Een studie om meer te leren over een Clostridioides difficile-vaccin bij personen van 65 jaar en ouder (BEETHOVEN)
4 november 2026 bijgewerkt door: Pfizer
EEN FASE 3, PLACEBO-GECONTROLLEERDE, DUBBELBLINDE, GERANDOMISEERDE STUDIE OM DE EFFECTIVITEIT, VEILIGHEID EN TOLERANTIE VAN EEN CLOSTRIDIOIDES DIFFICILE-VACCIN TE EVALUEREN BIJ VOLWASSENEN VAN 65 JAAR EN OUDER
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
32500
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentinië, 1039
- Werving
- Sanatorio Sagrado Corazón
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La Plata, Buenos Aires, Argentinië, 1900
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- Instituto Médico Platense (IMP)
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Mar del Plata, Buenos Aires, Argentinië, 7600
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- Clinica Del Niño Y La Madre
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentinië, 1425
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- Centro Medico Barrio Parque
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Buenos Aires, Buenos Aires F.D., Argentinië, C1428BNF
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- Equipo Ciencia
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Buenos Aires, Buenos Aires F.D., Argentinië, 1427
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- Fundación Huésped
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Córdoba Province
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Córdoba, Córdoba Province, Argentinië, X5000IIH
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- Clinica Privada del Sol S.A
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Mendoza Province
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Lujan de Cuyo, Mendoza Province, Argentinië, 5505
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- CDC Centro Médico
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Salta Province
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Salta, Salta Province, Argentinië, A4400
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- Investigaciones Clínicas Salta (ICSAL)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentinië, 4000
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- Clinica Mayo de Urgencias Médicas Cruz Blanca S.R.L
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San Miguel de Tucumán, Tucumán Province, Argentinië, 4000
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- Hospital de Clinicas Presidente Nicolas Avellaneda
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 457-8511
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- Kojunkai Daido Clinic
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Nagoya, Aichi-ken, Japan, 462-0802
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- Kamiiida daiichi General Hospital
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Fukuoka
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Iizuka-shi, Fukuoka, Japan, 820-8505
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- Aso Iizuka Hospital
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Itoshima, Fukuoka, Japan, 819-1104
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- Seishinkai Inoue Hospital
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Kitakyushu-shi, Fukuoka, Japan, 806-8501
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- Japan Community Healthcare Organization Kyushu Hospital
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Onga-gun, Fukuoka, Japan, 807-0051
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- Fukuoka Shinmizumaki Hospital
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Ibaraki
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Koga, Ibaraki, Japan, 306-0041
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- Koga General Hospital
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-8520, 862-8520
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- Japanese Red Cross Kumamoto Hospital
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Nagasaki
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Ōmura, Nagasaki, Japan, 856-8562
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- National Hospital Organization Nagasaki Medical Center
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Okinawa
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Shimajiri, Okinawa, Japan, 901-0417
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- Nanbu Tokushukai Hospital
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Osaka
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Daitō, Osaka, Japan, 574-0074
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- Nozaki Tokushukai Hospital
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Saga-ken
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Saga, Saga-ken, Japan, 849-8501
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- Saga University Hospital
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Tokyo
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Chuo-ku, Tokyo, Japan, 103-0027
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- Tokyo-Eki Center-building Clinic
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Shinjuku, Tokyo, Japan, 162-8655
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- National Center for Global Health and Medicine
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Birmingham, Verenigd Koninkrijk, B16 8QQ
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- Synexus Midlands Clinical Research Centre
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Glasgow, Verenigd Koninkrijk, G51 4RY
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- Panthera Biopartners - Glasgow
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Manchester, Verenigd Koninkrijk, M13 9WU
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- Manchester Royal Infirmary
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CORNWALL
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Newquay, CORNWALL, Verenigd Koninkrijk, TR7 1RU
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- Newquay Health Centre
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DEVON
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Exeter, DEVON, Verenigd Koninkrijk, EX2 5DW
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- Royal Devon & Exeter Hospital
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Plymouth, DEVON, Verenigd Koninkrijk, PL5 3JB
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- Knowle House Surgery
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Torquay, DEVON, Verenigd Koninkrijk, TQ1 4QX
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- Brunel Medical Practice (St Marychurch)
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England
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Preston, England, Verenigd Koninkrijk, PR2 9QB
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- Panthera Biopartners - Preston
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GLASGOW CITY
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Glasgow, GLASGOW CITY, Verenigd Koninkrijk, ML4 3NJ
- Nog niet aan het werven
- Synexus Scotland Clinical Research Centre
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HAMPSHIRE
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Southampton, HAMPSHIRE, Verenigd Koninkrijk, SO16 6YD
- Werving
- Southampton General Hospital
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LANCASHIRE
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Blackpool, LANCASHIRE, Verenigd Koninkrijk, FY3 7EN
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- Layton Medical Centre
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MANCHESTER
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Manchester, MANCHESTER, Verenigd Koninkrijk, M15 6SE
- Werving
- Synexus Manchester Clinical Research Centre
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Rochdale, MANCHESTER, Verenigd Koninkrijk, OL11 4AU
- Werving
- Panthera Biopartners - Manchester
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NORTH YORKSHIRE
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York, NORTH YORKSHIRE, Verenigd Koninkrijk, YO24 4LJ
- Werving
- Panthera Clinic - York
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Northamptonshire
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Corby, Northamptonshire, Verenigd Koninkrijk, NN17 2UR
- Werving
- Lakeside Surgery
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Northern Ireland
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Belfast, Northern Ireland, Verenigd Koninkrijk, BT2 8BG
- Werving
- Ormeau Clinical Trials
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SHEFFIELD
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Sheffield, SHEFFIELD, Verenigd Koninkrijk, S2 5FX
- Werving
- Panthera Biopartners - Sheffield
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STAFFORDSHIRE
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Cheadle, STAFFORDSHIRE, Verenigd Koninkrijk, ST10 1NS
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- Cheadle Community Hospital
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Alabama
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Athens, Alabama, Verenigde Staten, 35611
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- North Alabama Research Center
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Guntersville, Alabama, Verenigde Staten, 35976
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- Lakeview Clinical Research
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Huntsville, Alabama, Verenigde Staten, 35801
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- Medical Affiliated Research Center
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Arizona
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Chinle, Arizona, Verenigde Staten, 86503
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- Chinle Center for Indigenous Health
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Chinle, Arizona, Verenigde Staten, 86503
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- Chinle Comprehensive Health Care Facility
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Sun City, Arizona, Verenigde Staten, 85351
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- Epic Medical Research-Sun City
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
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- Applied Research Center of Arkansas
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California
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Daly City, California, Verenigde Staten, 94015
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- Kaiser Permanente Daly City
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Los Angeles, California, Verenigde Staten, 90027
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- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Verenigde Staten, 90027
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- Kaiser Permanente Oncology Pharmacy #014C
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Mather, California, Verenigde Staten, 95655
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- Sacramento VA Medical Center
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Oakland, California, Verenigde Staten, 94611
- Werving
- Kaiser Permanente Oakland
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Ontario, California, Verenigde Staten, 91761
- Werving
- Kaiser Permanente Ontario Medical Center
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Roseville, California, Verenigde Staten, 95661
- Werving
- Kaiser Permanente Roseville
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Sacramento, California, Verenigde Staten, 95815
- Werving
- Kaiser Permanente Sacramento
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Sacramento, California, Verenigde Staten, 95823
- Werving
- Kaiser Permanente South Sacramento
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San Bernardino, California, Verenigde Staten, 92408
- Werving
- Velocity Clinical Research, San Bernardino
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San Diego, California, Verenigde Staten, 92123
- Werving
- Kaiser Permanente - San Diego Medical Center
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San Diego, California, Verenigde Staten, 92123
- Werving
- Kaiser Permanente Viewridge Medical Office
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San Jose, California, Verenigde Staten, 95119
- Werving
- Kaiser Permanente San Jose
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San Mateo, California, Verenigde Staten, 94403
- Actief, niet wervend
- Carbon Health - San Mateo - Hillsdale Mall
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Santa Clara, California, Verenigde Staten, 95051
- Werving
- Kaiser Permanente Santa Clara
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Toluca Lake, California, Verenigde Staten, 91602
- Werving
- Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
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Walnut Creek, California, Verenigde Staten, 94598
- Werving
- Diablo Clinical Research, Inc.
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Walnut Creek, California, Verenigde Staten, 94596
- Werving
- Kaiser Permanente Walnut Creek
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20037
- Werving
- GW Vaccine Research Unit
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Washington D.C., District of Columbia, Verenigde Staten, 20037
- Werving
- The GW Medical Faculty Associates
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Florida
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Bay Pines, Florida, Verenigde Staten, 33744
- Werving
- Bay Pines VA Healthcare System
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Fort Lauderdale, Florida, Verenigde Staten, 33308
- Werving
- Proactive Clinical Research,LLC
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Jacksonville, Florida, Verenigde Staten, 32256
- Werving
- Clinical Neuroscience Solutions, LLC
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Lake City, Florida, Verenigde Staten, 32055
- Werving
- M3 Wake Research - Lake City
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Medley, Florida, Verenigde Staten, 33166
- Werving
- South Florida Research Organization
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Miami, Florida, Verenigde Staten, 33176
- Werving
- Entrust Clinical Research
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Miami, Florida, Verenigde Staten, 33130
- Werving
- Care Research Inc
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Miami Lakes, Florida, Verenigde Staten, 33014
- Werving
- Charisma Medical and Research Center
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Miami Lakes, Florida, Verenigde Staten, 33014
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- Palm Springs Community Health Center
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Miami Lakes, Florida, Verenigde Staten, 33016
- Werving
- Indago Research & Health Center, Inc
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Tampa, Florida, Verenigde Staten, 33614
- Werving
- Angels Clinical Research Institute
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Werving
- Emory Steiner Building Research Center
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Atlanta, Georgia, Verenigde Staten, 30303
- Werving
- Emory University Woodruff Extension Building (WEB)
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Columbus, Georgia, Verenigde Staten, 31904
- Werving
- Centricity Research Columbus Georgia Multispecialty
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Decatur, Georgia, Verenigde Staten, 30033
- Werving
- Atlanta VA Medical Center
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Decatur, Georgia, Verenigde Staten, 30030
- Werving
- The Hope Clinic of Emory University
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Savannah, Georgia, Verenigde Staten, 31406
- Werving
- Velocity Clinical Research, Savannah
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Illinois
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Melrose Park, Illinois, Verenigde Staten, 60160
- Werving
- DM Clinical Research - Chicago
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
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- McFarland Clinic, PC
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Ames, Iowa, Verenigde Staten, 50010
- Werving
- Accellacare - McFarland
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Sioux City, Iowa, Verenigde Staten, 51106
- Werving
- Velocity Clinical Research, Sioux City
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Kansas
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Newton, Kansas, Verenigde Staten, 67114
- Werving
- AMR Clinical
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70836
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- Ochsner Medical Complex - The Grove
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Kenner, Louisiana, Verenigde Staten, 70065
- Werving
- Ochsner Clinic Foundation - Kenner Clinical Trials Unit
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Lafayette, Louisiana, Verenigde Staten, 70503
- Werving
- Ochsner Lafayette General Medical Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21205
- Werving
- Johns Hopkins Bloomberg School of Public Health
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Baltimore, Maryland, Verenigde Staten, 21231
- Werving
- Johns Hopkins Bloomberg School of Public Health
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Massachusetts
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West Roxbury, Massachusetts, Verenigde Staten, 02132
- Werving
- VA Boston Healthcare System - West Roxbury
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Michigan
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Southfield, Michigan, Verenigde Staten, 48076
- Werving
- DM Clinical Research - Detroit
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Southfield, Michigan, Verenigde Staten, 48075
- Werving
- Revive Research Institute, Inc.
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University School of Medicine
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St Louis, Missouri, Verenigde Staten, 63141
- Werving
- Sundance Clinical Research
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Nebraska
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Grand Island, Nebraska, Verenigde Staten, 68803
- Werving
- Velocity Clinical Research, Grand Island
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Omaha, Nebraska, Verenigde Staten, 68105
- Werving
- University of Nebraska Medical Center
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Omaha, Nebraska, Verenigde Staten, 68134
- Werving
- Velocity Clinical Research, Omaha
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Omaha, Nebraska, Verenigde Staten, 68198
- Werving
- University Of Nebraska Medical Center
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
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- Renown Regional Medical Center
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Reno, Nevada, Verenigde Staten, 89502
- Werving
- Renown Center for Advanced Medicine
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Reno, Nevada, Verenigde Staten, 89519
- Werving
- University Health
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- HMH Hackensack University Medical Center
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- Hackensack Meridian Health Hackensack University Medical Center
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Hackensack, New Jersey, Verenigde Staten, 07601
- Werving
- HMH David Jurist Research Building
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Neptune City, New Jersey, Verenigde Staten, 07753
- Werving
- Hackensack Meridian Health Jersey Shore University Medical Center
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Neptune City, New Jersey, Verenigde Staten, 07753
- Werving
- HOPE Tower at Jersey Shore University Medical Center
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New Brunswick, New Jersey, Verenigde Staten, 08901
- Werving
- Rutgers Robert Wood Johnson Medical School
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Somers Point, New Jersey, Verenigde Staten, 08244
- Werving
- South Jersey Infectious Disease
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- Werving
- Albuquerque Clinical Trials, Inc.
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Gallup, New Mexico, Verenigde Staten, 87301
- Werving
- Gallup Center for Indigenous Health
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Gallup, New Mexico, Verenigde Staten, 87301
- Werving
- Gallup Indian Medical Center
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Shiprock, New Mexico, Verenigde Staten, 87420
- Werving
- Shiprock Center for Indigenous Health
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Shiprock, New Mexico, Verenigde Staten, 87420
- Werving
- Northern Navajo Medical Center
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New York
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Brooklyn, New York, Verenigde Staten, 11220
- Werving
- NYU Langone Health
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East Syracuse, New York, Verenigde Staten, 13057
- Werving
- Upstate Global Health Institute
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Long Island City, New York, Verenigde Staten, 11102
- Werving
- Mount Sinai Queens
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Manhasset, New York, Verenigde Staten, 11030
- Werving
- North Shore University Hospital
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Manhasset, New York, Verenigde Staten, 11030
- Werving
- Northwell Health Infectious Disease
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Mineola, New York, Verenigde Staten, 11501
- Werving
- NYU Langone Health
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Mount Kisco, New York, Verenigde Staten, 10549
- Werving
- Northern Westchester Hospital
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New York, New York, Verenigde Staten, 10016
- Werving
- NYU Langone Health
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University Irving Medical Center
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New York, New York, Verenigde Staten, 10029
- Werving
- Icahn School of Medicine at Mount Sinai
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New York, New York, Verenigde Staten, 10019
- Werving
- Mount Sinai West
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New York, New York, Verenigde Staten, 10025
- Werving
- Mount Sinai Morningside
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Rochester, New York, Verenigde Staten, 14609
- Werving
- Rochester Clinical Research, LLC
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Sleepy Hollow, New York, Verenigde Staten, 10591
- Werving
- Phelps Hospital Geriatric Medicine & Improvement Science
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Staten Island, New York, Verenigde Staten, 10305
- Werving
- Staten Island University Hospital
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The Bronx, New York, Verenigde Staten, 10468
- Werving
- James J. Peters VA Medical Center
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The Bronx, New York, Verenigde Staten, 10467
- Werving
- Montefiore Medical Center
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North Carolina
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Cary, North Carolina, Verenigde Staten, 27518
- Werving
- Accellacare - Cary
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Durham, North Carolina, Verenigde Staten, 27703
- Werving
- Duke Vaccine and Trials Unit
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Greensboro, North Carolina, Verenigde Staten, 27401
- Werving
- Medication Management
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Hickory, North Carolina, Verenigde Staten, 28601
- Werving
- Accellacare - Hickory
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High Point, North Carolina, Verenigde Staten, 27262
- Werving
- Atrium Health Wake Forest Baptist Infectious Disease-High Point
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Accellacare - Raleigh
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Duke University Health System
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Raleigh Medical Group P.A.
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Duke University Health System-Duke Vaccine and Trials Unit Raleigh
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Salisbury, North Carolina, Verenigde Staten, 28144
- Werving
- Accellacare - Salisbury
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Wilmington, North Carolina, Verenigde Staten, 28401
- Werving
- Accellacare - Wilmington
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Wilmington, North Carolina, Verenigde Staten, 28401
- Werving
- Wilmington Health, PLLC
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Werving
- Wake Forest Baptist Health
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Winston-Salem, North Carolina, Verenigde Staten, 27103
- Werving
- Accellacare - Winston-Salem
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45212
- Werving
- CTI Clinical Research Center
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Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- VA Northeast Ohio Healthcare System Louis Stokes Cleveland VA Medical Center
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Oregon
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Portland, Oregon, Verenigde Staten, 97227
- Werving
- Kaiser Permanente Center for Health Research
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Pennsylvania
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Camp Hill, Pennsylvania, Verenigde Staten, 17011
- Werving
- Capital Area Research, LLC
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Werving
- DM Clinical Research - Philadelphia
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South Carolina
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Little River, South Carolina, Verenigde Staten, 29566
- Werving
- Walker Family Care
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Werving
- Velocity Clinical Research, Spartanburg
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37909
- Werving
- New Phase Research and Development
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Memphis, Tennessee, Verenigde Staten, 38119
- Werving
- Clinical Neuroscience Solutions, LLC
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Nashville, Tennessee, Verenigde Staten, 37232
- Werving
- Vanderbilt University Medical Center
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Nashville, Tennessee, Verenigde Staten, 37212
- Werving
- The Vanderbilt Vaccine Research Program Clinic at The Village at Vanderbilt
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Nashville, Tennessee, Verenigde Staten, 37232
- Werving
- Vanderbilt Investigational Drug Service (IDS)
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Nashville, Tennessee, Verenigde Staten, 37232
- Werving
- Vanderbilt Vaccine Research Program Laboratory
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Nashville, Tennessee, Verenigde Staten, 37232
- Werving
- Vanderbilt Vaccine Research Program
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Texas
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Dallas, Texas, Verenigde Staten, 75246
- Werving
- North Texas Infectious Diseases Consultants, P.A
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Dallas, Texas, Verenigde Staten, 75237
- Werving
- Family Health Watch - KeyPoint Clinical Research
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Dallas, Texas, Verenigde Staten, 75240
- Werving
- KeyPoint Clinical Research
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Euless, Texas, Verenigde Staten, 76040
- Werving
- Cedar Health Research - Euless
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Houston, Texas, Verenigde Staten, 77030
- Werving
- Baylor College of Medicine
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Houston, Texas, Verenigde Staten, 77030
- Werving
- The University of Texas Health Science Center at Houston
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Houston, Texas, Verenigde Staten, 77065
- Werving
- DM Clinical Research- Cyfair
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Houston, Texas, Verenigde Staten, 77087
- Werving
- Mercury Clinical Research - Santa Clara Family Clinic
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Houston, Texas, Verenigde Staten, 77030
- Werving
- UT Physicians
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Houston, Texas, Verenigde Staten, 77030
- Werving
- Memorial Hermann Hospital - TMC
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Tomball, Texas, Verenigde Staten, 77375
- Werving
- Northwest Houston Heart Center
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Tomball, Texas, Verenigde Staten, 77375
- Werving
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84121
- Werving
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401
- Werving
- The University of Vermont Medical Center Inc.
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Burlington, Vermont, Verenigde Staten, 05401
- Werving
- UVM Larner College of Medicine MMG/VCT
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Virginia
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Richmond, Virginia, Verenigde Staten, 23226
- Werving
- Clinical Research Partners, LLC
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Washington
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Everett, Washington, Verenigde Staten, 98201
- Werving
- Providence Regional Medical Center Everett
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Seattle, Washington, Verenigde Staten, 98104
- Werving
- University of Washington - Harborview Medical Center
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Seattle, Washington, Verenigde Staten, 98101
- Werving
- Kaiser Permanente Washington Health Research Institute (KPWHRI)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
65 jaar en ouder (Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Zoutoplossing placebo
|
0.9% sodium chloride solution given as a intramuscular injection |
|
Experimenteel: C.difficile vaccine
Novel vaccine formulation |
C.difficile vaccine given as an intramuscular injection |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The percentage of participants reporting local reactions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The incidence of antibiotic use in the treatment of a first episode of the primary CDI
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 december 2025
Primaire voltooiing (Geschat)
11 december 2028
Studie voltooiing (Geschat)
7 juni 2029
Studieregistratiedata
Eerst ingediend
5 december 2025
Eerst ingediend dat voldeed aan de QC-criteria
5 december 2025
Eerst geplaatst (Werkelijk)
15 december 2025
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 november 2026
Laatste update ingediend die voldeed aan QC-criteria
4 november 2026
Laatst geverifieerd
1 november 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- C4771002
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .