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NCT01706367 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Clostridium Difficile Associated Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 192
- Enrollment target
- 4
- Study locations
NCT01706367 is a Phase 1 study of Clostridium Difficile Associated Disease that has completed, run by Pfizer. The registered enrollment target is 192 participants. The trial reports 4 study locations across 3 states.
The verdict
NCT01706367, a Phase 1 study of Clostridium Difficile Associated Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 192 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study aims to assess the immune response to the C difficile vaccine.
Conditions Studied
Interventions
- BIOLOGICAL C. difficile vaccine
- BIOLOGICAL C. difficile vaccine +adjuvant
Study Locations (4)
Florida
- Pfizer Investigational Site - Pembroke Pines
- Pfizer Investigational Site - South Miami
Kansas
- Pfizer Investigational Site - Overland Park
North Carolina
- Pfizer Investigational Site - Cary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01706367
The ClinicalTrials.gov registry entry for NCT01706367 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Difficile Associated Disease appearing as the primary indexed condition, and to 2 interventions - of which C. difficile vaccine is the first listed.
NCT01706367 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Florida, Kansas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01706367 about?
NCT01706367 is a clinical study titled "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". This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study ...
What is the current status of trial NCT01706367?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 192 participants. The study started on 2012-09. Estimated completion is 2014-01.
What conditions does trial NCT01706367 study?
This clinical trial studies the following conditions: Clostridium Difficile Associated Disease.
What interventions are being tested in trial NCT01706367?
The interventions under investigation include: C. difficile vaccine (BIOLOGICAL), C. difficile vaccine +adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01706367?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01706367 being conducted?
This trial has 4 study locations across Florida, Kansas, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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