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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887912
First Posted: June 27, 2013
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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: Single (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 symptomatic PCR-confirmed primary CDI cases after at least one injection [ Time Frame: Up to 3 years post-vaccination 1 ]
    Presence of ≥ 3 loose stools for ≤ 24 hours and loose stools lasting ≥ 24 hours, and stool sample positive for C. difficile PCR, or confirmatory test of pseudomembranous colitis diagnosed through colonoscopy, and, if available, provision of a stool sample for PCR-testing


Secondary Outcome Measures:
  • Number of symptomatic PCR-confirmed primary CDI cases after 3 injections [ Time Frame: Up to 3 years post-vaccination 3 ]
  • Number of symptomatic PCR-confirmed primary CDI cases after at least 2 injections [ Time Frame: Up to 3 years post-vaccination 2 ]
  • Number of symptomatic PCR-confirmed primary CDI cases after 3 injections since enrollment and within 3 years after the third injection [ Time Frame: Up to 3 years post-vaccination 3 ]
  • Number of severe PCR-confirmed primary CDI cases [ Time Frame: Up to 3 years post-vaccination 3 ]
    A severe case is defined when a subject has one or more of the following; fever ≥38.5°C, WBC count ≥ 15,000 cells/mm3 (if available), ileus, pseudomembranous colitis, serum albumin <3 g/dl, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis

  • Maximum number of loose stools per day associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]
    Effect of the vaccine on reduction of loose stool frequency

  • CDI episode/illness duration associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]
    Duration is calculated as (clinical cure date - clinical case date + 1)

  • Immunogenicity to toxins A and toxin B [ Time Frame: Day 0 to Day and every 6 months up to 3 years ]
    Antibody concentrations against toxins A and B measured by ELISA and antibody titers measured by toxin neutralization assay in subsets of subjects

  • Number of participants reporting solicited injection site and systemic reactions [ Time Frame: Day 0 to Day 6 after each injection ]
    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 toxoid 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 placebo (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 (must include diarrhea as a symptom), 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887912


  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35803
Investigational Site 104
Mobile, Alabama, United States, 36608
United States, Arizona
Flagstaff, Arizona, United States, 86001
Investigational Site 194
Phoenix, Arizona, United States, 85018
Investigational Site 503
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
Investigational Site 534
Los Angeles, California, United States, 90022
Investigational Site 051
Los Angeles, California, United States, 90027
Modesto, California, United States, 95350
Redding, California, United States, 96001
Sacramento, California, United States, 95817
Investigational Site 504
Simi Valley, California, United States, 93065
Investigational Site 057
Stanford, California, United States, 94305
Investigational Site 176
Upland, California, United States, 91786
Ventura, California, United States, 93003
United States, Colorado
Investigational Site 546
Wheat Ridge, Colorado, United States, 90033
United States, Connecticut
Bristol, Connecticut, United States, 06010
Danbury, Connecticut, United States, 06810
United States, Florida
Investigational Site 143
Bradenton, Florida, United States, 34209
Investigational Site 187
Brandon, Florida, United States, 33511
Investigational Site 075
Clearwater, Florida, United States, 33756
Investigational Site 517
Clearwater, Florida, United States, 33765
Investigational Site 055
Crystal River, Florida, United States, 34429
DeLand, Florida, United States, 32720
Investigational Site 506
Gainesville, Florida, United States, 32607
Investigational Site 099
Hialeah, Florida, United States, 33012
Investigational Site 009
Jacksonville, Florida, United States, 32216
Lauderdale Lakes, Florida, United States, 33319
Miami, Florida, United States, 33165
Orange Park, Florida, United States, 32073
Investigational Site 112
Pensacola, Florida, United States, 32504
Port Saint Lucie, Florida, United States, 34987
Investigational Site 040
Saint Petersburg, Florida, United States, 33709
Investigational Site 114
Saint Petersburg, Florida, United States, 33713
Investigational Site 088
Sarasota, Florida, United States, 34239
Tamarac, Florida, United States, 33321
Tampa, Florida, United States, 33612
West Palm Beach, Florida, United States, 33401
United States, Georgia
Investigational Site 149
Augusta, Georgia, United States, 30912
Investigational Site 529
Decatur, Georgia, United States, 30030
Macon, Georgia, United States, 31201
Investigational Site 010
Savannah, Georgia, United States, 31406
United States, Idaho
Investigational Site 049
Idaho Falls, Idaho, United States, 83494
Investigational Site 543
Pocatello, Idaho, United States, 83201
United States, Illinois
Evanston, Illinois, United States, 60201
Peoria, Illinois, United States, 61602
Peoria, Illinois, United States, 61614
United States, Indiana
Anderson, Indiana, United States, 46011
United States, Iowa
Investigational Site 101
Iowa City, Iowa, United States, 52242
United States, Kansas
Topeka, Kansas, United States, 66606
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Investigational Site 091
Metairie, Louisiana, United States, 70006
Investigational Site 084
New Orleans, Louisiana, United States, 70121
Opelousas, Louisiana, United States, 70570
Investigational Site 077
Shreveport, Louisiana, United States, 71101
United States, Maine
Auburn, Maine, United States, 04210
United States, Maryland
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Investigational Site 002
Boston, Massachusetts, United States, 02215
Investigational Site 035
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Investigational Site 190
Ann Arbor, Michigan, United States, 48106
Investigational Site 175
Detroit, Michigan, United States, 48202
Investigational Site 183
Flint, Michigan, United States, 48504
Grosse Pointe Woods, Michigan, United States, 48236
Kalamazoo, Michigan, United States, 49007
Livonia, Michigan, United States, 48152
Investigational Site 069
Royal Oak, Michigan, United States, 48073
Stevensville, Michigan, United States, 49127
Troy, Michigan, United States, 48098
United States, Montana
Butte, Montana, United States, 59701
United States, New Jersey
Investigational Site 189
Hillsborough, New Jersey, United States, 8844
Investigational Site 044
Neptune, New Jersey, United States, 07753
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Albuquerque, New Mexico, United States, 27103
Albuquerque, New Mexico, United States, 87102
United States, New York
Bronx, New York, United States, 10467
Investigational Site 013
Bronx, New York, United States, 10468
Investigational Site 022
Endwell, New York, United States, 13760
Rochester, New York, United States, 14621
Rochester, New York, United States, 14642
Syracuse, New York, United States, 13210
United States, North Carolina
Investigational Site 146
Asheville, North Carolina, United States, 28805
Cary, North Carolina, United States, 27518
Charlotte, North Carolina, United States, 28209
Hickory, North Carolina, United States, 28602
Raleigh, North Carolina, United States, 27612
Raleigh, North Carolina, United States, 48202
Statesville, North Carolina, United States, 28625
Wilmington, North Carolina, United States, 28401
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Investigational Site 031
Fargo, North Dakota, United States, 58104
Fargo, North Dakota, United States, 58122
United States, Ohio
Investigational Site 523
Canton, Ohio, United States, 44710
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
Investigational Site 129
Cleveland, Ohio, United States, 44109
Cleveland, Ohio, United States, 44118
Investigational Site 003
Columbus, Ohio, United States, 43215
Investigational Site 061
Dayton, Ohio, United States, 45419
Dayton, Ohio, United States, 45428
Kettering, Ohio, United States, 45429
Marion, Ohio, United States, 43302
Investigational Site 095
Middletown, Ohio, United States, 45005
United States, Oregon
Bend, Oregon, United States, 97701
United States, Pennsylvania
Investigational Site 528
Camp Hill, Pennsylvania, United States, 17011
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19140
Pittsburgh, Pennsylvania, United States, 15212
Pittsburgh, Pennsylvania, United States, 15240
Investigational Site 083
Uniontown, Pennsylvania, United States, 15401
West Reading, Pennsylvania, United States, 19611
Investigational Site 020
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Investigational Site 050
Pawtucket, Rhode Island, United States, 02860
Providence, Rhode Island, United States, 02906
Providence, Rhode Island, United States, 02908
United States, South Carolina
Investigational Site 540
Charleston, South Carolina, United States, 29407
Investigational Site 047
Mount Pleasant, South Carolina, United States, 29464
Investigational Site 180
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Investigational Site 086
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Franklin, Tennessee, United States, 37067
Jackson, Tennessee, United States, 38305
Nashville, Tennessee, United States, 37082
Nashville, Tennessee, United States, 37203
United States, Texas
Investigational Site 544
Austin, Texas, United States, 78726
Corpus Christi, Texas, United States, 78413
Investigational Site 006
Dallas, Texas, United States, 75216
Investigational Site 119
Fort Worth, Texas, United States, 76104
Groesbeck, Texas, United States, 76642
Investigational Site 193
San Antonio, Texas, United States, 78229
Tomball, Texas, United States, 77375
United States, Utah
Investigational Site 135
Orem, Utah, United States, 84058
Investigational Site 080
Salt Lake City, Utah, United States, 84124
United States, Virginia
Investigational Site 012
Lynchburg, Virginia, United States, 24501
Williamsburg, Virginia, United States, 23185
Investigational Site 196
Winchester, Virginia, United States, 22601
United States, Washington
Spokane, Washington, United States, 99202
Tacoma, Washington, United States, 98405
United States, Wisconsin
Investigational Site 030
Marshfield, Wisconsin, United States, 54449
Weston, Wisconsin, United States, 54476
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Investigational Site 401
Cairns, Queensland, Australia, 4870
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Investigational Site 404
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Investigational Site 403
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Subiaco, Western Australia, Australia, 6008
Brazil
Salvador, BA, Brazil, 40420-000
Salvado, BA, Brazil, 41253-190
Aparecida de Goiânia, GO, Brazil, 74935-530
Belo Horizonte, MG, Brazil, 30150-221
Belo Horizonte, MG, Brazil, 30190-130
Juiz De For A, MG, Brazil, 36010-570
Recife, PE, Brazil, 52020-010
Curitiba, PR, Brazil, 80810-040
Nova Iguaçu, RJ, Brazil, 26030-380
Rio de Janeiro, RJ, Brazil, 22271-100
Natal, RN, Brazil, 59025-600
Canoas, RS, Brazil, 92425-900
Porto Alegre, RS, Brazil, 90035-003
Santo Andre, SP, Brazil, 09060-650
Campinas, Brazil, 13020431
Canada, British Columbia
New Westminster, British Columbia, Canada, V3L 3W7
Investigational Site 156
Surrey, British Columbia, Canada, V3V 1Z2
Investigational Site 158
Vancouver, British Columbia, Canada, V5Z IM9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A IR9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K 6R8
Investigational Site 163
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
Guelph, Ontario, Canada, N1H 1B1
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Pierrefonds, Quebec, Canada, H9H 4Y6
Investigational Site 152
Québec, Quebec, Canada, G1E 7G9
Investigational Site 151
Sherbrooke, Quebec, Canada, J1H5N4
Investigational Site 161
Trois-Rivières, Quebec, Canada, G8Z 3R9
Colombia
Barranquilla, Alantico, Colombia
Medellin, Antioquia, Colombia
Bogota, Ditrito Capital, Colombia
Bogota, Ditrito, Colombia
Armenia, Quindio, Colombia
Bucaramanga, Santander, Colombia
Floridablanca, Santander, Colombia
Yopal, Colombia
Costa Rica
San José, Costa Rica, 250-1000
Denmark
Investigational Site 215
Aarhus, Denmark, 8200
Dominican Republic
Investigational Site 347
Santo Domingo, Dominican Republic
Finland
Espoo, Finland, FIN-02100
Helsinki, Finland, FIN-00100
Helsinki, Finland, FIN-00930
Investigational Site 203
Järvenpää, Finland, FIN-04400
Kokkola, Finland, 67100
Oulu, Finland, FIN-90220
Pori, Finland, 28100
Seinajoki, Finland, 60100
Investigational Site 201
Tampere, Finland, FIN-33100
Investigational Site 202
Turku, Finland, FIN-20520
Vantaa, Finland, FIN-01300
France
Investigational Site 230
Dijon, France, 21079
Lille, France, 49100
Limoges, France, 87042
Lyon, France, 69004
Montpellier, France, 34295
Orleans, France, 45100
Investigational Site 221
Paris, France, 75014
Investigational Site 229
Pringy, France, 21079
Saint Etienne, France, 42055
Investigational Site 223
St Priest en Jarez, France, 42270
Tourcoing, France, 59208
Investigational Site 232
Tours, France, 37044
Germany
Munich, Bavaria, Germany, 81675
Investigational Site 242
Wurzburg, Bayern, Germany, 97074
Investigational Site 244
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
Investigational Site 247
Hamburg, Germany, 20359
Investigational Site 245
Hamburg, Germany, 22143
Leipzig, Germany, 97074
Guatemala
Guatemala, Guatemala, 1001
Japan
Investigational Site 450
Aichi, Japan, 491-8551
Investigational Site 468
Chiba, Japan, 278-0004
Investigational Site 467
Fukui, Japan, 910-0067
Investigational Site 464
Fukuoka, Japan, 800-0344
Investigational Site 465
Fukuoka, Japan, 814-8525
Investigational Site 466
Fukuoka, Japan, 838-0069
Investigational Site 457
Gumma, Japan, 371-0014
Investigational Site 455
Hyōgo, Japan, 666-0125
Investigational Site 453
Ibaraki, Japan, 300-0028
Investigational Site 460
Kyoto, Japan, 611-0041
Investigational Site 454
Kyoto, Japan, 613-0034
Investigational Site 456
Nagano, Japan, 382-0091
Investigational Site 452
Nagano, Japan, 390-8601
Investigational Site 458
Nagano, Japan, 392-8510
Investigational Site 469
Okinawa, Japan, 904-2293
Investigational Site 459
Saitama, Japan, 348-0044
Investigational Site 467
Shimonoseki, Japan, 750-8520
Investigational Site 451
Tokyo, Japan, 171-0014
Investigational Site 463
Yamaguchi, Japan, 750-8520
Investigational Site 461
Ōsaka, Japan, 596-8522
Korea, Republic of
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Investigational Site 407
Wŏnju, Gangwon-do, Korea, Republic of, 26427
Investigational Site 413
Ansan, Gyeonggi-do, Korea, Republic of, 15355
Daegu, Jung-Gu, Korea, Republic of, 700-721
Investigational Site 427
Incheon, Namdong-gu, Korea, Republic of, 22332
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
Investigational Site 446
Busan, Korea, Republic of, 49201
Chungcheongbuk-do, Korea, Republic of, 361-711
Investigational Site 439
Gyeonggi-do, Korea, Republic of, 16247
Gyeonggi-do, Korea, Republic of, 443-380
Investigational Site 412
Incheon, Korea, Republic of, 21565
Investigational Site 409
Seoul, Korea, Republic of, 2841
Investigational Site 408
Seoul, Korea, Republic of, 3722
Investigational Site 415
Seoul, Korea, Republic of, 5355
Investigational Site 418
Seoul, Korea, Republic of, 5505
Investigational Site 411
Seoul, Korea, Republic of, 6351
Investigational Site 437
Seoul, Korea, Republic of, 7441
Investigational Site 438
Seoul, Korea, Republic of, 8308
Mexico
Aguascalientes, AGS, Mexico, 20230
Tijuana, Baja California, Mexico, 22320
Investigational Site 325
Mexico City, D.f., Mexico, 14000
Investigational Site 329
Mexico City, D.f., Mexico, 14080
Investigational Site 352
Ecatepec, Estado De Mexico, Mexico, 55076
Investigational Site 324
Guadalajara, Jalisco, Mexico, 44280
Investigational Site 351
Cuernavaca, Morelos, Mexico, 62290
Monterrey, NL, Mexico, 64460
San Luis Potosi, SLP, Mexico, 78240
Investigational Site 363
Ciudad Victoria, Tamaulipas, Mexico
Investigational Site 326
Durango, Mexico, 34000
Morelos, Mexico
San Luis Potosi, Mexico, 78240
Panama
Investigational Site 354
Panama City, Panama
Peru
Investigational Site 364
Trujillo, La Libertad, Peru, 130101
Cercado De Lima, Lima, Peru
Investigational Site 332
Jesus Maria, Lima, Peru, lima 11
Investigational Site 334
San Martín de Porres, Lima, Peru, lima 31
Surquillo, Lima, Peru
Investigational Site 356
Lima, Peru, callao 2
Investigational Site 355
Lima, Peru, lima 1
Lima, Peru
Investigational Site 365
Piura, Peru, 200101
Philippines
Alabang, Philippines, 1770
Dasmarinas, Philippines, 4114
Manila, Philippines, 1000
Manila, Philippines, 1004
Pasig City, Philippines, 1600
Quezon City, Philippines, 1100
Quezon City, Philippines, 1101
Poland
Investigational Site 284
Bydgoszcz, Poland, 85-863
Investigational Site 283
Nowy, Poland, 09-505
Puerto Rico
Investigational Site 171
Bayamon, Puerto Rico, 00960
Bayamon, Puerto Rico, 00961
Singapore
Singapore, Singapore, 119074
Investigational Site 419
Singapore, Singapore, 119228
Singapore, Singapore, 169608
Investigational Site 428
Singapore, Singapore, 308433
Investigational Site 445
Singapore, Singapore, 768828
Spain
Investigational Site 294
Cordoba, Spain, 14004
Investigational Site 293
Santander, Spain, 39008
Investigational Site 292
Terrassa, Spain, 08221
Investigational Site 295
Vigo, Spain, 36312
Sweden
Göthenburg, SWE, Sweden, 41685
Stockholm, Sweden, 11157
Umea, Sweden, 90185
Taiwan
Kaohsiung, Taiwan, 813
Investigational Site 426
New Taipei City, Taiwan, 22056
New Taipei City, Taiwan, 23156
Investigational Site 429
Taichung City, Taiwan, 40201
Investigational Site 421
Tainan, Taiwan, 71004
Investigational Site 425
Taipei, Taiwan, 10002
Tiachung, Taiwan, 404
Thailand
Investigational Site 443
Bangkok, Thailand, 10330
Investigational Site 442
Bangkok, Thailand, 10400
Investigational Site 441
Khon Kaen, Thailand, 40002
United Kingdom
Investigational Site 276
Blackpool, United Kingdom, FY3 7EN
Investigational Site 277
Coventry, United Kingdom, CV2 2DX
Harrow, United Kingdom, HA1 3UJ
Lancashire, United Kingdom, FY3 8NR
Investigational Site 281
Leeds, United Kingdom, LS9 7TF
Liverpool, United Kingdom, L78XP
Investigational Site 271
London, United Kingdom, SW17 0RE
Manchester, United Kingdom, M8 5RB
Middlesex, United Kingdom, HA1 3UJ
North Shields, United Kingdom, NE29 8NH
Investigational Site 275
Penzance, United Kingdom, TR19 7HX
Stoke on Trent, United Kingdom, SR53SY
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 )
First Submitted: June 20, 2013
First Posted: June 27, 2013
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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, 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