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  • Pneumococcal Conjugate Vaccines and Otitis Media, Sylvia Taylor, Paola Marchisio, Anne Vergison, William P. Hausdorff, and Mark Haggard
    International Journal of Otolaryngology
    Letter to the Editor (2 pages), Article ID 764573, Volume 2012 (2012)
    Published 13 November 2012
International Journal of Otolaryngology
Volume 2012, Article ID 312935, 15 pages
Review Article

Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials

Pfizer Specialty Care Business Unit-Vaccines, International Scientific & Clinical Affairs, Pfizer, Cedex 14, 75668 Paris, France

Received 15 September 2011; Revised 18 December 2011; Accepted 3 February 2012

Academic Editor: Joseph E. Kerschner

Copyright © 2012 Mark A. Fletcher and Bernard Fritzell. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Streptococcus pneumoniae is the predominant otitis media pathogen and its prevention through effective vaccination could diminish childhood illness and antibiotic use. This paper reviews 5 pneumococcal conjugate vaccine (PCV) trials that used otitis media as an endpoint: Northern California Kaiser Permanente (NCKP; vaccine, 7-valent PCV [PCV7]-CRM); Finnish Otitis Media (FinOM; vaccines, PCV7-CRM or PCV7-OMPC); Native American Trial (vaccine, PCV7-CRM); Pneumococcal Otitis Efficacy Trial (POET; vaccine, 11-valent PCV [PCV11]-PD). For the microbiological endpoint, vaccine efficacy against vaccine-serotype pneumococcal otitis media was about 60% across trials. Against the clinical endpoint of all episodes, vaccine efficacy was 7% (PCV7-CRM/NCKP), 6% (PCV7-CRM/FinOM), −1% (PCV7-OMPC/FinOM), and −0.4% (PCV7-CRM/Native American Trial); 34% against first episodes of ear, nose, and throat specialist-referral cases (PCV11-PD/POET). Both follow-up through 2 years of age, for the 5 trials, and long-term follow-up, for PCV7-CRM/NCKP and PCV7-CRM/FinOM, demonstrated greater vaccine efficacy against recurrent AOM and tympanostomy-tube placement, suggesting that vaccination against early episodes of AOM may prevent subsequent episodes of complicated otitis media. Although study designs varied by primary endpoint measured, age at follow-up, source of middle-ear fluid for culture, case ascertainment, and type of randomization, each clinical trial demonstrated vaccine efficacy against microbiological and/or clinical otitis media.