Effectiveness of the 7- and 13-Valent Pneumococcal Conjugate Vaccines Against Vaccine-Serotype Otitis Media

Abstract

Abstract Background Despite the demonstrated impact of pneumococcal vaccine (PCV) implementation on otitis media (OM), demonstration of real-life serotype-specific effectiveness of the 7-valent and 13-valent PCVs (PCV7 and PCV13) is lacking owing to the paucity of culture-positive cases. Furthermore, prelicensure PCV13 efficacy against OM was not studied. Methods The study was conducted from October 2009 to July 2013. Case patients were children aged 5–35 months with OM (mostly complex OM [recurrent/nonresponsive, spontaneously draining, chronic with effusion]) from whom middle-ear fluid culture was obtained; controls were contemporary children with rotavirus-negative gastroenteritis in a prospective population-based rotavirus surveillance, from the same age group with similar ethnic distribution and geographic location. Vaccine effectiveness (VE) was estimated as 1 minus the odds ratio using unconditional logistic regression, adjusting for time since PCV implementation, age, and ethnicity. Results A total of 223 case patients and 1370 controls were studied. Serotypes 19F and 19A together caused 56.1% of all vaccine-type (VT) OM. VE of ≥2 PCV doses in children aged 5–35 months was demonstrated as follows: PCV7 against OM due to PCV7 serotypes, 57.2% (95% confidence interval, 6.0%–80.5%); PCV13 against OM due to PCV13 serotypes, 77.4% (53.3%–92.1%); PCV13 against OM due to the 6 additional non-PCV7 serotypes 67.4% (17.6%–87.1%); PCV13 against OM due to serotype 19F, 91.3% (1.4%–99.2%); and PCV13 against OM due to serotype 3, 89.0% (23.9%–98.4%). PCV7 and PCV13 VE against OM due to serotype 19A in children aged 12–35 months was 72.4% (95% confidence interval, 6.2%–91.9%) and 94.6% (33.9%–99.6%), respectively. Conclusions PCV7 and PCV13 were effective against complex OM caused by the targeted serotypes.