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

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NCT02725437

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, 130-0004 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

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.
Show details

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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Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Clostridium Difficile Associated Disease
  • Biological: Clostridium difficile Vaccine
    0.5 mL intramuscular injection
  • Biological: Placebo
    0.5 mL intramuscular injection
  • Experimental: Low-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (accelerated schedule)
    Intervention: Biological: Placebo
  • Experimental: Low-dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (non-accelerated schedule)
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 25, 2017
February 25, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy male and female adults
  2. Aged 65 to 85 years

Exclusion Criteria:

  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
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02725437
B5091010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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