Une étude sur un vaccin contre Clostridioides difficile chez les personnes de 65 ans et plus (BEETHOVEN)
4 novembre 2026 mis à jour par: Pfizer
ÉTUDE DE PHASE 3, CONTRÔLÉE PAR PLACEBO, EN DOUBLE AVEUGLE ET RANDOMISÉE POUR ÉVALUER L'EFFICACITÉ, L'INNOCUITÉ ET LA TOLÉRABILITÉ D'UN VACCIN CONTRE CLOSTRIDIOIDES DIFFICILE CHEZ LES ADULTES ÂGÉS DE 65 ANS ET PLUS
The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older.
The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle.
This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly does not work. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years.
During this time, participants will have 3 planned clinic visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study.
Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
32500
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentine, 1039
- Recrutement
- Sanatorio Sagrado Corazón
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La Plata, Buenos Aires, Argentine, 1900
- Recrutement
- Instituto Médico Platense (IMP)
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Mar del Plata, Buenos Aires, Argentine, 7600
- Recrutement
- Clinica Del Niño Y La Madre
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentine, 1425
- Recrutement
- Centro Medico Barrio Parque
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Buenos Aires, Buenos Aires F.D., Argentine, C1428BNF
- Recrutement
- Equipo Ciencia
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Buenos Aires, Buenos Aires F.D., Argentine, 1427
- Recrutement
- Fundación Huésped
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Córdoba Province
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Córdoba, Córdoba Province, Argentine, X5000IIH
- Recrutement
- Clinica Privada del Sol S.A
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Mendoza Province
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Lujan de Cuyo, Mendoza Province, Argentine, 5505
- Recrutement
- CDC Centro Médico
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Salta Province
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Salta, Salta Province, Argentine, A4400
- Recrutement
- Investigaciones Clínicas Salta (ICSAL)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentine, 4000
- Recrutement
- Clinica Mayo de Urgencias Médicas Cruz Blanca S.R.L
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San Miguel de Tucumán, Tucumán Province, Argentine, 4000
- Recrutement
- Hospital de Clinicas Presidente Nicolas Avellaneda
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 457-8511
- Recrutement
- Kojunkai Daido Clinic
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Nagoya, Aichi-ken, Japon, 462-0802
- Recrutement
- Kamiiida daiichi General Hospital
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Fukuoka
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Iizuka-shi, Fukuoka, Japon, 820-8505
- Recrutement
- Aso Iizuka Hospital
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Itoshima, Fukuoka, Japon, 819-1104
- Recrutement
- Seishinkai Inoue Hospital
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Kitakyushu-shi, Fukuoka, Japon, 806-8501
- Recrutement
- Japan Community Healthcare Organization Kyushu Hospital
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Onga-gun, Fukuoka, Japon, 807-0051
- Recrutement
- Fukuoka Shinmizumaki Hospital
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Ibaraki
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Koga, Ibaraki, Japon, 306-0041
- Recrutement
- Koga General Hospital
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Kumamoto
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Kumamoto, Kumamoto, Japon, 861-8520, 862-8520
- Recrutement
- Japanese Red Cross Kumamoto Hospital
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Nagasaki
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Ōmura, Nagasaki, Japon, 856-8562
- Recrutement
- National Hospital Organization Nagasaki Medical Center
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Okinawa
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Shimajiri, Okinawa, Japon, 901-0417
- Recrutement
- Nanbu Tokushukai Hospital
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Osaka
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Daitō, Osaka, Japon, 574-0074
- Recrutement
- Nozaki Tokushukai Hospital
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Saga-ken
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Saga, Saga-ken, Japon, 849-8501
- Recrutement
- Saga University Hospital
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Tokyo
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Chuo-ku, Tokyo, Japon, 103-0027
- Recrutement
- Tokyo-Eki Center-building Clinic
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Shinjuku, Tokyo, Japon, 162-8655
- Recrutement
- National Center for Global Health and Medicine
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Birmingham, Royaume-Uni, B16 8QQ
- Recrutement
- Synexus Midlands Clinical Research Centre
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Glasgow, Royaume-Uni, G51 4RY
- Recrutement
- Panthera Biopartners - Glasgow
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Manchester, Royaume-Uni, M13 9WU
- Recrutement
- Manchester Royal Infirmary
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CORNWALL
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Newquay, CORNWALL, Royaume-Uni, TR7 1RU
- Recrutement
- Newquay Health Centre
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DEVON
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Exeter, DEVON, Royaume-Uni, EX2 5DW
- Recrutement
- Royal Devon & Exeter Hospital
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Plymouth, DEVON, Royaume-Uni, PL5 3JB
- Recrutement
- Knowle House Surgery
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Torquay, DEVON, Royaume-Uni, TQ1 4QX
- Recrutement
- Brunel Medical Practice (St Marychurch)
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England
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Preston, England, Royaume-Uni, PR2 9QB
- Recrutement
- Panthera Biopartners - Preston
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GLASGOW CITY
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Glasgow, GLASGOW CITY, Royaume-Uni, ML4 3NJ
- Pas encore de recrutement
- Synexus Scotland Clinical Research Centre
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HAMPSHIRE
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Southampton, HAMPSHIRE, Royaume-Uni, SO16 6YD
- Recrutement
- Southampton General Hospital
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LANCASHIRE
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Blackpool, LANCASHIRE, Royaume-Uni, FY3 7EN
- Recrutement
- Layton Medical Centre
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MANCHESTER
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Manchester, MANCHESTER, Royaume-Uni, M15 6SE
- Recrutement
- Synexus Manchester Clinical Research Centre
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Rochdale, MANCHESTER, Royaume-Uni, OL11 4AU
- Recrutement
- Panthera Biopartners - Manchester
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NORTH YORKSHIRE
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York, NORTH YORKSHIRE, Royaume-Uni, YO24 4LJ
- Recrutement
- Panthera Clinic - York
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Northamptonshire
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Corby, Northamptonshire, Royaume-Uni, NN17 2UR
- Recrutement
- Lakeside Surgery
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Northern Ireland
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Belfast, Northern Ireland, Royaume-Uni, BT2 8BG
- Recrutement
- Ormeau Clinical Trials
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SHEFFIELD
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Sheffield, SHEFFIELD, Royaume-Uni, S2 5FX
- Recrutement
- Panthera Biopartners - Sheffield
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STAFFORDSHIRE
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Cheadle, STAFFORDSHIRE, Royaume-Uni, ST10 1NS
- Recrutement
- Cheadle Community Hospital
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Alabama
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Athens, Alabama, États-Unis, 35611
- Recrutement
- North Alabama Research Center
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Guntersville, Alabama, États-Unis, 35976
- Recrutement
- Lakeview Clinical Research
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Huntsville, Alabama, États-Unis, 35801
- Recrutement
- Medical Affiliated Research Center
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Arizona
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Chinle, Arizona, États-Unis, 86503
- Recrutement
- Chinle Center for Indigenous Health
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Chinle, Arizona, États-Unis, 86503
- Recrutement
- Chinle Comprehensive Health Care Facility
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Sun City, Arizona, États-Unis, 85351
- Recrutement
- Epic Medical Research-Sun City
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Recrutement
- Applied Research Center of Arkansas
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California
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Daly City, California, États-Unis, 94015
- Recrutement
- Kaiser Permanente Daly City
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Los Angeles, California, États-Unis, 90027
- Recrutement
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, États-Unis, 90027
- Recrutement
- Kaiser Permanente Oncology Pharmacy #014C
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Mather, California, États-Unis, 95655
- Recrutement
- Sacramento VA Medical Center
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Oakland, California, États-Unis, 94611
- Recrutement
- Kaiser Permanente Oakland
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Ontario, California, États-Unis, 91761
- Recrutement
- Kaiser Permanente Ontario Medical Center
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Roseville, California, États-Unis, 95661
- Recrutement
- Kaiser Permanente Roseville
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Sacramento, California, États-Unis, 95815
- Recrutement
- Kaiser Permanente Sacramento
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Sacramento, California, États-Unis, 95823
- Recrutement
- Kaiser Permanente South Sacramento
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San Bernardino, California, États-Unis, 92408
- Recrutement
- Velocity Clinical Research, San Bernardino
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San Diego, California, États-Unis, 92123
- Recrutement
- Kaiser Permanente - San Diego Medical Center
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San Diego, California, États-Unis, 92123
- Recrutement
- Kaiser Permanente Viewridge Medical Office
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San Jose, California, États-Unis, 95119
- Recrutement
- Kaiser Permanente San Jose
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San Mateo, California, États-Unis, 94403
- Actif, ne recrute pas
- Carbon Health - San Mateo - Hillsdale Mall
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Santa Clara, California, États-Unis, 95051
- Recrutement
- Kaiser Permanente Santa Clara
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Toluca Lake, California, États-Unis, 91602
- Recrutement
- Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
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Walnut Creek, California, États-Unis, 94598
- Recrutement
- Diablo Clinical Research, Inc.
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Walnut Creek, California, États-Unis, 94596
- Recrutement
- Kaiser Permanente Walnut Creek
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20037
- Recrutement
- GW Vaccine Research Unit
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Washington D.C., District of Columbia, États-Unis, 20037
- Recrutement
- The GW Medical Faculty Associates
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Florida
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Bay Pines, Florida, États-Unis, 33744
- Recrutement
- Bay Pines VA Healthcare System
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Fort Lauderdale, Florida, États-Unis, 33308
- Recrutement
- Proactive Clinical Research,LLC
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Jacksonville, Florida, États-Unis, 32256
- Recrutement
- Clinical Neuroscience Solutions, LLC
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Lake City, Florida, États-Unis, 32055
- Recrutement
- M3 Wake Research - Lake City
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Medley, Florida, États-Unis, 33166
- Recrutement
- South Florida Research Organization
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Miami, Florida, États-Unis, 33176
- Recrutement
- Entrust Clinical Research
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Miami, Florida, États-Unis, 33130
- Recrutement
- Care Research Inc
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Miami Lakes, Florida, États-Unis, 33014
- Recrutement
- Charisma Medical and Research Center
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Miami Lakes, Florida, États-Unis, 33014
- Recrutement
- Palm Springs Community Health Center
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Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Indago Research & Health Center, Inc
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Tampa, Florida, États-Unis, 33614
- Recrutement
- Angels Clinical Research Institute
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Georgia
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Atlanta, Georgia, États-Unis, 30303
- Recrutement
- Emory Steiner Building Research Center
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Atlanta, Georgia, États-Unis, 30303
- Recrutement
- Emory University Woodruff Extension Building (WEB)
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Columbus, Georgia, États-Unis, 31904
- Recrutement
- Centricity Research Columbus Georgia Multispecialty
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Decatur, Georgia, États-Unis, 30033
- Recrutement
- Atlanta VA Medical Center
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Decatur, Georgia, États-Unis, 30030
- Recrutement
- The Hope Clinic of Emory University
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Savannah, Georgia, États-Unis, 31406
- Recrutement
- Velocity Clinical Research, Savannah
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Illinois
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Melrose Park, Illinois, États-Unis, 60160
- Recrutement
- DM Clinical Research - Chicago
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Iowa
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Ames, Iowa, États-Unis, 50010
- Recrutement
- McFarland Clinic, PC
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Ames, Iowa, États-Unis, 50010
- Recrutement
- Accellacare - McFarland
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Sioux City, Iowa, États-Unis, 51106
- Recrutement
- Velocity Clinical Research, Sioux City
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Kansas
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Newton, Kansas, États-Unis, 67114
- Recrutement
- AMR Clinical
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70836
- Recrutement
- Ochsner Medical Complex - The Grove
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Kenner, Louisiana, États-Unis, 70065
- Recrutement
- Ochsner Clinic Foundation - Kenner Clinical Trials Unit
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Lafayette, Louisiana, États-Unis, 70503
- Recrutement
- Ochsner Lafayette General Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21205
- Recrutement
- Johns Hopkins Bloomberg School of Public Health
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Baltimore, Maryland, États-Unis, 21231
- Recrutement
- Johns Hopkins Bloomberg School of Public Health
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Massachusetts
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West Roxbury, Massachusetts, États-Unis, 02132
- Recrutement
- VA Boston Healthcare System - West Roxbury
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Michigan
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Southfield, Michigan, États-Unis, 48076
- Recrutement
- DM Clinical Research - Detroit
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Southfield, Michigan, États-Unis, 48075
- Recrutement
- Revive Research Institute, Inc.
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University School of Medicine
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St Louis, Missouri, États-Unis, 63141
- Recrutement
- Sundance Clinical Research
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Nebraska
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Grand Island, Nebraska, États-Unis, 68803
- Recrutement
- Velocity Clinical Research, Grand Island
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Omaha, Nebraska, États-Unis, 68105
- Recrutement
- University of Nebraska Medical Center
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Omaha, Nebraska, États-Unis, 68134
- Recrutement
- Velocity Clinical Research, Omaha
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Omaha, Nebraska, États-Unis, 68198
- Recrutement
- University Of Nebraska Medical Center
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Nevada
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Reno, Nevada, États-Unis, 89502
- Recrutement
- Renown Regional Medical Center
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Reno, Nevada, États-Unis, 89502
- Recrutement
- Renown Center for Advanced Medicine
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Reno, Nevada, États-Unis, 89519
- Recrutement
- University Health
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Recrutement
- HMH Hackensack University Medical Center
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Hackensack, New Jersey, États-Unis, 07601
- Recrutement
- Hackensack Meridian Health Hackensack University Medical Center
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Hackensack, New Jersey, États-Unis, 07601
- Recrutement
- HMH David Jurist Research Building
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Neptune City, New Jersey, États-Unis, 07753
- Recrutement
- Hackensack Meridian Health Jersey Shore University Medical Center
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Neptune City, New Jersey, États-Unis, 07753
- Recrutement
- HOPE Tower at Jersey Shore University Medical Center
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New Brunswick, New Jersey, États-Unis, 08901
- Recrutement
- Rutgers Robert Wood Johnson Medical School
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Somers Point, New Jersey, États-Unis, 08244
- Recrutement
- South Jersey Infectious Disease
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- Recrutement
- Albuquerque Clinical Trials, Inc.
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Gallup, New Mexico, États-Unis, 87301
- Recrutement
- Gallup Center for Indigenous Health
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Gallup, New Mexico, États-Unis, 87301
- Recrutement
- Gallup Indian Medical Center
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Shiprock, New Mexico, États-Unis, 87420
- Recrutement
- Shiprock Center for Indigenous Health
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Shiprock, New Mexico, États-Unis, 87420
- Recrutement
- Northern Navajo Medical Center
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New York
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Brooklyn, New York, États-Unis, 11220
- Recrutement
- NYU Langone Health
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East Syracuse, New York, États-Unis, 13057
- Recrutement
- Upstate Global Health Institute
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Long Island City, New York, États-Unis, 11102
- Recrutement
- Mount Sinai Queens
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Manhasset, New York, États-Unis, 11030
- Recrutement
- North Shore University Hospital
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Manhasset, New York, États-Unis, 11030
- Recrutement
- Northwell Health Infectious Disease
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Mineola, New York, États-Unis, 11501
- Recrutement
- NYU Langone Health
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Mount Kisco, New York, États-Unis, 10549
- Recrutement
- Northern Westchester Hospital
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New York, New York, États-Unis, 10016
- Recrutement
- NYU Langone Health
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New York, New York, États-Unis, 10032
- Recrutement
- Columbia University Irving Medical Center
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New York, New York, États-Unis, 10029
- Recrutement
- Icahn School of Medicine at Mount Sinai
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New York, New York, États-Unis, 10019
- Recrutement
- Mount Sinai West
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New York, New York, États-Unis, 10025
- Recrutement
- Mount Sinai Morningside
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Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research, LLC
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Sleepy Hollow, New York, États-Unis, 10591
- Recrutement
- Phelps Hospital Geriatric Medicine & Improvement Science
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Staten Island, New York, États-Unis, 10305
- Recrutement
- Staten Island University Hospital
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The Bronx, New York, États-Unis, 10468
- Recrutement
- James J. Peters VA Medical Center
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The Bronx, New York, États-Unis, 10467
- Recrutement
- Montefiore Medical Center
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North Carolina
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Cary, North Carolina, États-Unis, 27518
- Recrutement
- Accellacare - Cary
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Durham, North Carolina, États-Unis, 27703
- Recrutement
- Duke Vaccine and Trials Unit
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Greensboro, North Carolina, États-Unis, 27401
- Recrutement
- Medication Management
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Hickory, North Carolina, États-Unis, 28601
- Recrutement
- Accellacare - Hickory
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High Point, North Carolina, États-Unis, 27262
- Recrutement
- Atrium Health Wake Forest Baptist Infectious Disease-High Point
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Accellacare - Raleigh
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Duke University Health System
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Raleigh Medical Group P.A.
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Duke University Health System-Duke Vaccine and Trials Unit Raleigh
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Salisbury, North Carolina, États-Unis, 28144
- Recrutement
- Accellacare - Salisbury
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Wilmington, North Carolina, États-Unis, 28401
- Recrutement
- Accellacare - Wilmington
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Wilmington, North Carolina, États-Unis, 28401
- Recrutement
- Wilmington Health, PLLC
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Winston-Salem, North Carolina, États-Unis, 27157
- Recrutement
- Wake Forest Baptist Health
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Winston-Salem, North Carolina, États-Unis, 27103
- Recrutement
- Accellacare - Winston-Salem
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Ohio
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Cincinnati, Ohio, États-Unis, 45212
- Recrutement
- CTI Clinical Research Center
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- VA Northeast Ohio Healthcare System Louis Stokes Cleveland VA Medical Center
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Oregon
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Portland, Oregon, États-Unis, 97227
- Recrutement
- Kaiser Permanente Center for Health Research
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Pennsylvania
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Camp Hill, Pennsylvania, États-Unis, 17011
- Recrutement
- Capital Area Research, LLC
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Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- DM Clinical Research - Philadelphia
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South Carolina
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Little River, South Carolina, États-Unis, 29566
- Recrutement
- Walker Family Care
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Spartanburg, South Carolina, États-Unis, 29303
- Recrutement
- Velocity Clinical Research, Spartanburg
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Tennessee
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Knoxville, Tennessee, États-Unis, 37909
- Recrutement
- New Phase Research and Development
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Memphis, Tennessee, États-Unis, 38119
- Recrutement
- Clinical Neuroscience Solutions, LLC
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt University Medical Center
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Nashville, Tennessee, États-Unis, 37212
- Recrutement
- The Vanderbilt Vaccine Research Program Clinic at The Village at Vanderbilt
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt Investigational Drug Service (IDS)
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt Vaccine Research Program Laboratory
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt Vaccine Research Program
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Texas
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Dallas, Texas, États-Unis, 75246
- Recrutement
- North Texas Infectious Diseases Consultants, P.A
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Dallas, Texas, États-Unis, 75237
- Recrutement
- Family Health Watch - KeyPoint Clinical Research
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Dallas, Texas, États-Unis, 75240
- Recrutement
- KeyPoint Clinical Research
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Euless, Texas, États-Unis, 76040
- Recrutement
- Cedar Health Research - Euless
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Houston, Texas, États-Unis, 77030
- Recrutement
- Baylor College of Medicine
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Houston, Texas, États-Unis, 77030
- Recrutement
- The University of Texas Health Science Center at Houston
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Houston, Texas, États-Unis, 77065
- Recrutement
- DM Clinical Research- Cyfair
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Houston, Texas, États-Unis, 77087
- Recrutement
- Mercury Clinical Research - Santa Clara Family Clinic
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Houston, Texas, États-Unis, 77030
- Recrutement
- UT Physicians
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Houston, Texas, États-Unis, 77030
- Recrutement
- Memorial Hermann Hospital - TMC
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Tomball, Texas, États-Unis, 77375
- Recrutement
- Northwest Houston Heart Center
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Tomball, Texas, États-Unis, 77375
- Recrutement
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, États-Unis, 84121
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Vermont
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Burlington, Vermont, États-Unis, 05401
- Recrutement
- The University of Vermont Medical Center Inc.
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Burlington, Vermont, États-Unis, 05401
- Recrutement
- UVM Larner College of Medicine MMG/VCT
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Virginia
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Richmond, Virginia, États-Unis, 23226
- Recrutement
- Clinical Research Partners, LLC
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Washington
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Everett, Washington, États-Unis, 98201
- Recrutement
- Providence Regional Medical Center Everett
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Seattle, Washington, États-Unis, 98104
- Recrutement
- University of Washington - Harborview Medical Center
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Seattle, Washington, États-Unis, 98101
- Recrutement
- Kaiser Permanente Washington Health Research Institute (KPWHRI)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Who Can Join the Study (Inclusion Criteria):
• People with recent or future planned contact with healthcare systems, recent antibiotic exposure, or a diagnosis of certain chronic medical conditions.
Who Cannot Join the Study (Exclusion Criteria):
- Anyone who has had CDI before.
- Anyone who has had surgery to remove part of their small or large intestine.
- Anyone who often has diarrhea (meaning three or more loose stools in a day, more than once a month).
- Anyone who has already received a vaccine or special antibody treatment for C. difficile.
- Anyone who has had a serious allergic reaction to a vaccine or to any part of the study vaccines.
- Anyone who might not respond well to the vaccine because their immune system is weak (either from a disease or from treatment).
- Anyone with cancer that has spread or another serious health problem.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Placebo salin
|
0.9% sodium chloride solution given as a intramuscular injection |
|
Expérimental: C.difficile vaccine
Novel vaccine formulation |
C.difficile vaccine given as an intramuscular injection |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The percentage of participants reporting local reactions
Délai: For 7 days after each vaccination
|
Injection site pain, redness, and swelling as self-reported in electronic diaries |
For 7 days after each vaccination
|
|
The percentage of participants reporting systemic events
Délai: For 7 days after each vaccination
|
Fever, vomiting, fatigue, headache, muscle pain, and joint pain as self-reported in electronic diaries |
For 7 days after each vaccination
|
|
Percentage of participants reporting adverse events
Délai: From each vaccination through 1 month after each vaccination
|
As elicited by investigator site staff |
From each vaccination through 1 month after each vaccination
|
|
Percentage of participants reporting serious adverse events
Délai: From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)
|
As elicited by investigator site staff |
From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)
|
|
The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of medically attended and clinically meaningful primary CDI incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
|
The incidence of the first episode of medically attended primary CDI
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of medically attended primary CDI incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
|
The incidence of the first episode of clinically meaningful primary CDI
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of clinically meaningful primary CDI incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of antibiotic use in the treatment of a first episode of the primary CDI
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of primary CDI with antibiotic use incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
|
The incidence of severe or fulminant primary CDI
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of severe or fulminant primary CDI incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
|
The incidence of a first episode of primary CDI (any severity)
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
First episode of primary CDI incidence per 1000 person- years of follow- up |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
|
The incidence of all CDI (primary and recurrent)
Délai: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
Occurence of all C.difficile infection cases |
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 décembre 2025
Achèvement primaire (Estimé)
11 décembre 2028
Achèvement de l'étude (Estimé)
7 juin 2029
Dates d'inscription aux études
Première soumission
5 décembre 2025
Première soumission répondant aux critères de contrôle qualité
5 décembre 2025
Première publication (Réel)
15 décembre 2025
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- C4771002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .