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NCT02117570 · ClinicalTrials.gov registry record · Phase 2
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
A Phase 2 study of Clostridium Difficile Associated Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
- 12
- Study locations
NCT02117570: Completed Phase 2 study of Clostridium Difficile Associated Disease, sponsored by Pfizer.
NCT02117570 is a Phase 2 study of Clostridium Difficile Associated Disease that has completed, run by Pfizer. The registered enrollment target is 185 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117570, a Phase 2 study of Clostridium Difficile Associated Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
- 12
- Study locations
Study 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. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
Primary Outcome
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Clostridium difficile vaccine
Study Locations (12)
North Carolina
- PMG Research of Charlotte - Charlotte
- PMG Research of Wilmington, LLC - Wilmington
- PMG Research of Winston-Salem - Winston-Salem
Texas
- Benchmark Research - Austin
- Benchmark Research - San Angelo
- Clinical Trials of Texas, Inc. - San Antonio
Georgia
- Meridian Clinical Research - Savannah
- Clinical Research Atlanta - Stockbridge
Nebraska
- Meridian Clinical Research - Norfolk
- Meridian Clinical Research, LLC - Omaha
Florida
- Avail Clinical Research, LLC - DeLand
Nevada
- Clinical Research Center of Nevada, LLC - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT02117570 record still lists
NCT02117570 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% 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.
NCT02117570 lists 12 locations in 6 states (North Carolina, Texas, Georgia).
Frequently Asked Questions
What is clinical trial NCT02117570 about?
NCT02117570 is a clinical study titled "A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.". This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
What is the current status of trial NCT02117570?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2014-07. Estimated completion is 2015-12.
What conditions does trial NCT02117570 study?
This clinical trial studies the following conditions: Clostridium Difficile Associated Disease.
What interventions are being tested in trial NCT02117570?
The interventions under investigation include: Placebo (BIOLOGICAL), Clostridium difficile vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02117570?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02117570 being conducted?
This trial has 12 study locations across Florida, Georgia, Nebraska, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02117570's enrollment target sits among peer trials
185 357th of 2000 higher than 1,641 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
COMPLETED · Phase 1
-
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
COMPLETED · Phase 3
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