Back to resultsA Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Primary Purpose
Clostridium Difficile
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
C. difficile vaccine with adjuvant
Placebo
C. difficile vaccine with adjuvant
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female adults aged 50 to 85 years at enrollment
Exclusion Criteria:
- Proven or suspected prior episode of Clostridium difficile associated diarrhea.
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
Sites / Locations
- Vince & Associates Clinical Research, Inc.
- Vince & Associates Clinical Research
- PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
- Carolina Phase I Research, LLC
- Texas Center for Drug Development, Inc.
- Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
- Manna Research Inc.
- Diex Research Montreal Inc
- Diex Research Sherbrooke Inc.
- Clinique Medicale St-Louis (recherche) Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm Label: Month 0, 1 and 3 Schedule
Day 1, 8, and 30 Schedule
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
Proportion 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.
Secondary Outcome Measures
Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02052726
Brief Title
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Official Title
A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 22, 2014 (Actual)
Primary Completion Date
May 2, 2015 (Actual)
Study Completion Date
May 5, 2015 (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
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Label: Month 0, 1 and 3 Schedule
Arm Type
Experimental
Arm Title
Day 1, 8, and 30 Schedule
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
C. difficile vaccine with adjuvant
Intervention Description
C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo administered at Month 0, 1, and 3.
Intervention Type
Biological
Intervention Name(s)
C. difficile vaccine with adjuvant
Intervention Description
C. difficile vaccine with adjuvant administered at day 1, 8, 30.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Placebo administered at Day 1, 8, and 30.
Primary Outcome Measure Information:
Title
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
Time Frame
7 days after vaccination
Title
Proportion 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
7 days after vaccination
Secondary Outcome Measure Information:
Title
Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
Time Frame
Up to 12 months post-dose 3
Title
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
Time Frame
Up to 12 months post-dose 3
Title
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).
Time Frame
Up to 12 months post-dose 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female adults aged 50 to 85 years at enrollment
Exclusion Criteria:
Proven or suspected prior episode of Clostridium difficile associated diarrhea.
Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
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
Vince & Associates Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Vince & Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Carolina Phase I Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Manna Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Diex Research Montreal Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Clinique Medicale St-Louis (recherche) Inc.
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
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