456
Participants
Start Date
August 31, 2011
Primary Completion Date
January 31, 2013
Study Completion Date
January 31, 2013
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 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 time points throughout the study.
SA4Ag vaccine mid dose
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood sample
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 time points throughout the study.
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 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 time points throughout the study.
Placebo
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Blood draw
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 time points throughout the study.
Buffalo Clinical Research Center, LLC, Buffalo
SNBL Clinical Pharmacology Center, Inc., Baltimore
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary
Broward Research Group, Hollywood
Miami Research Associates, South Miami
Vanderbilt University Medical Center, Nashville
New Orleans Center for Clinical Research, Knoxville
Volunteer Research Group, Knoxville
Kentucky Pediatric/Adult Research, Bardstown
Cincinnati Children's Hospital Medical Center, Cincinnati
Cincinnati Children's Hospital Medical Center, Cincinnati
Prism Research, Saint Paul
Vince and Associates Clinical Research, Overland Park
Texas Center for Drug Development, Inc., Houston
Benchmark Research, Austin
Roberta Braun, M.D., Austin
Lead Sponsor
Pfizer
INDUSTRY