Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
NCT ID: NCT03579459
Last Updated: 2023-01-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1317 participants
INTERVENTIONAL
2018-07-31
2019-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
NCT02117570
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
NCT02561195
Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
NCT03918629
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
NCT02052726
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
NCT01230957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clostridium difficile vaccine Lot 1
Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Clostridium difficile vaccine Lot 2
Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Clostridium difficile vaccine Lot 3
Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Placebo
Normal saline solution (0.9% sodium chloride)
placebo
Normal saline solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
placebo
Normal saline solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing and able to comply with study procedures.
* Healthy adults 65 to 85 years of age.
* Male subjects or female subjects who are not of childbearing potential.
* Ability to be contacted by telephone during study participation.
Exclusion Criteria
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry through conclusion of the study.
* Previous administration of an investigational C difficile vaccine or C difficile monoclonal antibody therapy.
* Proven or suspected prior episode of C difficile infection.
* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of investigational product.
* Serious chronic medical disorders, including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease.
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Subjects who may be unable to respond to vaccination due to:
* Congenital or acquired immunodeficiency.
* Receipt of systemic corticosteroids (greater than or equal to 20 mg/day of prednisone or equivalent) for greater than or equal to 14 days within 28 days of enrollment.
* Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
* Underlying bone marrow disorder treated within the past year, such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.
* Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.
* Receipt of blood products or immunoglobulins within 6 months before enrollment through conclusion of the study.
* Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living. An ambulatory subject who lives in an autonomous manner in a retirement home or village is eligible for the trial.
* A known infection with human immunodeficiency virus (HIV).
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavioral or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
* Female subjects of childbearing potential; pregnant female subjects; breastfeeding female subjects; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
65 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Paradigm Clinical Research Centers, Inc.
Redding, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Advanced Clinical Research
Meridian, Idaho, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Amici Clinical Research
Raritan, New Jersey, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Medical Research South, LLC
Goose Creek, South Carolina, United States
Benchmark Research
Austin, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc./ Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Christensen S, Bouguermouh S, Ilangovan K, Pride MW, Webber C, Lockhart SP, Shah R, Kitchin N, Lamberth E, Zhang H, Gao Q, Brock L, Anderson AS, Gruber WC. A phase 3 study evaluating the lot consistency, immunogenicity, safety, and tolerability of a Clostridioides difficile vaccine in healthy adults 65 to 85 years of age. Vaccine. 2023 Dec 7;41(50):7548-7559. doi: 10.1016/j.vaccine.2023.11.003. Epub 2023 Nov 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B5091008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.