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

NCT02725437

Last updated date
Study Location
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, 130-0004, Japan
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Clostridium Difficile Associated Disease
Intervention  ICMJE
  • Biological: Clostridium difficile Vaccine
    0.5 mL intramuscular injection
  • Biological: Placebo
    0.5 mL intramuscular injection
Study Arms  ICMJE
  • 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
Publications * Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2016)
128
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02725437
Other Study ID Numbers  ICMJE B5091010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP