140
Participants
Start Date
August 5, 2019
Primary Completion Date
May 10, 2022
Study Completion Date
May 10, 2022
C. difficile investigational vaccine based on the F2 antigen (GSK2904545A)
"Subjects in CDIFF Ag 18 - 45 Years and CDIFF Ag 50 - 70 Years Groups will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag vaccine.~The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose."
C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
"Subjects in CDIFF Ag + AS01B 50 - 70 Years Group will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag + AS01B vaccine.~The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose."
Placebo
Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval.
GSK Investigational Site, Ghent
Lead Sponsor
GlaxoSmithKline
INDUSTRY