Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Public ClinicalTrials.gov record NCT01887912. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: * To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \>= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: * To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. * To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: * To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: * To describe the safety profile of all participants who received at least 1 injection.
Study identification
- NCT ID
- NCT01887912
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 9,302 participants
Conditions and interventions
Conditions
Interventions
- C. difficile Toxoid Vaccine Biological
- Placebo: 0.9% normal saline Biological
Biological
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2013 (Actual)
- Primary completion
- Jun 12, 2018 (Actual)
- Completion
- Jun 12, 2018 (Actual)
- Last update posted
- Mar 28, 2022
2013 – 2018
United States locations
- U.S. sites
- 142
- U.S. states
- 37
- U.S. cities
- 127
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Huntsville | Alabama | 35803 | — |
| Investigational Site 104 | Mobile | Alabama | 36608 | — |
| Not listed | Flagstaff | Arizona | 86001 | — |
| Investigational Site 194 | Phoenix | Arizona | 85018 | — |
| Investigational Site 503 | Surprise | Arizona | 85374 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Bakersfield | California | 93301 | — |
| Not listed | Banning | California | 92220 | — |
| Not listed | Garden Grove | California | 92844 | — |
| Not listed | La Mesa | California | 91942 | — |
| Investigational Site 534 | Los Angeles | California | 90022 | — |
| Investigational Site 051 | Los Angeles | California | 90027 | — |
| Not listed | Modesto | California | 95350 | — |
| Not listed | Redding | California | 96001 | — |
| Not listed | Sacramento | California | 95817 | — |
| Investigational Site 504 | Simi Valley | California | 93065 | — |
| Investigational Site 057 | Stanford | California | 94305 | — |
| Investigational Site 176 | Upland | California | 91786 | — |
| Not listed | Ventura | California | 93003 | — |
| Investigational Site 546 | Wheat Ridge | Colorado | 90033 | — |
| Not listed | Bristol | Connecticut | 06010 | — |
| Not listed | Danbury | Connecticut | 06810 | — |
| Investigational Site 143 | Bradenton | Florida | 34209 | — |
| Investigational Site 187 | Brandon | Florida | 33511 | — |
| Investigational Site 075 | Clearwater | Florida | 33756 | — |
| Investigational Site 517 | Clearwater | Florida | 33765 | — |
| Investigational Site 055 | Crystal River | Florida | 34429 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Investigational Site 506 | Gainesville | Florida | 32607 | — |
| Investigational Site 099 | Hialeah | Florida | 33012 | — |
| Investigational Site 009 | Jacksonville | Florida | 32216 | — |
| Not listed | Lauderdale Lakes | Florida | 33319 | — |
| Not listed | Miami | Florida | 33165 | — |
| Not listed | Orange Park | Florida | 32073 | — |
| Investigational Site 112 | Pensacola | Florida | 32504 | — |
| Not listed | Port Saint Lucie | Florida | 34987 | — |
| Investigational Site 088 | Sarasota | Florida | 34239 | — |
| Investigational Site 040 | St. Petersburg | Florida | 33709 | — |
| Investigational Site 114 | St. Petersburg | Florida | 33713 | — |
| Not listed | Tamarac | Florida | 33321 | — |
| Not listed | Tampa | Florida | 33612 | — |
| Not listed | West Palm Beach | Florida | 33401 | — |
| Investigational Site 149 | Augusta | Georgia | 30912 | — |
| Investigational Site 529 | Decatur | Georgia | 30030 | — |
| Not listed | Macon | Georgia | 31201 | — |
| Investigational Site 010 | Savannah | Georgia | 31406 | — |
| Investigational Site 049 | Idaho Falls | Idaho | 83494 | — |
| Investigational Site 543 | Pocatello | Idaho | 83201 | — |
| Not listed | Evanston | Illinois | 60201 | — |
| Not listed | Peoria | Illinois | 61602 | — |
| Not listed | Peoria | Illinois | 61614 | — |
| Not listed | Anderson | Indiana | 46011 | — |
| Investigational Site 101 | Iowa City | Iowa | 52242 | — |
| Not listed | Topeka | Kansas | 66606 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Investigational Site 091 | Metairie | Louisiana | 70006 | — |
| Investigational Site 084 | New Orleans | Louisiana | 70121 | — |
| Not listed | Opelousas | Louisiana | 70570 | — |
| Investigational Site 077 | Shreveport | Louisiana | 71101 | — |
| Not listed | Auburn | Maine | 04210 | — |
| Not listed | Baltimore | Maryland | 21224 | — |
| Investigational Site 002 | Boston | Massachusetts | 02215 | — |
| Investigational Site 035 | West Roxbury | Massachusetts | 02132 | — |
| Investigational Site 190 | Ann Arbor | Michigan | 48106 | — |
| Investigational Site 175 | Detroit | Michigan | 48202 | — |
| Investigational Site 183 | Flint | Michigan | 48504 | — |
| Not listed | Grosse Pointe Woods | Michigan | 48236 | — |
| Not listed | Kalamazoo | Michigan | 49007 | — |
| Not listed | Livonia | Michigan | 48152 | — |
| Investigational Site 069 | Royal Oak | Michigan | 48073 | — |
| Not listed | Stevensville | Michigan | 49127 | — |
| Not listed | Troy | Michigan | 48098 | — |
| Not listed | Butte | Montana | 59701 | — |
| Investigational Site 189 | Hillsborough | New Jersey | 8844 | — |
| Investigational Site 044 | Neptune City | New Jersey | 07753 | — |
| Not listed | Teaneck | New Jersey | 07666 | — |
| Not listed | Albuquerque | New Mexico | 27103 | — |
| Not listed | Albuquerque | New Mexico | 87102 | — |
| Investigational Site 022 | Endwell | New York | 13760 | — |
| Not listed | Rochester | New York | 14621 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Syracuse | New York | 13210 | — |
| Not listed | The Bronx | New York | 10467 | — |
| Investigational Site 013 | The Bronx | New York | 10468 | — |
| Investigational Site 146 | Asheville | North Carolina | 28805 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Charlotte | North Carolina | 28209 | — |
| Not listed | Hickory | North Carolina | 28602 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Raleigh | North Carolina | 48202 | — |
| Not listed | Statesville | North Carolina | 28625 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site 031 | Fargo | North Dakota | 58104 | — |
| Not listed | Fargo | North Dakota | 58122 | — |
| Investigational Site 523 | Canton | Ohio | 44710 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Investigational Site 129 | Cleveland | Ohio | 44109 | — |
| Not listed | Cleveland | Ohio | 44118 | — |
| Investigational Site 003 | Columbus | Ohio | 43215 | — |
| Investigational Site 061 | Dayton | Ohio | 45419 | — |
| Not listed | Dayton | Ohio | 45428 | — |
| Not listed | Kettering | Ohio | 45429 | — |
| Not listed | Marion | Ohio | 43302 | — |
| Investigational Site 095 | Middletown | Ohio | 45005 | — |
| Not listed | Bend | Oregon | 97701 | — |
| Investigational Site 528 | Camp Hill | Pennsylvania | 17011 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Philadelphia | Pennsylvania | 19140 | — |
| Not listed | Pittsburgh | Pennsylvania | 15212 | — |
| Not listed | Pittsburgh | Pennsylvania | 15240 | — |
| Investigational Site 083 | Uniontown | Pennsylvania | 15401 | — |
| Not listed | West Reading | Pennsylvania | 19611 | — |
| Investigational Site 020 | Wilkes-Barre | Pennsylvania | 18711 | — |
| Investigational Site 050 | Pawtucket | Rhode Island | 02860 | — |
| Not listed | Providence | Rhode Island | 02906 | — |
| Not listed | Providence | Rhode Island | 02908 | — |
| Investigational Site 540 | Charleston | South Carolina | 29407 | — |
| Investigational Site 047 | Mt. Pleasant | South Carolina | 29464 | — |
| Investigational Site 180 | Spartanburg | South Carolina | 29303 | — |
| Investigational Site 086 | Rapid City | South Dakota | 57701 | — |
| Not listed | Franklin | Tennessee | 37067 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Nashville | Tennessee | 37082 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Investigational Site 544 | Austin | Texas | 78726 | — |
| Not listed | Corpus Christi | Texas | 78413 | — |
| Investigational Site 006 | Dallas | Texas | 75216 | — |
| Investigational Site 119 | Fort Worth | Texas | 76104 | — |
| Not listed | Groesbeck | Texas | 76642 | — |
| Investigational Site 193 | San Antonio | Texas | 78229 | — |
| Not listed | Tomball | Texas | 77375 | — |
| Investigational Site 135 | Orem | Utah | 84058 | — |
| Investigational Site 080 | Salt Lake City | Utah | 84124 | — |
| Investigational Site 012 | Lynchburg | Virginia | 24501 | — |
| Not listed | Williamsburg | Virginia | 23185 | — |
| Investigational Site 196 | Winchester | Virginia | 22601 | — |
| Not listed | Spokane | Washington | 99202 | — |
| Not listed | Tacoma | Washington | 98405 | — |
| Investigational Site 030 | Marshfield | Wisconsin | 54449 | — |
| Not listed | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 193 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01887912, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2022 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01887912 live on ClinicalTrials.gov.