Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years

PHASE1CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

May 10, 2022

Study Completion Date

May 10, 2022

Conditions
Clostridium Infections
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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."

DRUG

Placebo

Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval.

Trial Locations (1)

9000

GSK Investigational Site, Ghent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY