Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age

Completed · Phase 3 · Has a placebo group

Conditions studied: Clostridium Difficile Associated Disease

In brief

This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Key facts

Study ID

NCT03579459

Run by

Pfizer

People needed

1317

Starts

2018-07-31

Expected to finish

2019-08-06

Last updated by the study team

2023-01-19

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Evidence of a personally signed and dated informed consent document.
• 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.

You may not qualify if…

• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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