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SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

Last updated on March 14, 2019

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Study Location
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, 130-0004 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Japanese male and female adults aged 20 to

2. Determined as healthy by the investigator (Subjects with preexisting chronic medical
conditions determined to be stable may be included),

3. Must be available for the 12 month duration of the study,

4. Subjects must agree to use an acceptable method of birth control for 3 months after
study vaccination (if the subject or the subject's partner are/is capable of having
children).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine-related components,

2. Unstable or serious chronic medical condition that would increase the subject's risk
of participation,

3. Immune system suppression or treatment with medications that suppress the immune
system,

4. Receipt of blood products or immunoglobulins within the past 12 months,

5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,

6. A staff member at this site nor a relative of those site staff members, nor a
sponsor's employee directly involved in the conduct of this research study,

7. Living in a nursing home, long-term care facility or other institution or requiring
any types of nursing care,

8. A pregnant or a breast feeding woman.

NCT02492958
Pfizer
Completed
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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