A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile Associated Disease

In brief

This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.

Key facts

Study ID

NCT02561195

Run by

Pfizer

People needed

300

Starts

2015-07-16

Expected to finish

2020-02-13

Last updated by the study team

2021-03-08

Who can join

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

You may qualify if…

• Healthy male and female subjects
• Aged 65 to 85 years
• Additional Inclusion Criteria for the extension Stage:
• Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.

You may not qualify if…

• 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 disorders
• Congenital or acquired immunodeficiency disorders
• Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications.
• Active or treated leukemia or lymphoma or bone marrow disorder
• Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components
• Additional Exclusion Criteria for the Extension Stage:
• Subjects originally randomized to placebo during the original portion of the study.
• Subjects who have already completed Visit 9 prior to study unblinding.

Where it is running

• Avail Clinical Research, LLC — DeLand, Florida, United States
• QPS-MRA, LLC (Broward Research Group) — Hollywood, Florida, United States
• QPS-MRA, LLC (Miami Research Associates) — South Miami, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Vince & Associates Clinical Research, Inc — Overland Park, Kansas, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Clinical Research Center of Nevada LLC — Las Vegas, Nevada, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Benchmark Research — Austin, Texas, United States
• Texas Center For Drug Development, Inc. — Houston, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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