- Healthy males and healthy postmenopausal females, aged 65 to
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.
- Available for the entire duration of the study, and able to comply with scheduled
visits, study plan, laboratory tests, and other study procedures including completion
of the electronic diary (e diary) from Day 1 to Day 14 following vaccination.
- Able to be contacted by telephone during study participation.
- Male subjects who, in the opinion of the investigator, are biologically capable of
fathering children, and who are sexually active with women of childbearing potential
must agree to use a highly effective method of contraception throughout the study.
- Unstable chronic medical condition or disease requiring significant change in therapy
or hospitalization for worsening disease within 3 months before receipt of study
- Serious chronic medical disorders or any disorder that in the investigator's opinion
precludes the subject from participating in the study.
- Donation of blood volume of 250 mL or greater or donation of plasma within 3 months
prior to enrollment through conclusion of the study.
- Bleeding condition associated with prolonged bleeding time that may contraindicate
intramuscular injection or blood draw including subjects taking anticoagulant,
antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30
days before enrollment through completion of Visit 6 (Day 29).
- Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine related components.
- Immunocompromised persons or subjects currently on immunosuppressive therapy or with a
history of immunosuppressive therapy. History of immune-modifying drugs.
- Previous administration of S. aureus vaccination.
- Any infection proven or suspected to be caused by S. aureus within 6 months preceding
- Receipt of blood products or immunoglobulins (including monoclonal antibodies) within
12 months before enrollment through conclusion of the study.
- Participation in other investigational or interventional studies within 30 days before
the current study begins and/or during study participation. Participation in purely
observational studies is acceptable.
- Subjects who are investigational site staff members or subjects who are immediate
family members (first-degree relatives) of investigational site staff members or
Pfizer employees directly involved in the conduct of the trial.
- 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.
- A Mini-Mental State Examination (MMSE) score of ?21.
- For Phase 1 subjects only, any abnormality in screening hematology, coagulation,
and/or blood chemistry laboratory values except as noted in protocol
- Subjects with known active disease with human immunodeficiency virus (HIV), hepatitis
B virus (HBV), and/or hepatitis C virus (HCV), or Phase 1 subjects with a positive
screening test for HIV, HBV and/or HCV.
- 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 study.
- Planned surgical procedure within 30 days following vaccination.