GSK Staph: Phase I, observer-blind, randomized, 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 50 years of age with a recent S. aureus skin and soft tissue infection (SSTI)

  • STATUS
    Not Recruiting
Updated on 28 September 2022

Summary

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.

Description

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

Details
Condition Soft Tissue Infections
Clinical Study IdentifierTX299752
Last Modified on28 September 2022

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