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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01887912




Registration number
NCT01887912
Ethics application status
Date submitted
20/06/2013
Date registered
27/06/2013
Date last updated
28/03/2022

Titles & IDs
Public title
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Scientific title
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
Secondary ID [1] 0 0
2013-000775-32
Secondary ID [2] 0 0
H-030-014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - C. difficile Toxoid Vaccine
Other interventions - Placebo: 0.9% normal saline

Experimental: C. difficile Vaccine Group - Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

Placebo Comparator: Placebo Group - Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).


Other interventions: C. difficile Toxoid Vaccine
0.5 mL, Intramuscular

Other interventions: Placebo: 0.9% normal saline
0.5 mL, Intramuscular
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases
Timepoint [1] 0 0
Up to 3 years post injection 1
Secondary outcome [1] 0 0
Number of Participants With Severe PCR-Confirmed Primary CDI Cases
Timepoint [1] 0 0
Up to 3 years post injection 1
Secondary outcome [2] 0 0
Number of Participants With Loose Stool Episodes
Timepoint [2] 0 0
Up to 3 years post injection 1
Secondary outcome [3] 0 0
Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
Timepoint [3] 0 0
Up to 3 years post injection 1
Secondary outcome [4] 0 0
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Timepoint [4] 0 0
Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
Secondary outcome [5] 0 0
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Timepoint [5] 0 0
Day 60
Secondary outcome [6] 0 0
Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
Timepoint [6] 0 0
Day 0 and Day 60
Secondary outcome [7] 0 0
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Timepoint [7] 0 0
Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
Secondary outcome [8] 0 0
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
Timepoint [8] 0 0
Day 60
Secondary outcome [9] 0 0
Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
Timepoint [9] 0 0
Day 0 and Day 60
Secondary outcome [10] 0 0
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Timepoint [10] 0 0
Day 0 to Day 6 after any vaccination

Eligibility
Key inclusion criteria
- Aged >= 50 years on the day of inclusion

- Informed consent form had been signed and dated.

- Attended all scheduled visits and complied with all trial procedures.

- Covered by health insurance (if required).

- Must fulfill at least 1 of the following criteria

Risk Stratum 1:

- Had at least 2 hospital stays, each lasting at least >= 24 hours, in the 12 months
before enrollment, and

- Had received systemic (not topical) antibiotics in the 12 months before enrollment, or

Risk Stratum 2:

- Was anticipated to have an in-patient hospitalization for a planned surgical procedure
within 60 days of enrollment. The impending hospital stay was planned to be >= 72
hours for a surgery involving 1 of the following:

- Kidney/bladder/urinary system

- Musculoskeletal system

- Respiratory system

- Circulatory system

- Central nervous system.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant was pregnant, or lactating, or of childbearing potential (to be considered
of non-childbearing potential, a female must be post-menopausal for at least 1 year,
surgically sterile, or using an effective method of contraception or abstinence from
at least 4 weeks prior to the first vaccination and until at least 4 weeks after the
last vaccination).

- Participation in the 4 weeks preceding the first trial vaccination or participation
during the present trial period in another clinical trial investigating a vaccine,
drug, medical device, or medical procedure.

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for
influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes
monovalent pandemic influenza vaccines and multivalent influenza vaccines.

- Previous vaccination against C. difficile with either the trial vaccine, another
vaccine, or monoclonal antibodies.

- Diarrhea on day of enrollment.

- Self-reported current or prior CDI episode.

- Anticipated or current receipt of kidney dialysis treatment.

- History of gastrointestinal surgery for gastrointestinal malignancy (Note:
Colonoscopy, polypectomy, and appendectomy are not exclusion criteria).

- History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea
as a symptom), colostomy, or small or large intestine bowel surgery where resection
was performed.

- Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube
feeding).

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the trial or to a vaccine containing
any of the same substances.

- Self-reported thrombocytopenia, contraindicating intramuscular vaccination.

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.

- Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures in the opinion of the Investigator.

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion.

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>=
100.4°Fahrenheit]). A prospective participant should not be included in the study
until the condition has resolved or the febrile event has subsided.

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2018
Sample size
Target
Accrual to date
Final
9302
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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- Westmead
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Investigational Site 401 - Cairns
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- Woolloongabba
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Investigational Site 404 - Bedford Park
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Investigational Site 403 - Clayton
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- Nedlands
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- Subiaco
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2145 - Westmead
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4870 - Cairns
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4102 - Woolloongabba
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5042 - Bedford Park
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3168 - Clayton
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6009 - Nedlands
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6008 - Subiaco
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Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01887912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Sanofi Pasteur Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01887912