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Study of a Candidate Clostridium Difficile Toxoid Vaccine (Cdiffense) in Subjects at Risk for C. Difficile Infection

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: June 20, 2013
Last updated: August 8, 2016
Last verified: August 2016

The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile (Cdiffense) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a 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 subjects aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.

Secondary Objectives:


  • 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 Intervention Phase
Clostridium Difficile Infection
Biological: C. difficile Toxoid Vaccine
Biological: Placebo: 0.9% normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants with symptomatic PCR-confirmed primary CDI cases [ Time Frame: Up to 3 years post-vaccination 1 ]

Secondary Outcome Measures:
  • The number of participants with symptomatic PCR confirmed primary CDI cases after 3 injections [ Time Frame: Up to 3 years post-vaccination 3 ]
  • The number of participants with symptomatic PCR-confirmed primary CDI cases after 2 injections [ Time Frame: Up to 3 years post-vaccination 2 ]
  • The number of symptomatic PCR-confirmed primary CDI cases after 3 injections as a function of time since enrollment and within 3.0 years or 2.5 years in Stage 1 or Stage 2, respectively, after the third injection [ Time Frame: Up to 3 years post-vaccination 3 ]
  • Serum antibody concentrations against toxins A and B [ Time Frame: 60 Days post-vaccination 1 ]
  • 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 90 post-vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.

Estimated Enrollment: 15000
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C. difficile Vaccine Group
Participants will receive 1 injection of the C. difficile 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 0.9% normal saline at Days 0, 7, and 30, respectively.
Biological: Placebo: 0.9% normal saline
0.5 mL, Intramuscular

Detailed Description:

The study is designed as an event-driven group sequential protocol with 3 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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Aged ≥ 50 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
  • Covered by health insurance (if required)
  • Must fulfill at least 1 of the following criteria

Risk Stratum 1:

  • Has had at least 2 hospital stays, each lasting at least ≥ 24 hours, in the 12 months before enrollment, and
  • Has received systemic (not topical) antibiotics in the 12 months before enrollment, or

Risk Stratum 2:

  • Is anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay is 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.

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 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, 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°C [≥ 100.4°F]). 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01887912

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United States, Alabama
Huntsville, Alabama, United States, 35803
Mobile, Alabama, United States, 36608
United States, Arizona
Flagstaff, Arizona, United States, 86001
Phoenix, Arizona, United States, 85018
Surprise, Arizona, United States, 85374
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Bakersfield, California, United States, 93301
Banning, California, United States, 92220
Garden Grove, California, United States, 92844
La Mesa, California, United States, 91942
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90027
Modesto, California, United States, 95350
Redding, California, United States, 96001
Sacramento, California, United States, 95817
Simi Valley, California, United States, 93065
Stanford, California, United States, 94305
Upland, California, United States, 91786
Ventura, California, United States, 93003
United States, Connecticut
Bristol, Connecticut, United States, 06010
Danbury, Connecticut, United States, 06810
United States, Florida
Bradenton, Florida, United States, 34209
Brandon, Florida, United States, 33511
Clearwater, Florida, United States, 33756
Clearwater, Florida, United States, 33765
Crystal River, Florida, United States, 34429
DeLand, Florida, United States, 32720
Gainesville, Florida, United States, 32607
Hialeah, Florida, United States, 33012
Jacksonville, Florida, United States, 32216
Lauderdale Lakes, Florida, United States, 33319
Miami, Florida, United States, 33165
Orange Park, Florida, United States, 32073
Pensacola, Florida, United States, 32504
Port St. Lucie, Florida, United States, 34987
Sarasota, Florida, United States, 34239
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Savannah, Georgia, United States, 31406
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Idaho Falls, Idaho, United States, 83494
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Evanston, Illinois, United States, 60201
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Anderson, Indiana, United States, 46011
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Iowa City, Iowa, United States, 52242
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Topeka, Kansas, United States, 66606
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Louisville, Kentucky, United States, 40202
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Metairie, Louisiana, United States, 70006
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Auburn, Maine, United States, 04210
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Baltimore, Maryland, United States, 21224
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Boston, Massachusetts, United States, 02215
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Ann Arbor, Michigan, United States, 48106
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Butte, Montana, United States, 59701
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Rochester, New York, United States, 14642
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Asheville, North Carolina, United States, 28805
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Bend, Oregon, United States, 97701
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Camp Hill, Pennsylvania, United States, 17011
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Philadelphia, Pennsylvania, United States, 19140
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Pawtucket, Rhode Island, United States, 02860
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Mt. Pleasant, South Carolina, United States, 29464
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Rapid City, South Dakota, United States, 57701
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Franklin, Tennessee, United States, 37067
Jackson, Tennessee, United States, 38305
Nashville, Tennessee, United States, 37082
Nashville, Tennessee, United States, 37203
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Austin, Texas, United States, 78745
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Dallas, Texas, United States, 75216
Forth Worth, Texas, United States, 76104
Groesbeck, Texas, United States, 76642
San Antonio, Texas, United States, 78229
Tomball, Texas, United States, 77375
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Orem, Utah, United States, 84058
Salt Lake City, Utah, United States, 84124
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Lynchburg, Virginia, United States, 24501
Williamsburg, Virginia, United States, 23185
Winchester, Virginia, United States, 22601
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Spokane, Washington, United States, 99202
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Weston, Wisconsin, United States, 54476
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Cairns, Queensland, Australia, 4870
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Bedford Park, South Australia, Australia, 5042
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Clayton, Victoria, Australia, 3168
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Subiaco, Western Australia, Australia, 6008
Salvador, BA, Brazil, 40420-000
Salvado, BA, Brazil, 41253-190
Aparecida de Goiânia, GO, Brazil, 74935-530
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New Westminster, British Columbia, Canada, V3L 3W7
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Winnipeg, Manitoba, Canada, R3A IR9
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Halifax, Nova Scotia, Canada, B3K 6R8
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Kokkola, Finland, 67100
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Seinajoki, Finland, 60100
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Turku, Finland, FIN-20520
Vantaa, Finland, FIN-01300
Dijon, France, 21079
Lille, France, 49100
Limoges, France, 87042
Lyon, France, 69004
Montpellier, France, 34295
Orleans, France, 45100
Paris, France, 75014
Pringy, France, 21079
Saint Etienne, France, 42055
St Priest en Jarez, France, 42270
Tourcoing, France, 59208
Tours, France, 37044
Munich, Bavaria, Germany, 81675
Wurzburg, Bayern, Germany, 97074
Deggingen, BW, Germany, 73326
Cologne, NRW, Germany, 50937
Leipzig, Sachsen, Germany, 04109
Jena, Thuringia, Germany, 07747
Berlin, Germany, 10629
Berlin, Germany, 13347
Essen, Germany, 45355
Goch, Germany, 47574
Hamburg, Germany, 20359
Hamburg, Germany, 22143
Leipzig, Germany, 97074
Guatemala, Guatemala, 1001
Aichi, Japan, 491-8551
Korea, Republic of
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Daegu, Jung-Gu, Korea, Republic of, 700-721
Incheon, Namdong-gu, Korea, Republic of, 405-760
Seoul, Seocho-gu, Korea, Republic of, 137-701
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Seoul, Seongbuk-gu, Korea, Republic of, 136-705
Seoul, Seongdong-gu, Korea, Republic of, 132-792
Seoul, Songpa-gu, Korea, Republic of, 138-736
Busan, Korea, Republic of, 602-715
Chungcheongbuk-do, Korea, Republic of, 361-711
Gangwon-do, Korea, Republic of, 220-701
Gyeonggi-do, Korea, Republic of, 425-707
Gyeonggi-do, Korea, Republic of, 442-723
Gyeonggi-do, Korea, Republic of, 443-380
Incheon, Korea, Republic of, 400-711
Seoul, Korea, Republic of, 134-701
Seoul, Korea, Republic of, 150-950
Seoul, Korea, Republic of, 152-703
Aguascalientes, AGS, Mexico, 20230
Tijuana, Baja California, Mexico, 22320
Mexico City, D.f., Mexico, 14000
Mexico City, D.f., Mexico, 14080
Guadalajara, JAL, Mexico, 44280
Monterrey, NL, Mexico, 64460
San Luis Potosi, SLP, Mexico, 78240
Durango, Mexico, 34000
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San Luis Potosi, Mexico, 78240
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Lima, Peru
Piura, Peru
Trujillo, Peru
Alabang, Philippines, 1770
Dasmarinas, Philippines, 4114
Manila, Philippines, 1000
Manila, Philippines, 1004
Pasig City, Philippines, 1600
Quezon City, Philippines, 1100
Quezon City, Philippines, 1101
Puerto Rico
Bayamon, Puerto Rico, 00960
Bayamon, Puerto Rico, 00961
Singapore, Singapore, 119074
Singapore, Singapore, 169608
Singapore, Singapore, 308433
Singapore, Singapore, 768828
Cordoba, Spain, 14004
Terrassa, Spain, 08221
Vigo, Spain, 36214
Göthenburg, SWE, Sweden, 41685
Stockholm, Sweden, 11157
Umea, Sweden, 90185
Kaohsiung, Taiwan, 813
New Taipei City, Taiwan, 22056
New Taipei City, Taiwan, 23156
Taichung City, Taiwan, 402
Tainan, Taiwan, 710
Taipei, Taiwan, 10002
Tiachung, Taiwan, 404
United Kingdom
Blackpool, United Kingdom, FY3 7EN
Coventry, United Kingdom, CV2 2DX
Harrow, United Kingdom, HA1 3UJ
Lancashire, United Kingdom, FY3 8NR
Liverpool, United Kingdom, L78XP
London, United Kingdom, SW17 0RE
Manchester, United Kingdom, M8 5RB
Middlesex, United Kingdom, HA1 3UJ
North Shields, United Kingdom, NE29 8NH
Penzance, United Kingdom, TR19 7HX
Stoke on Trent, United Kingdom, SR53SY
West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT01887912     History of Changes
Other Study ID Numbers: H-030-014
2013-000775-32 ( EudraCT Number )
U1111-1127-7162 ( Other Identifier: WHO )
Study First Received: June 20, 2013
Last Updated: August 8, 2016

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

Additional relevant MeSH terms:
Communicable Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 24, 2017