Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine

Summary

GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals. Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.

Timeline

Start

2013-11

Primary completion

2015-02

Completion

2015-02

Drugs

Indications