GSK3878858A / GSK - LARVOL DELTA

Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted S. aureus Vaccine in Adults with Recent Skin And Soft Tissue Infections: An Observer-blind, Randomized, Placebo-controlled, Multinational Phase 1/2 Trial. (PubMed, Clin Infect Dis) - P2 | "In participants with recent history of SA-SSTI, SA5Ag-Adj vaccine had an acceptable safety profile, induced robust functional immune responses against CP5, CP8, and Hla antigens, but did not reduce the rate of recurrent SA-SSTIs at 12 months from last dose."

First-in-human • Journal • P1/2 data • Infectious Disease

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) (clinicaltrials.gov) - P2 | N=227 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed | N=632 ➔ 227

Enrollment change • Trial completion • Infectious Disease

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) (clinicaltrials.gov) - P2 | N=632 | Active, not recruiting | Sponsor: GlaxoSmithKline | Phase classification: P1/2 ➔ P2

Phase classification • Infectious Disease

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) (clinicaltrials.gov) - P1/2 | N=632 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Mar 2024 | Trial primary completion date: Jun 2024 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

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) (clinicaltrials.gov) - P1/2; N=632; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: May 2023 ➔ Mar 2024; Trial primary completion date: May 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Infectious Disease

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) 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) (clinicaltrials.gov) - P1/2; N=632; Recruiting; Sponsor: GlaxoSmithKline; Phase classification: P2 ➔ P1/2

Clinical • Phase classification • Infectious Disease

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) 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) (clinicaltrials.gov) - P2; N=632; Recruiting; Sponsor: GlaxoSmithKline; Phase classification: P1 ➔ P2

Clinical • Phase classification • Infectious Disease

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) 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) (clinicaltrials.gov) - P1; N=632; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Nov 2022 ➔ May 2023; Trial primary completion date: Nov 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Infectious Disease

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) 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) (clinicaltrials.gov) - P1; N=632; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open