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NCT03579459 · ClinicalTrials.gov registry record · Phase 3
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
A Phase 3 study of Clostridium Difficile Associated Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,317
- Enrollment target
- 20
- Study locations
NCT03579459: Completed Phase 3 study of Clostridium Difficile Associated Disease, sponsored by Pfizer.
NCT03579459 is a Phase 3 study of Clostridium Difficile Associated Disease that has completed, run by Pfizer. The registered enrollment target is 1,317 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03579459, a Phase 3 study of Clostridium Difficile Associated Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,317 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
GMC was calculated as the mean of the assay results after making the logarithm transformation and then back transformation to its original scale. Confidence intervals (CIs) were back transformations of CIs based on the Student t distribution for the mean logarithm of the concentrations. Clostridium difficile toxin A and toxin B were inactivated by a combination of genetic mutations to decrease toxin activity and chemical treatments were done prior to final purification and formulation of the dru
Conditions Studied
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL Clostridium difficile vaccine
Study Locations (20)
Florida
- Clinical Research of South Florida - Coral Gables
- Avail Clinical Research, LLC - DeLand
- Research Centers of America, LLC - Hollywood
Georgia
- Atlanta Center for Medical Research - Atlanta
- Clinical Research Atlanta - Stockbridge
Nebraska
- Meridian Clinical Research, LLC - Norfolk
- Meridian Clinical Research, LLC - Omaha
North Carolina
- PMG Research of Charlotte, LLC - Charlotte
- PMG Research of Wilmington, LLC - Wilmington
Texas
- Benchmark Research - Austin
- Diagnostics Research Group - San Antonio
Alabama
- Coastal Clinical Research, Inc. - Mobile
California
- Paradigm Clinical Research Centers, Inc. - Redding
Hawaii
- East-West Medical Research Institute - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,317 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 3 |
What the finished NCT03579459 record still lists
NCT03579459 is an interventional study that assigns participants to a tested intervention. Its 1,317 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Clostridium Difficile Associated Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT03579459 names 20 study sites across 14 states, led by Florida, Georgia, Nebraska.
Frequently Asked Questions
What is clinical trial NCT03579459 about?
NCT03579459 is a clinical study titled "Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age". 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.
What is the current status of trial NCT03579459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,317 participants. The study started on 2018-07-31. Estimated completion is 2019-08-06.
What conditions does trial NCT03579459 study?
This clinical trial studies the following conditions: Clostridium Difficile Associated Disease.
What interventions are being tested in trial NCT03579459?
The interventions under investigation include: placebo (BIOLOGICAL), Clostridium difficile vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03579459?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03579459 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03579459's enrollment target sits among peer trials
1,317 185th of 2000 higher than 1,816 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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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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Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years
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