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Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

Last updated on February 21, 2019

Study Location
Broward Research Group
Hollywood, Florida, 33024 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcal Infections
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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(ICD) indicating that the subject has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures, including daily completion of the e-diary for
10 days after study vaccination. 3. Healthy male and female subjects, aged 18 to at enrollment, as determined by medical history, physical examination, and the clinical
judgment of the investigator to be eligible for the study. Subjects with preexisting
chronic medical conditions determined to be stable may be included. 4. Male and female
subjects of childbearing potential and at risk for pregnancy must agree to use a highly
effective method of contraception throughout the study. 5. Subject must be able to be
contacted by telephone during study participation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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change in therapya or hospitalization for worsening disease within 3 months before receipt
of investigational product. 2. Serious chronic medical disorders including metastatic
malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental
oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac
disease, or any other disorder that in the investigator's opinion precludes the subject
from participating in the study. 3. Congenital or acquired immunodeficiency disorder,
rheumatologic disorder, or other illness requiring chronic treatment with known
immunosuppressant medications, including monoclonal antibodies, within the year prior to
enrollment or the use of systemic corticosteroids (equivalent of ?10 mg/day of prednisone)
for >14 days within 30 days prior to study enrollment. 4. History of leukemia, lymphoma, or
underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder)
or history of bone marrow transplant. 5. Malignancy that required treatment with
chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies
within 24 months prior to study enrollment. 6. Any infection proven or suspected to be
caused by S. aureus within 6 months preceding study vaccination. 7. Previous administration
of S. aureus vaccine or S. aureus/Candida vaccine. 8. Any contraindication to vaccination
or vaccine components, including previous anaphylactic reaction to any vaccine or
vaccine-related components. 9. Bleeding diathesis or condition associated with prolonged
bleeding time that would contraindicate intramuscular injection. 10. Donation of blood
volume of 250 mL or greater (excluding protocol-required blood collection) or donation of
plasma within 3 months prior to enrollment through conclusion of the study. 11. Receipt of
blood products or immunoglobulins (including monoclonal antibodies) within 6 months before
enrollment or anticipated through conclusion of the subject's participation. 12. Subjects
who are investigational site staff members directly involved in the conduct of the study
and their family members, site staff members otherwise supervised by the investigator, or
subjects who are Pfizer employees directly involved in the conduct of the study. 13.
Participation in other studies involving investigational drug(s) (Phases 1-4) within 30
days before the current study begins and/or during study participation. Participation in
observational studies is permitted. 14. Pregnant female subjects; breastfeeding female
subjects; male subjects with partners currently pregnant; male and female subjects of
childbearing potential and at risk for pregnancy who are unwilling or unable to use a
highly effective method of contraception as outlined in this protocol for the duration of
the study. 15. Residence in a nursing home or long-term care facility or requirement for
semiskilled nursing care. An ambulatory subject who is a resident of a retirement home or
village is eligible for the trial. 16. Subjects with known active disease with human
immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). 17.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this

Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years


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