Back to resultsClostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Primary Purpose
Clostridium Difficile Associated Disease
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Clostridium difficile Vaccine
Placebo
Sponsored by
About this trial
This is an interventional other trial for Clostridium Difficile Associated Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female adults
- Aged 65 to 85 years
Exclusion Criteria:
- 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 medical disorders
- Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
- Subjects with congenital or acquired immunodeficiency disorders
- Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
- Active or treated leukemia or lymphoma or bone marrow disorder
- Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
- Abnormality in screening hematology and/or blood chemistry laboratory values
Sites / Locations
- SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
- SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Low-dose C. difficile Vaccine (accelerated schedule)
High-dose C. difficile Vaccine (accelerated schedule)
Placebo (accelerated schedule)
Low-dose C. difficile Vaccine (non-accelerated schedule)
High-dose C. difficile Vaccine (non-accelerated schedule)
Placebo (non-accelerated schedule)
Arm Description
Outcomes
Primary Outcome Measures
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
Secondary Outcome Measures
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations
Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels
Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A
Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B
Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively
Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels
Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels
Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02725437
Brief Title
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Associated Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose C. difficile Vaccine (accelerated schedule)
Arm Type
Experimental
Arm Title
High-dose C. difficile Vaccine (accelerated schedule)
Arm Type
Experimental
Arm Title
Placebo (accelerated schedule)
Arm Type
Placebo Comparator
Arm Title
Low-dose C. difficile Vaccine (non-accelerated schedule)
Arm Type
Experimental
Arm Title
High-dose C. difficile Vaccine (non-accelerated schedule)
Arm Type
Experimental
Arm Title
Placebo (non-accelerated schedule)
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile Vaccine
Intervention Description
0.5 mL intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.5 mL intramuscular injection
Primary Outcome Measure Information:
Title
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
Time Frame
Up to 14 days after each vaccination
Title
Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
Time Frame
Up to 14 days after each vaccination
Title
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Time Frame
From the first vaccination up to 28 days after the last vaccination
Title
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Time Frame
From the first vaccination until 6 months after the last vaccination
Title
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
Time Frame
7 days or 14 days after each vaccination
Secondary Outcome Measure Information:
Title
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations
Time Frame
Up to 6 months after dose 3
Title
Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels
Time Frame
Up to 6 months after dose 3
Title
Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels
Time Frame
Up to 6 months after dose 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female adults
Aged 65 to 85 years
Exclusion Criteria:
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 medical disorders
Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
Subjects with congenital or acquired immunodeficiency disorders
Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
Active or treated leukemia or lymphoma or bone marrow disorder
Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
Abnormality in screening hematology and/or blood chemistry laboratory values
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-0004
Country
Japan
Facility Name
SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30962095
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5091010&StudyName=A%20Phase%201%2C%20Placebo-controlled%2C%20Randomized%2C%20Observer-blinded%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20And%20Immunogenicity%20Of%20Two%203-dose%20Regimens%20Of%20Clostridium%20Difficile%20Vaccine%20Administered%20In%20Healthy%20Japanese%20Adults%20Aged%2065%20To%2085%20Years.
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5091010&StudyName=A+Phase+1%2C+Placebo-controlled%2C+Randomized%2C+Observer-blinded+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Immunogenicity+Of+Two+3-dose+Regimens+Of+Clostridium+Difficile+Vaccine+Administered+In+Healthy+Japanese+Adults+Aged+65+To+85+Years.
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
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