Study Stopped
The Independent Data Monitoring Committee (IDMC) concluded that the probability that the study will meet its primary objective is low.
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)
3 other identifiers
interventional
9,302
25 countries
334
Brief Summary
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at 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 participants 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 at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety:
- To describe the safety profile of all participants who received at least 1 injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
Longer than P75 for phase_3
334 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedStudy Start
First participant enrolled
July 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2018
CompletedResults Posted
Study results publicly available
July 5, 2019
CompletedMarch 28, 2022
March 1, 2022
4.9 years
June 20, 2013
June 11, 2019
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases
Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Up to 3 years post injection 1
Secondary Outcomes (10)
Number of Participants With Severe PCR-Confirmed Primary CDI Cases
Up to 3 years post injection 1
Number of Participants With Loose Stool Episodes
Up to 3 years post injection 1
Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
Up to 3 years post injection 1
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Day 60
- +5 more secondary outcomes
Study Arms (2)
C. difficile Vaccine Group
EXPERIMENTALParticipants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Placebo Group
PLACEBO COMPARATORParticipants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent form had been signed and dated.
- Attended all scheduled visits and complied with all trial procedures.
- Covered by health insurance (if required).
- Must fulfill at least 1 of the following criteria
- Risk Stratum 1:
- Had at least 2 hospital stays, each lasting at least \>= 24 hours, in the 12 months before enrollment, and
- Had received systemic (not topical) antibiotics in the 12 months before enrollment, or
- Risk Stratum 2:
- Was anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay was 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.
You may not qualify if:
- Participant was 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 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (335)
Unknown Facility
Huntsville, Alabama, 35803, United States
Investigational Site 104
Mobile, Alabama, 36608, United States
Unknown Facility
Flagstaff, Arizona, 86001, United States
Investigational Site 194
Phoenix, Arizona, 85018, United States
Investigational Site 503
Surprise, Arizona, 85374, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Bakersfield, California, 93301, United States
Unknown Facility
Banning, California, 92220, United States
Unknown Facility
Garden Grove, California, 92844, United States
Unknown Facility
La Mesa, California, 91942, United States
Investigational Site 534
Los Angeles, California, 90022, United States
Investigational Site 051
Los Angeles, California, 90027, United States
Unknown Facility
Modesto, California, 95350, United States
Unknown Facility
Redding, California, 96001, United States
Unknown Facility
Sacramento, California, 95817, United States
Investigational Site 504
Simi Valley, California, 93065, United States
Investigational Site 057
Stanford, California, 94305, United States
Investigational Site 176
Upland, California, 91786, United States
Unknown Facility
Ventura, California, 93003, United States
Investigational Site 546
Wheat Ridge, Colorado, 90033, United States
Unknown Facility
Bristol, Connecticut, 06010, United States
Unknown Facility
Danbury, Connecticut, 06810, United States
Investigational Site 143
Bradenton, Florida, 34209, United States
Investigational Site 187
Brandon, Florida, 33511, United States
Investigational Site 075
Clearwater, Florida, 33756, United States
Investigational Site 517
Clearwater, Florida, 33765, United States
Investigational Site 055
Crystal River, Florida, 34429, United States
Unknown Facility
DeLand, Florida, 32720, United States
Investigational Site 506
Gainesville, Florida, 32607, United States
Investigational Site 099
Hialeah, Florida, 33012, United States
Investigational Site 009
Jacksonville, Florida, 32216, United States
Unknown Facility
Lauderdale Lakes, Florida, 33319, United States
Unknown Facility
Miami, Florida, 33165, United States
Unknown Facility
Orange Park, Florida, 32073, United States
Investigational Site 112
Pensacola, Florida, 32504, United States
Unknown Facility
Port Saint Lucie, Florida, 34987, United States
Investigational Site 088
Sarasota, Florida, 34239, United States
Investigational Site 040
St. Petersburg, Florida, 33709, United States
Investigational Site 114
St. Petersburg, Florida, 33713, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Investigational Site 149
Augusta, Georgia, 30912, United States
Investigational Site 529
Decatur, Georgia, 30030, United States
Unknown Facility
Macon, Georgia, 31201, United States
Investigational Site 010
Savannah, Georgia, 31406, United States
Investigational Site 049
Idaho Falls, Idaho, 83494, United States
Investigational Site 543
Pocatello, Idaho, 83201, United States
Unknown Facility
Evanston, Illinois, 60201, United States
Unknown Facility
Peoria, Illinois, 61602, United States
Unknown Facility
Peoria, Illinois, 61614, United States
Unknown Facility
Anderson, Indiana, 46011, United States
Investigational Site 101
Iowa City, Iowa, 52242, United States
Unknown Facility
Topeka, Kansas, 66606, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Investigational Site 091
Metairie, Louisiana, 70006, United States
Investigational Site 084
New Orleans, Louisiana, 70121, United States
Unknown Facility
Opelousas, Louisiana, 70570, United States
Investigational Site 077
Shreveport, Louisiana, 71101, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Baltimore, Maryland, 21224, United States
Investigational Site 002
Boston, Massachusetts, 02215, United States
Investigational Site 035
West Roxbury, Massachusetts, 02132, United States
Investigational Site 190
Ann Arbor, Michigan, 48106, United States
Investigational Site 175
Detroit, Michigan, 48202, United States
Investigational Site 183
Flint, Michigan, 48504, United States
Unknown Facility
Grosse Pointe Woods, Michigan, 48236, United States
Unknown Facility
Kalamazoo, Michigan, 49007, United States
Unknown Facility
Livonia, Michigan, 48152, United States
Investigational Site 069
Royal Oak, Michigan, 48073, United States
Unknown Facility
Stevensville, Michigan, 49127, United States
Unknown Facility
Troy, Michigan, 48098, United States
Unknown Facility
Butte, Montana, 59701, United States
Investigational Site 189
Hillsborough, New Jersey, 8844, United States
Investigational Site 044
Neptune City, New Jersey, 07753, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Albuquerque, New Mexico, 27103, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Investigational Site 022
Endwell, New York, 13760, United States
Unknown Facility
Rochester, New York, 14621, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
The Bronx, New York, 10467, United States
Investigational Site 013
The Bronx, New York, 10468, United States
Investigational Site 146
Asheville, North Carolina, 28805, United States
Unknown Facility
Cary, North Carolina, 27518, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Hickory, North Carolina, 28602, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Raleigh, North Carolina, 48202, United States
Unknown Facility
Statesville, North Carolina, 28625, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Investigational Site 031
Fargo, North Dakota, 58104, United States
Unknown Facility
Fargo, North Dakota, 58122, United States
Investigational Site 523
Canton, Ohio, 44710, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Investigational Site 129
Cleveland, Ohio, 44109, United States
Unknown Facility
Cleveland, Ohio, 44118, United States
Investigational Site 003
Columbus, Ohio, 43215, United States
Investigational Site 061
Dayton, Ohio, 45419, United States
Unknown Facility
Dayton, Ohio, 45428, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Marion, Ohio, 43302, United States
Investigational Site 095
Middletown, Ohio, 45005, United States
Unknown Facility
Bend, Oregon, 97701, United States
Investigational Site 528
Camp Hill, Pennsylvania, 17011, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15212, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15240, United States
Investigational Site 083
Uniontown, Pennsylvania, 15401, United States
Unknown Facility
West Reading, Pennsylvania, 19611, United States
Investigational Site 020
Wilkes-Barre, Pennsylvania, 18711, United States
Investigational Site 050
Pawtucket, Rhode Island, 02860, United States
Unknown Facility
Providence, Rhode Island, 02906, United States
Unknown Facility
Providence, Rhode Island, 02908, United States
Investigational Site 540
Charleston, South Carolina, 29407, United States
Investigational Site 047
Mt. Pleasant, South Carolina, 29464, United States
Investigational Site 180
Spartanburg, South Carolina, 29303, United States
Investigational Site 086
Rapid City, South Dakota, 57701, United States
Unknown Facility
Franklin, Tennessee, 37067, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Nashville, Tennessee, 37082, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Investigational Site 544
Austin, Texas, 78726, United States
Unknown Facility
Corpus Christi, Texas, 78413, United States
Investigational Site 006
Dallas, Texas, 75216, United States
Investigational Site 119
Fort Worth, Texas, 76104, United States
Unknown Facility
Groesbeck, Texas, 76642, United States
Investigational Site 193
San Antonio, Texas, 78229, United States
Unknown Facility
Tomball, Texas, 77375, United States
Investigational Site 135
Orem, Utah, 84058, United States
Investigational Site 080
Salt Lake City, Utah, 84124, United States
Investigational Site 012
Lynchburg, Virginia, 24501, United States
Unknown Facility
Williamsburg, Virginia, 23185, United States
Investigational Site 196
Winchester, Virginia, 22601, United States
Unknown Facility
Spokane, Washington, 99202, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Investigational Site 030
Marshfield, Wisconsin, 54449, United States
Unknown Facility
Weston, Wisconsin, 54476, United States
Unknown Facility
Westmead, New South Wales, 2145, Australia
Investigational Site 401
Cairns, Queensland, 4870, Australia
Unknown Facility
Woolloongabba, Queensland, 4102, Australia
Investigational Site 404
Bedford Park, South Australia, 5042, Australia
Investigational Site 403
Clayton, Victoria, 3168, Australia
Unknown Facility
Nedlands, Western Australia, 6009, Australia
Unknown Facility
Subiaco, Western Australia, 6008, Australia
Unknown Facility
Salvador, Estado de Bahia, 40420-000, Brazil
Unknown Facility
Salvador, Estado de Bahia, 41253-190, Brazil
Unknown Facility
Aparecida de Goiânia, Goiás, 74935-530, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 30190-130, Brazil
Unknown Facility
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Unknown Facility
Curitiba, Paraná, 80810-040, Brazil
Unknown Facility
Recife, Pernambuco, 52020-010, Brazil
Unknown Facility
Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Unknown Facility
Natal, Rio Grande do Norte, 59025-600, Brazil
Unknown Facility
Canoas, Rio Grande do Sul, 92425-900, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Unknown Facility
Santo André, São Paulo, 09060-650, Brazil
Unknown Facility
Campinas, 13020431, Brazil
Unknown Facility
New Westminster, British Columbia, V3L 3W7, Canada
Investigational Site 156
Surrey, British Columbia, V3V 1Z2, Canada
Investigational Site 158
Vancouver, British Columbia, V5Z IM9, Canada
Unknown Facility
Winnipeg, Manitoba, R3A IR9, Canada
Unknown Facility
Halifax, Nova Scotia, B3K 6R8, Canada
Investigational Site 163
Truro, Nova Scotia, B2N 1L2, Canada
Unknown Facility
Guelph, Ontario, N1H 1B1, Canada
Unknown Facility
Toronto, Ontario, M5G 1X5, Canada
Unknown Facility
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Pierrefonds, Quebec, H9H 4Y6, Canada
Investigational Site 152
Québec, Quebec, G1E 7G9, Canada
Investigational Site 151
Sherbrooke, Quebec, J1H5N4, Canada
Investigational Site 161
Trois-Rivières, Quebec, G8Z 3R9, Canada
Unknown Facility
Barranquilla, Alantico, Colombia
Unknown Facility
Medellín, Antioquia, Colombia
Unknown Facility
Bogotá, Ditrito Capital, Colombia
Unknown Facility
Bogotá, Ditrito, Colombia
Unknown Facility
Armenia, Quindío Department, Colombia
Unknown Facility
Bucaramanga, Santander Department, Colombia
Unknown Facility
Floridablanca, Santander Department, Colombia
Unknown Facility
Yopal, Colombia
Unknown Facility
San José, 250-1000, Costa Rica
Investigational Site 215
Aarhus, 8200, Denmark
Investigational Site 347
Santo Domingo, Dominican Republic
Unknown Facility
Espoo, FIN-02100, Finland
Unknown Facility
Helsinki, FIN-00100, Finland
Unknown Facility
Helsinki, FIN-00930, Finland
Investigational Site 203
Jarvenpaa, FIN-04400, Finland
Unknown Facility
Kokkola, 67100, Finland
Unknown Facility
Oulu, FIN-90220, Finland
Unknown Facility
Pori, 28100, Finland
Unknown Facility
Seinäjoki, 60100, Finland
Investigational Site 201
Tampere, FIN-33100, Finland
Investigational Site 202
Turku, FIN-20520, Finland
Unknown Facility
Vantaa, FIN-01300, Finland
Investigational Site 230
Dijon, 21079, France
Unknown Facility
Lille, 49100, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lyon, 69004, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Orléans, 45100, France
Investigational Site 221
Paris, 75014, France
Investigational Site 229
Pringy, 21079, France
Unknown Facility
Saint-Etienne, 42055, France
Investigational Site 223
Saint-Priest-en-Jarez, 42270, France
Unknown Facility
Tourcoing, 59208, France
Investigational Site 232
Tours, 37044, France
Investigational Site 244
Deggingen, Baden-Wurttemberg, 73326, Germany
Unknown Facility
Munich, Bavaria, 81675, Germany
Investigational Site 242
Würzburg, Bavaria, 97074, Germany
Unknown Facility
Cologne, North Rhine-Westphalia, 50937, Germany
Unknown Facility
Leipzig, Saxony, 04109, Germany
Unknown Facility
Jena, Thuringia, 07747, Germany
Unknown Facility
Berlin, 10629, Germany
Unknown Facility
Berlin, 13347, Germany
Unknown Facility
Essen, 45355, Germany
Unknown Facility
Goch, 47574, Germany
Investigational Site 247
Hamburg, 20359, Germany
Investigational Site 245
Hamburg, 22143, Germany
Unknown Facility
Leipzig, 97074, Germany
Unknown Facility
Guatemala City, 1001, Guatemala
Investigational Site 450
Aichi, 491-8551, Japan
Investigational Site 468
Chiba, 278-0004, Japan
Investigational Site 467
Fukui, 910-0067, Japan
Investigational Site 464
Fukuoka, 800-0344, Japan
Investigational Site 465
Fukuoka, 814-8525, Japan
Investigational Site 466
Fukuoka, 838-0069, Japan
Investigational Site 457
Gunma, 371-0014, Japan
Investigational Site 455
Hyōgo, 666-0125, Japan
Investigational Site 453
Ibaraki, 300-0028, Japan
Investigational Site 460
Kyoto, 611-0041, Japan
Investigational Site 454
Kyoto, 613-0034, Japan
Investigational Site 456
Nagano, 382-0091, Japan
Investigational Site 452
Nagano, 390-8601, Japan
Investigational Site 458
Nagano, 392-8510, Japan
Investigational Site 469
Okinawa, 904-2293, Japan
Investigational Site 461
Ōsaka, 596-8522, Japan
Investigational Site 459
Saitama, 348-0044, Japan
Investigational Site 467
Shimonoseki, 750-8520, Japan
Investigational Site 451
Tokyo, 171-0014, Japan
Investigational Site 463
Yamaguchi, 750-8520, Japan
Unknown Facility
Aguascalientes, Aguascalientes, 20230, Mexico
Investigational Site 325
Mexico City, D.F., 14000, Mexico
Investigational Site 329
Mexico City, D.F., 14080, Mexico
Unknown Facility
Tijuana, Estado de Baja California, 22320, Mexico
Investigational Site 324
Guadalajara, Jalisco, 44280, Mexico
Investigational Site 351
Cuernavaca, Morelos, 62290, Mexico
Unknown Facility
Monterrey, Nuevo León, 64460, Mexico
Unknown Facility
San Luis Potosí City, San Luis Potosí, 78240, Mexico
Investigational Site 352
Ecatepec de Morelos, State of Mexico, 55076, Mexico
Investigational Site 363
Ciudad Victoria, Tamaulipas, Mexico
Investigational Site 326
Durango, 34000, Mexico
Unknown Facility
Morelos, Mexico
Unknown Facility
San Luis Potosí City, 78240, Mexico
Investigational Site 354
Panama City, Panama
Investigational Site 364
Trujillo, La Libertad, 130101, Peru
Investigational Site 332
Jesus Maria, Lima region, lima 11, Peru
Unknown Facility
Lima Cercado, Lima region, Peru
Investigational Site 334
San Martín de Porres, Lima region, lima 31, Peru
Unknown Facility
Surquillo, Lima region, Peru
Investigational Site 356
Lima, callao 2, Peru
Investigational Site 355
Lima, lima 1, Peru
Unknown Facility
Lima, Peru
Investigational Site 365
Piura, 200101, Peru
Unknown Facility
Alabang, 1770, Philippines
Unknown Facility
Dasmariñas, 4114, Philippines
Unknown Facility
Manila, 1000, Philippines
Unknown Facility
Manila, 1004, Philippines
Unknown Facility
Pasig, 1600, Philippines
Unknown Facility
Quezon City, 1100, Philippines
Unknown Facility
Quezon City, 1101, Philippines
Investigational Site 284
Bydgoszcz, 85-863, Poland
Investigational Site 283
Nowy Duninów, 09-505, Poland
Investigational Site 171
Bayamón, PR, 00960, Puerto Rico
Unknown Facility
Bayamón, 00961, Puerto Rico
Unknown Facility
Singapore, 119074, Singapore
Investigational Site 419
Singapore, 119228, Singapore
Unknown Facility
Singapore, 169608, Singapore
Investigational Site 428
Singapore, 308433, Singapore
Investigational Site 445
Singapore, 768828, Singapore
Unknown Facility
Seoul, Gangnam-gu, 135-710, South Korea
Investigational Site 407
Wŏnju, Gangwon-do, 26427, South Korea
Investigational Site 413
Ansan, Gyeonggi-do, 15355, South Korea
Unknown Facility
Daegu, Jung-Gu, 700-721, South Korea
Investigational Site 427
Incheon, Namdong-gu, 22332, South Korea
Unknown Facility
Seoul, Seocho-gu, 137-701, South Korea
Unknown Facility
Seoul, Seodaemun-gu, 120-752, South Korea
Unknown Facility
Seoul, Seongbuk-gu, 136-705, South Korea
Unknown Facility
Seoul, Seongdong-gu, 132-792, South Korea
Unknown Facility
Seoul, Songpa-gu, 138-736, South Korea
Investigational Site 446
Busan, 49201, South Korea
Unknown Facility
Cheongju-si, 361-711, South Korea
Investigational Site 439
Gyeonggi-do, 16247, South Korea
Unknown Facility
Gyeonggi-do, 443-380, South Korea
Investigational Site 412
Incheon, 21565, South Korea
Investigational Site 409
Seoul, 2841, South Korea
Investigational Site 408
Seoul, 3722, South Korea
Investigational Site 415
Seoul, 5355, South Korea
Investigational Site 418
Seoul, 5505, South Korea
Investigational Site 411
Seoul, 6351, South Korea
Investigational Site 437
Seoul, 7441, South Korea
Investigational Site 438
Seoul, 8308, South Korea
Investigational Site 294
Córdoba, 14004, Spain
Investigational Site 293
Santander, 39008, Spain
Investigational Site 292
Terrassa, 08221, Spain
Investigational Site 295
Vigo, 36312, Spain
Unknown Facility
Göthenburg, SWE, 41685, Sweden
Unknown Facility
Stockholm, 11157, Sweden
Unknown Facility
Umeå, 90185, Sweden
Unknown Facility
Kaohsiung City, 813, Taiwan
Investigational Site 426
New Taipei City, 22056, Taiwan
Unknown Facility
New Taipei City, 23156, Taiwan
Investigational Site 429
Taichung, 40201, Taiwan
Investigational Site 421
Tainan, 71004, Taiwan
Investigational Site 425
Taipei, 10002, Taiwan
Unknown Facility
Tiachung, 404, Taiwan
Investigational Site 443
Bangkok, 10330, Thailand
Investigational Site 442
Bangkok, 10400, Thailand
Investigational Site 441
Khon Kaen, 40002, Thailand
Investigational Site 276
Blackpool, FY3 7EN, United Kingdom
Unknown Facility
Blackpool, FY3 8NR, United Kingdom
Investigational Site 277
Coventry, CV2 2DX, United Kingdom
Unknown Facility
Harrow, HA1 3UJ, United Kingdom
Investigational Site 281
Leeds, LS9 7TF, United Kingdom
Unknown Facility
Liverpool, L78XP, United Kingdom
Investigational Site 271
London, SW17 0RE, United Kingdom
Unknown Facility
Manchester, M8 5RB, United Kingdom
Unknown Facility
Middlesex, HA1 3UJ, United Kingdom
Unknown Facility
North Shields, NE29 8NH, United Kingdom
Investigational Site 275
Penzance, TR19 7HX, United Kingdom
Unknown Facility
Stoke-on-Trent, SR53SY, United Kingdom
Related Publications (1)
de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhaes Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2021 Feb;21(2):252-262. doi: 10.1016/S1473-3099(20)30331-5. Epub 2020 Sep 15.
PMID: 32946836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2013
First Posted
June 27, 2013
Study Start
July 30, 2013
Primary Completion
June 12, 2018
Study Completion
June 12, 2018
Last Updated
March 28, 2022
Results First Posted
July 5, 2019
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org