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Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan

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ClinicalTrials.gov Identifier: NCT01896830
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
  • 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 ]
    Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
  • 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 ]
    Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
  • 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 ]
    Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan
Official Title  ICMJE Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • Biological: Clostridium difficile Toxoid Vaccine
    0.5 mL, intramuscular
  • Biological: 0.9% normal saline
    0.5 mL, intramuscular
    Other Name: NaCl
Study Arms  ICMJE
  • Experimental: Vaccine Group
    Participants will receive the candidate C. difficile toxoid vaccine
    Intervention: Biological: Clostridium difficile Toxoid Vaccine
  • Placebo Comparator: Placebo Group
    Participants will receive a placebo vaccine
    Intervention: Biological: 0.9% normal saline
Publications * Matsuoka O, Patel DM, Sasaki S, Oka H, Sasaki T, Pietrobon PJ, Laot T, Bouckenooghe A, Menezes J, de Bruyn G. Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. Hum Vaccin Immunother. 2018 Feb 1;14(2):322-328. doi: 10.1080/21645515.2017.1395538. Epub 2017 Dec 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2013)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896830
Other Study ID Numbers  ICMJE CDI19 (DFI13360)
U1111-1127-7547 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur K.K
PRS Account Sanofi
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP