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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01896830
First received: July 8, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Clostridium Difficile Infection
Biological: Clostridium difficile Toxoid Vaccine
Biological: 0.9% normal saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)


Enrollment: 102
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Group
Participants will receive the candidate C. difficile toxoid vaccine
Biological: Clostridium difficile Toxoid Vaccine
0.5 mL, intramuscular
Placebo Comparator: Placebo Group
Participants will receive a placebo vaccine
Biological: 0.9% normal saline
0.5 mL, intramuscular
Other Name: NaCl

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896830

Locations
Japan
Osaka, Japan, 532-0003
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur K.K
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01896830     History of Changes
Other Study ID Numbers: CDI19 (DFI13360), U1111-1127-7547
Study First Received: July 8, 2013
Last Updated: June 12, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Clostridium difficile infection
Clostridium difficile Toxoid Vaccine

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 01, 2014