Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
Public ClinicalTrials.gov record NCT01230957. 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
Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives: * To describe the safety profile of subjects in each of the study groups. * To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups. Observational Objective: * To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
Study identification
- NCT ID
- NCT01230957
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 650 participants
Conditions and interventions
Conditions
Interventions
- Clostridium difficile toxoids A and B (Low-dose with adjuvant) Biological
- Clostridium difficile toxoids A and B (Low-dose without adjuvant) Biological
- Clostridium difficile toxoids A and B (high-dose with adjuvant) Biological
- Clostridium difficile toxoids A and B (high-dose without adjuvant) Biological
- Placebo: 0.9% normal saline Biological
Biological
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- 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
- Oct 2010 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Mar 2013 (Actual)
- Last update posted
- Jul 18, 2018
2010 – 2013
United States locations
- U.S. sites
- 30
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Redding | California | 96001 | — |
| Not listed | Bristol | Connecticut | 06010 | — |
| Not listed | Stamford | Connecticut | 06905 | — |
| Not listed | Clearwater | Florida | 33756 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Port Orange | Florida | 32127 | — |
| Not listed | St. Petersburg | Florida | 33709 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Idaho Falls | Idaho | 83404 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Brockton | Massachusetts | 02301 | — |
| Not listed | Troy | Michigan | 48098 | — |
| Not listed | Neptune City | New Jersey | 07753 | — |
| Not listed | Binghamton | New York | 13901 | — |
| Not listed | Endwell | New York | 13760 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Hickory | North Carolina | 28602 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Centerville | Ohio | 45459 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Uniontown | Pennsylvania | 15401 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Bristol | Tennessee | 37620 | — |
| Not listed | Salt Lake City | Utah | 84093 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | Richmond | Virginia | 23294 | — |
| Not listed | Williamsburg | Virginia | 23185 | — |
| Not listed | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01230957, 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 Jul 18, 2018 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01230957 live on ClinicalTrials.gov.