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Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

Last updated on February 21, 2019

FOR MORE INFORMATION
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.
Clostridium Difficile Associated Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Healthy male and female adults

2. Aged 65 to 85 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Proven or suspected prior episode of Clostridium difficile associated diarrhea

2. Unstable chronic medical condition

3. Disease requiring significant change in therapy or hospitalization for worsening
disease within 8 weeks before receipt of study vaccine

4. Serious chronic medical disorders

5. Bleeding diathesis or condition associated with prolonged bleeding time that may
contraindicate intramuscular injection

6. Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine-related components

7. Subjects with congenital or acquired immunodeficiency disorders

8. Subjects with rheumatologic disorders or other illnesses requiring chronic treatment
with known immunosuppressant medications

9. Active or treated leukemia or lymphoma or bone marrow disorder

10. Residence in a nursing home or other long-term care facility, or requirement for
semiskilled nursing care or assisted living

11. Abnormality in screening hematology and/or blood chemistry laboratory values

NCT02725437
Pfizer
Completed
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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