Infections, Soft Tissue Clinical Trial
Official title:
A Phase I/II, Observer-blind, Randomised, Placebo-controlled Study to Assess Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase in healthy adults safety and immunogenicity of 4 different compositions is assessed. After safety has been shown in this phase, in the second phase, proof of principle (PoP) phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the final composition of the vaccine is assessed.
n/a