226
Participants
Start Date
November 16, 2022
Primary Completion Date
March 12, 2024
Study Completion Date
March 12, 2024
Sa-5Ag half dose non-adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag full dose non-adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag half dose adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag full dose adjuvanted
A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
Placebo
One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo Groups 1 to 3 (Dose-escalation epoch) and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo Group 4 (Dose-escalation epoch) and Group PoP: Placebo, administered intramuscularly.
Lead Sponsor
GlaxoSmithKline
INDUSTRY