccination schedule replaced PCV7 with 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10). Community based surveillance pre- and post- introduction of seven-valent pneumococcal conjugate vaccine (PCV7) indicates that less than 10% of Australian Indigenous children living in remote Northern Territory (NT) communities have normal middle ears and around 20% have may limit the extent and persistence of this benefit [7]. In addition to protection from three additional serotypes, clinical trial data suggested that the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) may protect against NTHi otitis media [8], Australian regulatory authorities have not approved a license indication for the latter [9]. Our primary hypotheses were that in children 6 months to 36 months of age the prevalence of TMP (AOMwiP, DP and CSOM) would be less, and the prevalence of bilateral normal middle ears would be higher in PHiD-CV10 vaccinated children compared to PCV7 vaccinated children
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