Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01887912
First received: June 20, 2013
Last updated: May 11, 2017
Last verified: May 2017
  Purpose

The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile 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:

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 in the subset of subjects at specific time points.

Safety:

  • 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: 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 (Cdiffense™)

Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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: 16500
Study Start Date: July 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (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 4 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.

  Eligibility

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

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
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: NCT01887912

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Huntsville, Alabama, United States, 35803
Active, not recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Active, not recruiting
Flagstaff, Arizona, United States, 86001
Active, not recruiting
Phoenix, Arizona, United States, 85018
Active, not recruiting
Surprise, Arizona, United States, 85374
United States, Arkansas
Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Active, not recruiting
Bakersfield, California, United States, 93301
Active, not recruiting
Banning, California, United States, 92220
Active, not recruiting
Garden Grove, California, United States, 92844
Active, not recruiting
La Mesa, California, United States, 91942
Active, not recruiting
Los Angeles, California, United States, 90022
Investigational Site 051 Recruiting
Los Angeles, California, United States, 90027
Active, not recruiting
Modesto, California, United States, 95350
Active, not recruiting
Redding, California, United States, 96001
Active, not recruiting
Sacramento, California, United States, 95817
Active, not recruiting
Simi Valley, California, United States, 93065
Investigational Site 057 Recruiting
Stanford, California, United States, 94305
Active, not recruiting
Upland, California, United States, 91786
Active, not recruiting
Ventura, California, United States, 93003
United States, Connecticut
Active, not recruiting
Bristol, Connecticut, United States, 06010
Active, not recruiting
Danbury, Connecticut, United States, 06810
United States, Florida
Investigational Site 143 Recruiting
Bradenton, Florida, United States, 34209
Investigational Site 187 Recruiting
Brandon, Florida, United States, 33511
Investigational Site 075 Recruiting
Clearwater, Florida, United States, 33756
Active, not recruiting
Clearwater, Florida, United States, 33765
Investigational Site 055 Recruiting
Crystal River, Florida, United States, 34429
Active, not recruiting
DeLand, Florida, United States, 32720
Active, not recruiting
Gainesville, Florida, United States, 32607
Investigational Site 099 Recruiting
Hialeah, Florida, United States, 33012
Active, not recruiting
Jacksonville, Florida, United States, 32216
Active, not recruiting
Lauderdale Lakes, Florida, United States, 33319
Active, not recruiting
Miami, Florida, United States, 33165
Active, not recruiting
Orange Park, Florida, United States, 32073
Active, not recruiting
Pensacola, Florida, United States, 32504
Active, not recruiting
Port Saint Lucie, Florida, United States, 34987
Investigational Site 040 Recruiting
Saint Petersburg, Florida, United States, 33709
Active, not recruiting
Saint Petersburg, Florida, United States, 33713
Investigational Site 088 Recruiting
Sarasota, Florida, United States, 34239
Active, not recruiting
Tamarac, Florida, United States, 33321
Active, not recruiting
Tampa, Florida, United States, 33612
Active, not recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Active, not recruiting
Augusta, Georgia, United States, 30912
Active, not recruiting
Decatur, Georgia, United States, 30030
Active, not recruiting
Macon, Georgia, United States, 31201
Active, not recruiting
Savannah, Georgia, United States, 31406
United States, Idaho
Investigational Site 049 Recruiting
Idaho Falls, Idaho, United States, 83494
Active, not recruiting
Pocatello, Idaho, United States, 83201
United States, Illinois
Active, not recruiting
Evanston, Illinois, United States, 60201
Active, not recruiting
Peoria, Illinois, United States, 61602
Active, not recruiting
Peoria, Illinois, United States, 61614
United States, Indiana
Active, not recruiting
Anderson, Indiana, United States, 46011
United States, Iowa
Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Active, not recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Investigational Site 091 Recruiting
Metairie, Louisiana, United States, 70006
Active, not recruiting
New Orleans, Louisiana, United States, 70121
Active, not recruiting
Opelousas, Louisiana, United States, 70570
Active, not recruiting
Shreveport, Louisiana, United States, 71101
United States, Maine
Active, not recruiting
Auburn, Maine, United States, 04210
United States, Maryland
Active, not recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Investigational Site 002 Recruiting
Boston, Massachusetts, United States, 02215
Active, not recruiting
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Active, not recruiting
Ann Arbor, Michigan, United States, 48106
Active, not recruiting
Detroit, Michigan, United States, 48202
Active, not recruiting
Flint, Michigan, United States, 48504
Active, not recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Active, not recruiting
Kalamazoo, Michigan, United States, 49007
Active, not recruiting
Livonia, Michigan, United States, 48152
Active, not recruiting
Royal Oak, Michigan, United States, 48073
Active, not recruiting
Stevensville, Michigan, United States, 49127
Active, not recruiting
Troy, Michigan, United States, 48098
United States, Montana
Active, not recruiting
Butte, Montana, United States, 59701
United States, New Jersey
Active, not recruiting
Neptune City, New Jersey, United States, 07753
Active, not recruiting
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Active, not recruiting
Albuquerque, New Mexico, United States, 27103
Active, not recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Investigational Site 022 Recruiting
Endwell, New York, United States, 13760
Active, not recruiting
Rochester, New York, United States, 14621
Active, not recruiting
Rochester, New York, United States, 14642
Active, not recruiting
Syracuse, New York, United States, 13210
Active, not recruiting
The Bronx, New York, United States, 10467
Active, not recruiting
The Bronx, New York, United States, 10468
United States, North Carolina
Active, not recruiting
Asheville, North Carolina, United States, 28805
Active, not recruiting
Cary, North Carolina, United States, 27518
Active, not recruiting
Charlotte, North Carolina, United States, 28209
Active, not recruiting
Hickory, North Carolina, United States, 28602
Active, not recruiting
Raleigh, North Carolina, United States, 27612
Active, not recruiting
Raleigh, North Carolina, United States, 48202
Active, not recruiting
Statesville, North Carolina, United States, 28625
Active, not recruiting
Wilmington, North Carolina, United States, 28401
Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Active, not recruiting
Fargo, North Dakota, United States, 58104
Active, not recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Active, not recruiting
Canton, Ohio, United States, 44710
Active, not recruiting
Cincinnati, Ohio, United States, 45219
Active, not recruiting
Cleveland, Ohio, United States, 44106
Active, not recruiting
Cleveland, Ohio, United States, 44109
Active, not recruiting
Cleveland, Ohio, United States, 44118
Investigational Site 003 Recruiting
Columbus, Ohio, United States, 43215
Investigational Site 061 Recruiting
Dayton, Ohio, United States, 45419
Active, not recruiting
Dayton, Ohio, United States, 45428
Active, not recruiting
Kettering, Ohio, United States, 45429
Active, not recruiting
Marion, Ohio, United States, 43302
Active, not recruiting
Middletown, Ohio, United States, 45005
United States, Oregon
Active, not recruiting
Bend, Oregon, United States, 97701
United States, Pennsylvania
Active, not recruiting
Camp Hill, Pennsylvania, United States, 17011
Active, not recruiting
Hershey, Pennsylvania, United States, 17033
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15240
Investigational Site 083 Recruiting
Uniontown, Pennsylvania, United States, 15401
Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Investigational Site 020 Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Investigational Site 050 Recruiting
Pawtucket, Rhode Island, United States, 02860
Active, not recruiting
Providence, Rhode Island, United States, 02906
Active, not recruiting
Providence, Rhode Island, United States, 02908
United States, South Carolina
Active, not recruiting
Mount Pleasant, South Carolina, United States, 29464
Active, not recruiting
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Active, not recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Active, not recruiting
Franklin, Tennessee, United States, 37067
Active, not recruiting
Jackson, Tennessee, United States, 38305
Active, not recruiting
Nashville, Tennessee, United States, 37082
Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Active, not recruiting
Austin, Texas, United States, 78745
Active, not recruiting
Corpus Christi, Texas, United States, 78413
Active, not recruiting
Dallas, Texas, United States, 75216
Active, not recruiting
Fort Worth, Texas, United States, 76104
Active, not recruiting
Groesbeck, Texas, United States, 76642
Investigational Site 005 Recruiting
San Antonio, Texas, United States, 78229
Active, not recruiting
Tomball, Texas, United States, 77375
United States, Utah
Active, not recruiting
Orem, Utah, United States, 84058
Active, not recruiting
Salt Lake City, Utah, United States, 84124
United States, Virginia
Investigational Site 012 Recruiting
Lynchburg, Virginia, United States, 24501
Active, not recruiting
Williamsburg, Virginia, United States, 23185
Active, not recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Active, not recruiting
Spokane, Washington, United States, 99202
Active, not recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Active, not recruiting
Weston, Wisconsin, United States, 54476
Australia, New South Wales
Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Active, not recruiting
Cairns, Queensland, Australia, 4870
Active, not recruiting
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Active, not recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Active, not recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Active, not recruiting
Subiaco, Western Australia, Australia, 6008
Brazil
Active, not recruiting
Salvador, BA, Brazil, 40420-000
Active, not recruiting
Salvado, BA, Brazil, 41253-190
Active, not recruiting
Aparecida de Goiânia, GO, Brazil, 74935-530
Active, not recruiting
Belo Horizonte, MG, Brazil, 30150-221
Active, not recruiting
Belo Horizonte, MG, Brazil, 30190-130
Active, not recruiting
Juiz de For a, MG, Brazil, 36010-570
Active, not recruiting
Recife, PE, Brazil, 52020-010
Active, not recruiting
Curitiba, PR, Brazil, 80810-040
Active, not recruiting
Nova Iguaçu, RJ, Brazil, 26030-380
Active, not recruiting
Rio de Janeiro, RJ, Brazil, 22271-100
Active, not recruiting
Natal, RN, Brazil, 59025-600
Active, not recruiting
Canoas, RS, Brazil, 92425-900
Active, not recruiting
Porto Alegre, RS, Brazil, 90035-003
Active, not recruiting
Santo Andre, SP, Brazil, 09060-650
Active, not recruiting
Campinas, Brazil, 13020431
Canada, British Columbia
Active, not recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Active, not recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z IM9
Canada, Manitoba
Active, not recruiting
Winnipeg, Manitoba, Canada, R3A IR9
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Investigational Site 163 Recruiting
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
Active, not recruiting
Guelph, Ontario, Canada, N1H 1B1
Active, not recruiting
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Active, not recruiting
Pierrefonds, Quebec, Canada, H9H 4Y6
Investigational Site 152 Recruiting
Québec, Quebec, Canada, G1E 7G9
Active, not recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Investigational Site 161 Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Colombia
Active, not recruiting
Barranquilla, Alantico, Colombia
Active, not recruiting
Medellin, Antioquia, Colombia
Active, not recruiting
Bogota, Ditrito Capital, Colombia
Active, not recruiting
Bogota, Ditrito, Colombia
Active, not recruiting
Armenia, Quindio, Colombia
Active, not recruiting
Bucaramanga, Santander, Colombia
Active, not recruiting
Floridablanca, Santander, Colombia
Active, not recruiting
Yopal, Colombia
Costa Rica
Active, not recruiting
San José, Costa Rica, 250-1000
Dominican Republic
Active, not recruiting
Santo Domingo, Dominican Republic
Finland
Active, not recruiting
Espoo, Finland, FIN-02100
Active, not recruiting
Helsinki, Finland, FIN-00100
Active, not recruiting
Helsinki, Finland, FIN-00930
Active, not recruiting
Järvenpää, Finland, FIN-04400
Active, not recruiting
Kokkola, Finland, 67100
Active, not recruiting
Oulu, Finland, FIN-90220
Active, not recruiting
Pori, Finland, 28100
Active, not recruiting
Seinajoki, Finland, 60100
Active, not recruiting
Tampere, Finland, FIN-33100
Active, not recruiting
Turku, Finland, FIN-20520
Active, not recruiting
Vantaa, Finland, FIN-01300
France
Active, not recruiting
Dijon, France, 21079
Active, not recruiting
Lille, France, 49100
Active, not recruiting
Limoges, France, 87042
Active, not recruiting
Lyon, France, 69004
Active, not recruiting
Montpellier, France, 34295
Active, not recruiting
Orleans, France, 45100
Active, not recruiting
Paris, France, 75014
Active, not recruiting
Pringy, France, 21079
Active, not recruiting
Saint Etienne, France, 42055
Active, not recruiting
St Priest en Jarez, France, 42270
Active, not recruiting
Tourcoing, France, 59208
Active, not recruiting
Tours, France, 37044
Germany
Active, not recruiting
Munich, Bavaria, Germany, 81675
Active, not recruiting
Wurzburg, Bayern, Germany, 97074
Active, not recruiting
Deggingen, BW, Germany, 73326
Active, not recruiting
Cologne, NRW, Germany, 50937
Active, not recruiting
Leipzig, Sachsen, Germany, 04109
Active, not recruiting
Jena, Thuringia, Germany, 07747
Active, not recruiting
Berlin, Germany, 10629
Active, not recruiting
Berlin, Germany, 13347
Active, not recruiting
Essen, Germany, 45355
Active, not recruiting
Goch, Germany, 47574
Active, not recruiting
Hamburg, Germany, 20359
Active, not recruiting
Hamburg, Germany, 22143
Active, not recruiting
Leipzig, Germany, 97074
Guatemala
Active, not recruiting
Guatemala, Guatemala, 1001
Japan
Active, not recruiting
Aichi, Japan, 491-8551
Korea, Republic of
Active, not recruiting
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Active, not recruiting
Daegu, Jung-Gu, Korea, Republic of, 700-721
Active, not recruiting
Incheon, Namdong-gu, Korea, Republic of, 405-760
Active, not recruiting
Seoul, Seocho-gu, Korea, Republic of, 137-701
Active, not recruiting
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Active, not recruiting
Seoul, Seongbuk-gu, Korea, Republic of, 136-705
Active, not recruiting
Seoul, Seongdong-gu, Korea, Republic of, 132-792
Active, not recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Active, not recruiting
Busan, Korea, Republic of, 602-715
Active, not recruiting
Chungcheongbuk-do, Korea, Republic of, 361-711
Active, not recruiting
Gangwon-do, Korea, Republic of, 220-701
Active, not recruiting
Gyeonggi-do, Korea, Republic of, 425-707
Active, not recruiting
Gyeonggi-do, Korea, Republic of, 442-723
Active, not recruiting
Gyeonggi-do, Korea, Republic of, 443-380
Active, not recruiting
Incheon, Korea, Republic of, 400-711
Active, not recruiting
Seoul, Korea, Republic of, 134-701
Active, not recruiting
Seoul, Korea, Republic of, 150-950
Active, not recruiting
Seoul, Korea, Republic of, 152-703
Mexico
Active, not recruiting
Aguascalientes, AGS, Mexico, 20230
Active, not recruiting
Tijuana, Baja California, Mexico, 22320
Active, not recruiting
Mexico City, D.f., Mexico, 14000
Active, not recruiting
Mexico City, D.f., Mexico, 14080
Active, not recruiting
Guadalajara, JAL, Mexico, 44280
Active, not recruiting
Monterrey, NL, Mexico, 64460
Active, not recruiting
San Luis Potosi, SLP, Mexico, 78240
Active, not recruiting
Durango, Mexico, 34000
Active, not recruiting
Morelos, Mexico
Active, not recruiting
San Luis Potosi, Mexico, 78240
Panama
Active, not recruiting
Panama City, Panama
Peru
Active, not recruiting
Cercado de Lima, Lima, Peru
Active, not recruiting
Jesus Maria, Lima, Peru
Active, not recruiting
San Martín de Porres, Lima, Peru
Active, not recruiting
Surquillo, Lima, Peru
Active, not recruiting
Lima, Peru
Active, not recruiting
Piura, Peru
Active, not recruiting
Trujillo, Peru
Philippines
Active, not recruiting
Alabang, Philippines, 1770
Active, not recruiting
Dasmarinas, Philippines, 4114
Active, not recruiting
Manila, Philippines, 1000
Active, not recruiting
Manila, Philippines, 1004
Active, not recruiting
Pasig City, Philippines, 1600
Active, not recruiting
Quezon City, Philippines, 1100
Active, not recruiting
Quezon City, Philippines, 1101
Puerto Rico
Active, not recruiting
Bayamon, Puerto Rico, 00960
Active, not recruiting
Bayamon, Puerto Rico, 00961
Singapore
Active, not recruiting
Singapore, Singapore, 119074
Active, not recruiting
Singapore, Singapore, 169608
Active, not recruiting
Singapore, Singapore, 308433
Active, not recruiting
Singapore, Singapore, 768828
Spain
Active, not recruiting
Cordoba, Spain, 14004
Active, not recruiting
Terrassa, Spain, 08221
Active, not recruiting
Vigo, Spain, 36214
Sweden
Active, not recruiting
Göthenburg, SWE, Sweden, 41685
Active, not recruiting
Stockholm, Sweden, 11157
Active, not recruiting
Umea, Sweden, 90185
Taiwan
Active, not recruiting
Kaohsiung, Taiwan, 813
Active, not recruiting
New Taipei City, Taiwan, 22056
Active, not recruiting
New Taipei City, Taiwan, 23156
Active, not recruiting
Taichung City, Taiwan, 402
Active, not recruiting
Tainan, Taiwan, 710
Active, not recruiting
Taipei, Taiwan, 10002
Active, not recruiting
Tiachung, Taiwan, 404
United Kingdom
Active, not recruiting
Blackpool, United Kingdom, FY3 7EN
Active, not recruiting
Coventry, United Kingdom, CV2 2DX
Active, not recruiting
Harrow, United Kingdom, HA1 3UJ
Active, not recruiting
Lancashire, United Kingdom, FY3 8NR
Active, not recruiting
Liverpool, United Kingdom, L78XP
Active, not recruiting
London, United Kingdom, SW17 0RE
Active, not recruiting
Manchester, United Kingdom, M8 5RB
Active, not recruiting
Middlesex, United Kingdom, HA1 3UJ
Active, not recruiting
North Shields, United Kingdom, NE29 8NH
Active, not recruiting
Penzance, United Kingdom, TR19 7HX
Active, not recruiting
Stoke on Trent, United Kingdom, SR53SY
Active, not recruiting
West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov 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: May 11, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Clostridium difficile Toxoid Vaccine
Clostridium difficile infection
Cdiffense

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017