Streptococcus Pneumoniae Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of GEN-004, a Streptococcus Pneumoniae Protein Subunit Vaccine, in Adult Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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