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A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

Last updated on May 2, 2019

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Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720 United States
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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- Healthy male and female subjects

- Aged 65 to 85 years

Additional Inclusion Criteria for the extension Stage:

- Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in
the original portion of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Proven or suspected prior episode of Clostridium difficile associated diarrhea

- Unstable chronic medical condition

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

- Serious chronic disorders

- Congenital or acquired immunodeficiency disorders

- Rheumatologic disorders or other illnesses requiring chronic treatment with known
immunosuppressant medications.

- Active or treated leukemia or lymphoma or bone marrow disorder

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

Additional Exclusion Criteria for the Extension Stage:

- Subjects originally randomized to placebo during the original portion of the study.

- Subjects who have already completed Visit 9 prior to study unblinding.

NCT02561195
Pfizer
Active, not recruiting
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

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

Pfizer Clinical Trials Contact Center

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[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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