Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
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|ClinicalTrials.gov Identifier: NCT01887912|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : February 6, 2018
The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for CDI where there is a substantial unmet medical need.
- 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 subjects aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.
- 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.
- To describe the immunogenicity to toxin A and toxin B in the subset of subjects at specific time points.
- To describe the safety profile of all subjects who receive at least 1 injection.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: C. difficile Toxoid Vaccine Biological: Placebo: 0.9% normal saline||Phase 3|
The study is designed as an event-driven group sequential protocol with 4 interim analyses at defined information milestones and a final analysis when a specific number of clinical endpoints are reached.
Subjects will be randomly assigned to receive either the candidate vaccine or a placebo that will be administered in a 3-dose schedule.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||May 16, 2018|
|Estimated Study Completion Date :||May 16, 2018|
Experimental: C. difficile Vaccine Group
Participants will receive 1 injection of the C. difficile toxoid vaccine at Days 0, 7, and 30, respectively.
Biological: C. difficile Toxoid Vaccine
0.5 mL, Intramuscular
Placebo Comparator: Placebo Vaccine Group
Participants will receive 1 injection of placebo (0.9% normal saline) at Days 0, 7, and 30, respectively.
Biological: Placebo: 0.9% normal saline
0.5 mL, Intramuscular
- Number of symptomatic PCR-confirmed primary CDI cases after at least one injection [ Time Frame: Up to 3 years post-vaccination 1 ]Presence of ≥ 3 loose stools for ≤ 24 hours and loose stools lasting ≥ 24 hours, and stool sample positive for C. difficile PCR, or confirmatory test of pseudomembranous colitis diagnosed through colonoscopy, and, if available, provision of a stool sample for PCR-testing
- Number of symptomatic PCR-confirmed primary CDI cases after 3 injections [ Time Frame: Up to 3 years post-vaccination 3 ]
- Number of symptomatic PCR-confirmed primary CDI cases after at least 2 injections [ Time Frame: Up to 3 years post-vaccination 2 ]
- Number of symptomatic PCR-confirmed primary CDI cases after 3 injections since enrollment and within 3 years after the third injection [ Time Frame: Up to 3 years post-vaccination 3 ]
- Number of severe PCR-confirmed primary CDI cases [ Time Frame: Up to 3 years post-vaccination 3 ]A severe case is defined when a subject has one or more of the following; fever ≥38.5°C, WBC count ≥ 15,000 cells/mm3 (if available), ileus, pseudomembranous colitis, serum albumin <3 g/dl, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis
- Maximum number of loose stools per day associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]Effect of the vaccine on reduction of loose stool frequency
- CDI episode/illness duration associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]Duration is calculated as (clinical cure date - clinical case date + 1)
- Immunogenicity to toxins A and toxin B [ Time Frame: Day 0 to Day and every 6 months up to 3 years ]Antibody concentrations against toxins A and B measured by ELISA and antibody titers measured by toxin neutralization assay in subsets of subjects
- Number of participants reporting solicited injection site and systemic reactions [ Time Frame: Day 0 to Day 6 after each injection ]Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887912
Show 335 Study Locations
|Study Director:||Medical Director||Sanofi Pasteur Inc.|