Study: NCT01018641

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA3Ag vaccine
Description: In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm~In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab samples
Description: Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA3Ag followed by Placebo
Description: In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm~In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab samples
Description: Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Blood draw
Description: Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Colonization swab samples
Description: Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA3Ag with no booster in stage 2
Description: In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm~In stage 2 the subject will receive no vaccine.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab samples
Description: Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Placebo with no booster in stage 2
Description: In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.~In stage 2 the subject will receive no vaccine.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Blood draw
Description: Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Colonization swab samples
Description: Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.