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Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)

Merck Sharp & Dohme LLC · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.
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