284
Participants
Start Date
August 31, 2012
Primary Completion Date
May 31, 2013
Study Completion Date
March 31, 2014
SA4Ag vaccine low dose
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood draw
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various timepoints.
SA4Ag vaccine mid dose
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood draw
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various timepoints.
SA4Ag vaccine high dose
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood draw
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various timepoints.
SA3Ag vaccine
Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
Blood sample
Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sample
Colonization swabs will be collected from all subjects at various timepoints.
Placebo
Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
Blood draw
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab samples
Colonization swabs will be collected from all subjects at various timepoints.
PMG Research of Raleigh, LLC, Cary
Broward Research Group, Hollywood
Miami Research Associates, South Miami
Vanderbilt University Medical Center, Nashville
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies, Cincinnati
Vince and Associates Clinical Research, Overland Park
Benchmark Research, Austin
Lead Sponsor
Pfizer
INDUSTRY