2021
DOI: 10.1186/s12887-021-02552-z
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Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

Abstract: Background Aboriginal 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 previ… Show more

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Cited by 15 publications
(12 citation statements)
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“…Hib was dramatically suppressed in the postvaccine era, and other capsular types are expected to evolve into common causative agents. 10,11 However, we identified only two encapsulated isolates (one a and one c). This is consistent with previous reports that NTHi has mainly been identified in AOM and chronic otitis media.…”
Section: Discussionmentioning
confidence: 87%
“…Hib was dramatically suppressed in the postvaccine era, and other capsular types are expected to evolve into common causative agents. 10,11 However, we identified only two encapsulated isolates (one a and one c). This is consistent with previous reports that NTHi has mainly been identified in AOM and chronic otitis media.…”
Section: Discussionmentioning
confidence: 87%
“…At later ages vaccine group differences in hearing persisted. Analysis stratified by the primary course head-to-head and combination schedules (the PREVIX_COMBO RCT) [5] suggested that slightly better hearing in the +P group was present across all primary schedules and was greatest in the SSSP+P versus SSSP+S comparison. These unique findings are difficult to explain and should be interpreted with caution as not all randomised participants received hearing assessments.…”
Section: Discussionmentioning
confidence: 99%
“…At primary endpoint age 18 months, prevalence of moderate (disabling) hearing loss was 21% and 41% in the +P and +S groups, respectively (difference -19% [95% confidence interval -38, -1], p=0.07) and prevalence of normal hearing was 36% and 16%, respectively (difference 19% [95%CI 2, 37], p=0.05). At subsequent timepoints prevalence of moderate hearing loss remained lower in the +P group at -3% [95% CI -23, 18] at age 24 months, -12% [95%CI -30, 6] at 30 months, and -9% [95%CI - 23,5] at 36 months. Interpretation: This study provides first evidence of the high prevalence and persistence of mild and moderate hearing loss throughout early childhood.…”
Section: Abstract 296 Words Introductionmentioning
confidence: 99%
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“…Acquisition of nasopharyngeal NTHi and non-vaccine serotypes 22 was associated with OM onset within weeks of birth in all PCV schedule groups. 18,34 Follow up to 3 years of age showed that OM persists causing chronic disabling hearing loss throughout early years for an average of 80% children. 35 This brings us back to the Hearing for Learning Initiative.…”
mentioning
confidence: 99%