AzTrials
AzTrials

Clostridium Difficile InfectionPhase 3NCT01887912

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

A Phase 3 study testing C. difficile Toxoid Vaccine in people with Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 335 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Clostridium Difficile Infection
What is being tested?
C. difficile Toxoid Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,302 participants
Where
335 sitesin 26 countries
Study dates
30 Jul 2013to 12 Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged >= 50 years on the day of inclusion
  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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 degree Celsius [>= 100.4°Fahrenheit]). A prospective participant 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.

Trial locations and contacts

335 sites in 26 countries.

335 sites in 26 countries

United States142 sites

  • Study site

    Albuquerque, New Mexico, 27103

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Anderson, Indiana, 46011

  • Investigational Site 190

    Ann Arbor, Michigan, 48106

  • Investigational Site 146

    Asheville, North Carolina, 28805

  • Study site

    Auburn, Maine, 04210

  • Investigational Site 149

    Augusta, Georgia, 30912

  • Investigational Site 544

    Austin, Texas, 78726

  • Study site

    Bakersfield, California, 93301

  • Study site

    Baltimore, Maryland, 21224

  • Study site

    Banning, California, 92220

  • Study site

    Bend, Oregon, 97701

  • Investigational Site 002

    Boston, Massachusetts, 02215

  • Investigational Site 143

    Bradenton, Florida, 34209

  • Investigational Site 187

    Brandon, Florida, 33511

  • Study site

    Bristol, Connecticut, 06010

  • Study site

    Butte, Montana, 59701

  • Investigational Site 528

    Camp Hill, Pennsylvania, 17011

  • Investigational Site 523

    Canton, Ohio, 44710

  • Study site

    Cary, North Carolina, 27518

  • Investigational Site 540

    Charleston, South Carolina, 29407

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Cincinnati, Ohio, 45219

  • Investigational Site 075

    Clearwater, Florida, 33756

  • Investigational Site 517

    Clearwater, Florida, 33765

  • Study site

    Cleveland, Ohio, 44106

  • Investigational Site 129

    Cleveland, Ohio, 44109

  • Study site

    Cleveland, Ohio, 44118

  • Investigational Site 003

    Columbus, Ohio, 43215

  • Study site

    Corpus Christi, Texas, 78413

  • Investigational Site 055

    Crystal River, Florida, 34429

  • Investigational Site 006

    Dallas, Texas, 75216

  • Study site

    Danbury, Connecticut, 06810

  • Investigational Site 061

    Dayton, Ohio, 45419

  • Study site

    Dayton, Ohio, 45428

  • Investigational Site 529

    Decatur, Georgia, 30030

  • Study site

    DeLand, Florida, 32720

  • Investigational Site 175

    Detroit, Michigan, 48202

  • Investigational Site 022

    Endwell, New York, 13760

  • Study site

    Evanston, Illinois, 60201

  • Investigational Site 031

    Fargo, North Dakota, 58104

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Flagstaff, Arizona, 86001

  • Investigational Site 183

    Flint, Michigan, 48504

  • Investigational Site 119

    Fort Worth, Texas, 76104

  • Study site

    Franklin, Tennessee, 37067

  • Investigational Site 506

    Gainesville, Florida, 32607

  • Study site

    Garden Grove, California, 92844

  • Study site

    Groesbeck, Texas, 76642

  • Study site

    Grosse Pointe Woods, Michigan, 48236

  • Study site

    Hershey, Pennsylvania, 17033

  • Investigational Site 099

    Hialeah, Florida, 33012

  • Study site

    Hickory, North Carolina, 28602

  • Investigational Site 189

    Hillsborough, New Jersey, 8844

  • Study site

    Huntsville, Alabama, 35803

  • Investigational Site 049

    Idaho Falls, Idaho, 83494

  • Investigational Site 101

    Iowa City, Iowa, 52242

  • Study site

    Jackson, Tennessee, 38305

  • Investigational Site 009

    Jacksonville, Florida, 32216

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Kettering, Ohio, 45429

  • Study site

    La Mesa, California, 91942

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Livonia, Michigan, 48152

  • Investigational Site 534

    Los Angeles, California, 90022

  • Investigational Site 051

    Los Angeles, California, 90027

  • Study site

    Louisville, Kentucky, 40202

  • Investigational Site 012

    Lynchburg, Virginia, 24501

  • Study site

    Macon, Georgia, 31201

  • Study site

    Marion, Ohio, 43302

  • Investigational Site 030

    Marshfield, Wisconsin, 54449

  • Investigational Site 091

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33165

  • Investigational Site 095

    Middletown, Ohio, 45005

  • Investigational Site 104

    Mobile, Alabama, 36608

  • Study site

    Modesto, California, 95350

  • Investigational Site 047

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Nashville, Tennessee, 37082

  • Study site

    Nashville, Tennessee, 37203

  • Investigational Site 044

    Neptune City, New Jersey, 07753

  • Investigational Site 084

    New Orleans, Louisiana, 70121

  • Study site

    Opelousas, Louisiana, 70570

  • Study site

    Orange Park, Florida, 32073

  • Investigational Site 135

    Orem, Utah, 84058

  • Investigational Site 050

    Pawtucket, Rhode Island, 02860

  • Investigational Site 112

    Pensacola, Florida, 32504

  • Study site

    Peoria, Illinois, 61602

  • Study site

    Peoria, Illinois, 61614

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Investigational Site 194

    Phoenix, Arizona, 85018

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Pittsburgh, Pennsylvania, 15240

  • Investigational Site 543

    Pocatello, Idaho, 83201

  • Study site

    Port Saint Lucie, Florida, 34987

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Providence, Rhode Island, 02908

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Raleigh, North Carolina, 48202

  • Investigational Site 086

    Rapid City, South Dakota, 57701

  • Study site

    Redding, California, 96001

  • Study site

    Rochester, New York, 14621

  • Study site

    Rochester, New York, 14642

  • Investigational Site 069

    Royal Oak, Michigan, 48073

  • Study site

    Sacramento, California, 95817

  • Investigational Site 080

    Salt Lake City, Utah, 84124

  • Investigational Site 193

    San Antonio, Texas, 78229

  • Investigational Site 088

    Sarasota, Florida, 34239

  • Investigational Site 010

    Savannah, Georgia, 31406

  • Investigational Site 077

    Shreveport, Louisiana, 71101

  • Investigational Site 504

    Simi Valley, California, 93065

  • Investigational Site 180

    Spartanburg, South Carolina, 29303

  • Study site

    Spokane, Washington, 99202

  • Investigational Site 040

    St. Petersburg, Florida, 33709

  • Investigational Site 114

    St. Petersburg, Florida, 33713

  • Investigational Site 057

    Stanford, California, 94305

  • Study site

    Statesville, North Carolina, 28625

  • Study site

    Stevensville, Michigan, 49127

  • Investigational Site 503

    Surprise, Arizona, 85374

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tamarac, Florida, 33321

  • Study site

    Tampa, Florida, 33612

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    The Bronx, New York, 10467

  • Investigational Site 013

    The Bronx, New York, 10468

  • Study site

    Tomball, Texas, 77375

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Troy, Michigan, 48098

  • Investigational Site 083

    Uniontown, Pennsylvania, 15401

  • Investigational Site 176

    Upland, California, 91786

  • Study site

    Ventura, California, 93003

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    West Reading, Pennsylvania, 19611

  • Investigational Site 035

    West Roxbury, Massachusetts, 02132

  • Study site

    Weston, Wisconsin, 54476

  • Investigational Site 546

    Wheat Ridge, Colorado, 90033

  • Investigational Site 020

    Wilkes-Barre, Pennsylvania, 18711

  • Study site

    Williamsburg, Virginia, 23185

  • Study site

    Wilmington, North Carolina, 28401

  • Investigational Site 196

    Winchester, Virginia, 22601

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

South Korea22 sites

  • Investigational Site 413

    Ansan, Gyeonggi-do, 15355

  • Investigational Site 446

    Busan, 49201

  • Study site

    Cheongju-si, 361-711

  • Study site

    Daegu, Jung-Gu, 700-721

  • Investigational Site 439

    Gyeonggi-do, 16247

  • Study site

    Gyeonggi-do, 443-380

  • Investigational Site 427

    Incheon, Namdong-gu, 22332

  • Investigational Site 412

    Incheon, 21565

  • Study site

    Seoul, Gangnam-gu, 135-710

  • Study site

    Seoul, Seocho-gu, 137-701

  • Study site

    Seoul, Seodaemun-gu, 120-752

  • Study site

    Seoul, Seongbuk-gu, 136-705

  • Study site

    Seoul, Seongdong-gu, 132-792

  • Study site

    Seoul, Songpa-gu, 138-736

  • Investigational Site 409

    Seoul, 2841

  • Investigational Site 408

    Seoul, 3722

  • Investigational Site 415

    Seoul, 5355

  • Investigational Site 418

    Seoul, 5505

  • Investigational Site 411

    Seoul, 6351

  • Investigational Site 437

    Seoul, 7441

  • Investigational Site 438

    Seoul, 8308

  • Investigational Site 407

    Wŏnju, Gangwon-do, 26427

Other trials in South Korea

Japan20 sites

  • Investigational Site 450

    Aichi, 491-8551

  • Investigational Site 468

    Chiba, 278-0004

  • Investigational Site 467

    Fukui, 910-0067

  • Investigational Site 464

    Fukuoka, 800-0344

  • Investigational Site 465

    Fukuoka, 814-8525

  • Investigational Site 466

    Fukuoka, 838-0069

  • Investigational Site 457

    Gunma, 371-0014

  • Investigational Site 455

    Hyōgo, 666-0125

  • Investigational Site 453

    Ibaraki, 300-0028

  • Investigational Site 460

    Kyoto, 611-0041

  • Investigational Site 454

    Kyoto, 613-0034

  • Investigational Site 456

    Nagano, 382-0091

  • Investigational Site 452

    Nagano, 390-8601

  • Investigational Site 458

    Nagano, 392-8510

  • Investigational Site 469

    Okinawa, 904-2293

  • Investigational Site 461

    Ōsaka, 596-8522

  • Investigational Site 459

    Saitama, 348-0044

  • Investigational Site 467

    Shimonoseki, 750-8520

  • Investigational Site 451

    Tokyo, 171-0014

  • Investigational Site 463

    Yamaguchi, 750-8520

Other trials in Japan

Brazil15 sites

  • Study site

    Aparecida de Goiânia, Goiás, 74935-530

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Belo Horizonte, Minas Gerais, 30190-130

  • Study site

    Campinas, 13020431

  • Study site

    Canoas, Rio Grande do Sul, 92425-900

  • Study site

    Curitiba, Paraná, 80810-040

  • Study site

    Juiz de Fora, Minas Gerais, 36010-570

  • Study site

    Natal, Rio Grande do Norte, 59025-600

  • Study site

    Nova Iguaçu, Rio de Janeiro, 26030-380

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Recife, Pernambuco, 52020-010

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Study site

    Salvador, Estado de Bahia, 40420-000

  • Study site

    Salvador, Estado de Bahia, 41253-190

  • Study site

    Santo André, São Paulo, 09060-650

Other trials in Brazil

Canada13 sites

  • Study site

    Guelph, Ontario, N1H 1B1

  • Study site

    Halifax, Nova Scotia, B3K 6R8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    New Westminster, British Columbia, V3L 3W7

  • Study site

    Pierrefonds, Quebec, H9H 4Y6

  • Investigational Site 152

    Québec, Quebec, G1E 7G9

  • Investigational Site 151

    Sherbrooke, Quebec, J1H5N4

  • Investigational Site 156

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Toronto, Ontario, M5G 1X5

  • Investigational Site 161

    Trois-Rivières, Quebec, G8Z 3R9

  • Investigational Site 163

    Truro, Nova Scotia, B2N 1L2

  • Investigational Site 158

    Vancouver, British Columbia, V5Z IM9

  • Study site

    Winnipeg, Manitoba, R3A IR9

Other trials in Canada

Germany13 sites

  • Study site

    Berlin, 10629

  • Study site

    Berlin, 13347

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Investigational Site 244

    Deggingen, Baden-Wurttemberg, 73326

  • Study site

    Essen, 45355

  • Study site

    Goch, 47574

  • Investigational Site 247

    Hamburg, 20359

  • Investigational Site 245

    Hamburg, 22143

  • Study site

    Jena, Thuringia, 07747

  • Study site

    Leipzig, Saxony, 04109

  • Study site

    Leipzig, 97074

  • Study site

    Munich, Bavaria, 81675

  • Investigational Site 242

    Würzburg, Bavaria, 97074

Other trials in Germany

Mexico13 sites

  • Study site

    Aguascalientes, Aguascalientes, 20230

  • Investigational Site 363

    Ciudad Victoria, Tamaulipas

  • Investigational Site 351

    Cuernavaca, Morelos, 62290

  • Investigational Site 326

    Durango, 34000

  • Investigational Site 352

    Ecatepec de Morelos, State of Mexico, 55076

  • Investigational Site 324

    Guadalajara, Jalisco, 44280

  • Investigational Site 325

    Mexico City, D.F., 14000

  • Investigational Site 329

    Mexico City, D.F., 14080

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Morelos

  • Study site

    San Luis Potosí City, San Luis Potosí, 78240

  • Study site

    San Luis Potosí City, 78240

  • Study site

    Tijuana, Estado de Baja California, 22320

Other trials in Mexico

France12 sites

  • Investigational Site 230

    Dijon, 21079

  • Study site

    Lille, 49100

  • Study site

    Limoges, 87042

  • Study site

    Lyon, 69004

  • Study site

    Montpellier, 34295

  • Study site

    Orléans, 45100

  • Investigational Site 221

    Paris, 75014

  • Investigational Site 229

    Pringy, 21079

  • Study site

    Saint-Etienne, 42055

  • Investigational Site 223

    Saint-Priest-en-Jarez, 42270

  • Study site

    Tourcoing, 59208

  • Investigational Site 232

    Tours, 37044

Other trials in France

United Kingdom12 sites

  • Investigational Site 276

    Blackpool, FY3 7EN

  • Study site

    Blackpool, FY3 8NR

  • Investigational Site 277

    Coventry, CV2 2DX

  • Study site

    Harrow, HA1 3UJ

  • Investigational Site 281

    Leeds, LS9 7TF

  • Study site

    Liverpool, L78XP

  • Investigational Site 271

    London, SW17 0RE

  • Study site

    Manchester, M8 5RB

  • Study site

    Middlesex, HA1 3UJ

  • Study site

    North Shields, NE29 8NH

  • Investigational Site 275

    Penzance, TR19 7HX

  • Study site

    Stoke-on-Trent, SR53SY

Other trials in United Kingdom

Finland11 sites

  • Study site

    Espoo, FIN-02100

  • Study site

    Helsinki, FIN-00100

  • Study site

    Helsinki, FIN-00930

  • Investigational Site 203

    Jarvenpaa, FIN-04400

  • Study site

    Kokkola, 67100

  • Study site

    Oulu, FIN-90220

  • Study site

    Pori, 28100

  • Study site

    Seinäjoki, 60100

  • Investigational Site 201

    Tampere, FIN-33100

  • Investigational Site 202

    Turku, FIN-20520

  • Study site

    Vantaa, FIN-01300

Other trials in Finland

Peru9 sites

  • Investigational Site 332

    Jesus Maria, Lima region, lima 11

  • Investigational Site 356

    Lima, callao 2

  • Investigational Site 355

    Lima, lima 1

  • Study site

    Lima

  • Study site

    Lima Cercado, Lima region

  • Investigational Site 365

    Piura, 200101

  • Investigational Site 334

    San Martín de Porres, Lima region, lima 31

  • Study site

    Surquillo, Lima region

  • Investigational Site 364

    Trujillo, La Libertad, 130101

Other trials in Peru

Colombia8 sites

  • Study site

    Armenia, Quindío Department

  • Study site

    Barranquilla, Alantico

  • Study site

    Bogotá, Ditrito Capital

  • Study site

    Bogotá, Ditrito

  • Study site

    Bucaramanga, Santander Department

  • Study site

    Floridablanca, Santander Department

  • Study site

    Medellín, Antioquia

  • Study site

    Yopal

Other trials in Colombia

Australia7 sites

  • Investigational Site 404

    Bedford Park, South Australia, 5042

  • Investigational Site 401

    Cairns, Queensland, 4870

  • Investigational Site 403

    Clayton, Victoria, 3168

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Subiaco, Western Australia, 6008

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Philippines7 sites

  • Study site

    Alabang, 1770

  • Study site

    Dasmariñas, 4114

  • Study site

    Manila, 1000

  • Study site

    Manila, 1004

  • Study site

    Pasig, 1600

  • Study site

    Quezon City, 1100

  • Study site

    Quezon City, 1101

Other trials in Philippines

Taiwan7 sites

  • Study site

    Kaohsiung City, 813

  • Investigational Site 426

    New Taipei City, 22056

  • Study site

    New Taipei City, 23156

  • Investigational Site 429

    Taichung, 40201

  • Investigational Site 421

    Tainan, 71004

  • Investigational Site 425

    Taipei, 10002

  • Study site

    Tiachung, 404

Other trials in Taiwan

Singapore5 sites

  • Study site

    Singapore, 119074

  • Investigational Site 419

    Singapore, 119228

  • Study site

    Singapore, 169608

  • Investigational Site 428

    Singapore, 308433

  • Investigational Site 445

    Singapore, 768828

Other trials in Singapore

Spain4 sites

  • Investigational Site 294

    Córdoba, 14004

  • Investigational Site 293

    Santander, 39008

  • Investigational Site 292

    Terrassa, 08221

  • Investigational Site 295

    Vigo, 36312

Other trials in Spain

Sweden3 sites

  • Study site

    Göthenburg, SWE, 41685

  • Study site

    Stockholm, 11157

  • Study site

    Umeå, 90185

Other trials in Sweden

Thailand3 sites

  • Investigational Site 443

    Bangkok, 10330

  • Investigational Site 442

    Bangkok, 10400

  • Investigational Site 441

    Khon Kaen, 40002

Other trials in Thailand

Poland2 sites

  • Investigational Site 284

    Bydgoszcz, 85-863

  • Investigational Site 283

    Nowy Duninów, 09-505

Other trials in Poland

Puerto Rico2 sites

  • Investigational Site 171

    Bayamón, PR, 00960

  • Study site

    Bayamón, 00961

Other trials in Puerto Rico

Costa Rica1 site

  • Study site

    San José, 250-1000

Other trials in Costa Rica

Denmark1 site

  • Investigational Site 215

    Aarhus, 8200

Other trials in Denmark

Dominican Republic1 site

  • Investigational Site 347

    Santo Domingo

Other trials in Dominican Republic

Guatemala1 site

  • Study site

    Guatemala City, 1001

Other trials in Guatemala

Panama1 site

  • Investigational Site 354

    Panama City

Other trials in Panama

About this study

Official title: Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)

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:

Read more
  • 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.
Read the detailed description

The study was 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. Analyses of trial futility (non-efficacy) were to be performed at the first 2 interim analyses, and the study was to be stopped if either of those analyses provided robust and compelling evidence that meaningful levels of vaccine efficacy (VE) would not be demonstrated.

Following completion of the first interim analysis (50 cases of confirmed CDI observed), the futility criterion was met and in accordance with IDMC recommendation, enrollment and further vaccination ceased in November 2017.

Due to the early termination of the study, some of the planned secondary efficacy endpoints could not be analyzed as all planned data were not collected.

Participants were randomized to receive either the candidate vaccine or a placebo that was to be administered in a 3-dose schedule. At the time of group assignment, 928 participants (10% of total enrollment) were randomized to an immunogenicity subset; and 1859 participants (20% of total enrollment) were randomized to a reactogenicity subset.

Safety was assessed in all participants in terms of unsolicited adverse events from Day 0 to Day 60, as well as serious adverse events (SAEs) throughout the study. Solicited adverse reactions were collected for 6 days following each injection in the reactogenicity subset.

Being tested
C. difficile Toxoid Vaccine, Placebo: 0.9% normal saline
Keywords
Clostridium difficile Toxoid Vaccine, Clostridium difficile infection, Cdiffense
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C. difficile Toxoid VaccineBiological

    0.5 mL, Intramuscular

  • Placebo: 0.9% normal salineBiological

    0.5 mL, Intramuscular

Study groups in NCT01887912
Study groupRoleWhat they receive
C. difficile Vaccine GroupExperimentalParticipants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Receives: Biological: C. difficile Toxoid Vaccine
Placebo GroupPlacebo comparatorParticipants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
Receives: Biological: Placebo: 0.9% normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 years post injection 1

Secondary outcomes (10)

  1. Number of Participants With Severe PCR-Confirmed Primary CDI Cases

    Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever >= 38.5 degree Celsius (°C), white blood cell count >= 15,000 cells/mm^3, ileus, pseudomembranous colitis, serum albumin <3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.

    Measured: Up to 3 years post injection 1

  2. Number of Participants With Loose Stool Episodes

    Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.

    Measured: Up to 3 years post injection 1

  3. Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population

    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. Analysis was performed on per-protocol efficacy analysis set (PPEAS).

    Measured: Up to 3 years post injection 1

  4. Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).

    Measured: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110

  5. Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA

    Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.

    Measured: Day 60

  6. Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI

    Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. 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.

    Measured: Day 0 and Day 60

  7. Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)

    Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.

    Measured: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110

  8. Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA

    Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.

    Measured: Day 60

  9. Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI

    Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. 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.

    Measured: Day 0 and Day 60

  10. Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions

    Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: >= 25 to <=50 mm, Grade 2: >51 to <=100 mm, Grade 3: >100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: >= 38.0°C to <=38.4°C or >= 100.4° Fahrenheit (F) to <=101.1°F, Grade 2: >=38.5°C to <= 38.9°C or >=101.2°F to <=102.0°F, Grade 3: >=39.0°C or >=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.

    Measured: Day 0 to Day 6 after any vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study start30 Jul 2013
  3. Primary completion12 Jun 2018
  4. Study completion12 Jun 2018

Why it stopped: The Independent Data Monitoring Committee (IDMC) concluded that the probability that the study will meet its primary objective is low.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study was observer-blind. The vaccine preparer and administrator may have been unblinded to treatment assignment due to the steps necessary for vaccine preparation. However, the participant, the Investigator, and study staff members who collected the safety data and laboratory personnel who analyzed the blood and stool samples were all blinded to the group assignment.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
9,302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887912
Sponsor's protocol ID
H-030-014
Other IDs
2013-000775-32, U1111-1127-7162
Status last verified
Mar 2022
First submitted
20 Jun 2013
Last updated
28 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 32946836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing C. difficile Toxoid Vaccine in people with Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 335 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 335 sites in United States, South Korea, Japan, Brazil, Canada and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases (time frame: Up to 3 years post injection 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01887912, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

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