- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01896830
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan
July 13, 2018 updated by: Sanofi Pasteur, a Sanofi Company
Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.
Primary objectives:
- To describe the safety profile of all subjects who receive at least 1 injection
- To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomly assigned to receive the vaccine or placebo on the selected schedule.
Safety parameters, solicited injection site and systemic reactions will be collected for 6 days after each injection; unsolicited adverse events including serious adverse events will be collected up to Day 60 post-vaccination.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan, 532-0003
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult subjects aged 40 to 75 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Subject is 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 planned 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 vaccine.
- Planned receipt of any vaccine between study vaccinations and in the 4 weeks following the last trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
- Previous vaccination against C. difficile with either the trial vaccine another vaccine, or monoclonal antibodies
- Self-reported current or prior Clostridium difficile infection (CDI) episode
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- 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)
- Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Known systemic hypersensitivity to any of the vaccine components (including aluminum hydroxide, sodium citrate,sucrose, formaldehyde, sodium chloride), or history of a life-threatening reaction to a vaccine containing any of the same substances
- Known medical history or concomitant disease of thrombocytopenia
- 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
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Subjects who have any history of intestinal diverticular bleeding
- Subjects who have had surgery within the past three months for Gastro-Intestinal malignancy
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.5°C). A prospective subject 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
- Subject who has concomitant disease that, according to investigator's/sub-investigator's judgment, would adversely affect the safety of the subject in the study, e.g., cardiovascular disease, renal disease, hepatic disease, hematologic disease, and/or growth impairment
- Subject with a past history of convulsions
- Subject ineligible for participation in the study according to the investigator's/sub-investigator's judgment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Vaccine Group
Participants will receive the candidate C. difficile toxoid vaccine
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0.5 mL, intramuscular
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PLACEBO_COMPARATOR: Placebo Group
Participants will receive a placebo vaccine
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0.5 mL, intramuscular
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Time Frame: Day 0 up to Day 60 post-vaccination
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Solicited injection site reactions: Pain, Redness, and Swelling.
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
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Day 0 up to Day 60 post-vaccination
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Serum antibody concentrations to toxins A and B, measured by enzyme-linked immunosorbent assay (ELISA)
Time Frame: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
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Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
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Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
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Serum antibody titers against toxins A and B, measured by toxin neutralizing assay
Time Frame: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
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Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
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Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
July 8, 2013
First Submitted That Met QC Criteria
July 8, 2013
First Posted (ESTIMATE)
July 11, 2013
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 13, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDI19 (DFI13360)
- U1111-1127-7547 (OTHER: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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