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An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Herston, Queensland, 4029 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Staphylococcal Vaccines, Active Immunotherapy, Staphylococcal Skin Infections, Staphylococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire
duration of the study, able to be contacted by phone, and able to complete all study
procedures, including completion of an electronic diary (e-diary).

- Men and women who are able to have children, must use a reliable method of birth
control for the duration of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any major illness that would substantially increase the risk associated with
participation in the study, or interfere with the evaluation of the study objectives -
this is determined by the local physician.

- Donation of 250 mL or more of blood within the last 3 months.

- Condition associated with prolonged bleeding time, including subjects taking
anticoagulant medication or antiplatelet therapy.

- Any contraindication to vaccination or vaccine components.

- Immunocompromised persons and subjects who receive treatment with immunosuppressive
therapy.

- Previous administration of S. aureus vaccination.

- Receipt of blood products or immunoglobulins within 12 months prior to study

- Participation in another trial (not including observational trials) within the last 30
days.

- Study site personnel or immediate family members (first-degree relatives).

- Women who are pregnant (as determined by urine pregnancy test) or breast-feeding.

- Residence in a nursing home or long-term care facility or requirement for semiskilled
nursing care.

- For subjects aged 65 years or older, a Mini-Mental State Examination (MMSE) score of

NCT01018641
Pfizer
Completed
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

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