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Vaccines and Related Biological Products Advisory Committee (VRBPAC)May 21, 2002Prevnar?, Pneumococcal Conjugate Vaccine 7-valent, for the Prevention of Acute Otitis Media?;Review Team;Proposed Indication;Regulatory Background;Global Issues;Comments from Medical Community:Correspondence to New England Journal of Medicine;Clinical Studies Reviewed;Outline of FDA Presentation;Finnish OM Study—Primary Objective ;Finnish OM Study—Secondary Objectives ;Finnish OM Study: Elements of the Study Design;Finnish OM Study: Vaccine Schedule and Concurrent Immunizations;Finnish OM study ;Finnish OM Study:Clinical Definition of Acute Otitis Media ;Finnish OM Study: AOM Efficacy Endpoints;Finnish OM Study- Definition of Primary Endpoint ;Finnish OM Study:Primary Endpoint Definition ;Finnish OM Study-Analysis of Primary Endpoint;Finnish OM Study-Definitions of Follow-up Periods;Finnish OM Study:Selected Population Characteristics ;Finnish OM Study-Primary Analysis, AOM due to Vaccine Serotypes;Finnish OM Study-AOM due to Individual Vaccine Serotypes, (Intent-to-treat);Finnish OM Study-Secondary Analyses, First and Subsequent AOM Episodes due to Vaccine Serotypes;Finnish OM Study-Efficacy for All Culture-Confirmed Pneumococci, Regardless of Serotype;Finnish OM Study-Efficacy for Vaccine-Related Serotypes;Finnish OM Study-AOM due to Individual Vaccine-Related Serotypes, (Intent-to-treat);Finnish Otitis Media Study-Efficacy for Vaccine-Unrelated Pneumococcal Serotypes;Finnish Otitis Media Study-Efficacy for Recurrent AOM *;Finnish Otitis Media Study-Efficacy for Other Planned Analyses;Finnish OM Study-Efficacy for Nasopharyngeal Carriage of Vaccine Serotypes (per protocol);Finnish OM Study—Serum Geometric Mean Antibody Concentration (GMC) After 3rd and 4th Doses;Finnish OM Study—Serum Antibody Concentrations (GMC) and Serotype-Specific Efficacy;Finnish Otitis Media Study—Invasive Disease Due to Pneumococcus;Finnish Otitis Media Study: Review Issues
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