Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials
Table 4
Vaccine efficacy values in the long-term follow-up of PCV clinical trials with otitis media as an endpoint [3, 13]. Adapted with permission from Fletcher and Fritzell, 2007 Elsevier Ltd. All rights reserved [7].
*See Table 1 for primary otitis media endpoint, otitis media definition, myringotomy criteria, and source of MEF in each study.
**Number of episodes in 6 months/number of episodes in 1 year. †In children diagnosed with “chronic otitis media with effusion.” ‡Efficacy against 10 or more episodes within 6 months. § Primary analysis set (see Section 3.5.2. FinOM Vaccine Trial). ¶ Secondary analysis set (see Section 3.5.2. FinOM Vaccine Trial). Reported values are rounded to whole numbers; dash line indicates not reported. CI: confidence interval; ITT: intent to treat; PP: per-protocol.