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项与 Streptococcus pneumoniae 相关的临床试验A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GEN-004, a Pneumococcal Protein Subunit Vaccine, on Colonization Following Intranasal Challenge With S. Pneumoniae
This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will receive up to 3 doses at 4 week intervals.
Following the third dose, subjects will be inoculated intranasally with S. pneumoniae serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained pre-inoculation, and then 2, 7 and 14 days after inoculation.
Subjects will also be monitored for safety and tolerability throughout the dosing period, and then for 12 months after their last dose.
The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing colonization rates and magnitude of colonization following the S. pneumoniae challenge.
100 项与 Streptococcus pneumoniae 相关的临床结果
100 项与 Streptococcus pneumoniae 相关的转化医学
100 项与 Streptococcus pneumoniae 相关的专利(医药)
100 项与 Streptococcus pneumoniae 相关的药物交易