Clostridium Difficile Vaccine Efficacy Trial (Clover)

January 17, 2023 updated by: Pfizer

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17535

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000JRD
        • Hospital Nuestra Senora de la Misericordia
    • Buenos Aires
      • C.a.b.a., Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
      • C.a.b.a., Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • C.a.b.a., Buenos Aires, Argentina, C1426ABP
        • Centro Médico Dra. De Salvo
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000CVB
        • Sanatorio Britanico S.A.
  • Australia
      • Maroubra, Australia, 2035
        • Australian Clinical Research Network
    • New South Wales
      • Kanwal, New South Wales, Australia, 2259
        • Paratus Clinical Pty Ltd
      • Maroiubra, New South Wales, Australia, 2035
        • Australian Clinical Research Network
      • Maroubra, New South Wales, Australia, 2035
        • Maroubra MEdical Centre
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
      • Westmead, New South Wales, Australia, 2145
        • University Clinic Pharmacy
    • Queensland
      • Sherwood, Queensland, Australia, 4075
        • AusTrials Pty Ltd
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd & Mater Medical Research Institute Ltd
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health - Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liege, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Bulgaria
      • Kazanlak, Bulgaria, 6100
        • "MHAT- Dr. Hristo Stambolski" EOOD
      • Kozloduy, Bulgaria, 3320
        • MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department
      • Lom, Bulgaria, 3600
        • MHAT "Sv. Nikolay Chudotvorets" EOOD
      • Pleven, Bulgaria, 5800
        • UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sveti Georgi" EAD
      • Ruse, Bulgaria, 7000
        • "Center for Mental Health - Ruse" EOOD
      • Ruse, Bulgaria, 7002
        • SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
      • Sevlievo, Bulgaria, 5400
        • ''Medical Center-1-Sevlievo'' EOOD
      • Silistra, Bulgaria, 7500
        • MHAT -Silistra AD
      • Sliven, Bulgaria, 8800
        • MC ''Tsaritsa Yoanna''EOOD
      • Sofia, Bulgaria, 1142
        • MC 'Cardiohelp' EOOD
      • Sofia, Bulgaria, 1407
        • "Acibadem City Clinic University Hospital" EOOD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Ead
      • Sofia, Bulgaria, 1750
        • MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases
      • Troyan, Bulgaria, 5600
        • "SHATPD-Troyan" EOOD
      • Veliko Tarnovo, Bulgaria, 5000
        • MC Medica Plus OOD
      • Vidin, Bulgaria, 3700
        • MHAT ''Sveta Petka" AD
  • Canada
      • Quebec, Canada, G3K 2P8
        • Alpha Recherche Clinique
      • Quebec, Canada, G1E7G9
        • Centre de recherche du CHU de Québec-Université Laval
      • Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital General Campus
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital Civic Campus
      • Toronto, Ontario, Canada, M9W4L6
        • Manna Research Inc. (Toronto)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7Y8
        • Intermed groupe santé
      • Gatineau, Quebec, Canada, J8Y 6S8
        • Q & T Research Outaouais Inc.
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne
      • Sherbrooke, Quebec, Canada, J1H5N4
        • CIUSSS de l'Estrie - CHUS
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
  • Chile
    • IX Region DE LA Araucania
      • Temuco, IX Region DE LA Araucania, Chile, 4781156
        • Centro de Investigacion Clinica del Sur
    • Region DE Antofagasta
      • Antofagasta, Region DE Antofagasta, Chile, 1270244
        • Psicomed Esudios Medicos
    • Region DE LA Araucania
      • Temuco, Region DE LA Araucania, Chile, 4781151
        • Hospital Dr. Hernan Henriquez Aravena
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7500710
        • Biomedica Research Group
      • Santiago, Región Metropolitana, Chile, 8360159
        • Fundacion Arriaran
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050001
        • Hospital Pablo Tobon Uribe
      • Medellin, Antioquia, Colombia, 050021
        • Fundacion Centro de Investigacion Clinica - CIC
      • Medellin, Antioquia, Colombia, 050025
        • Instituto de Coloproctologia ICO
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clínica de la Costa Ltda.
    • Caldas
      • Manizales, Caldas, Colombia, 170004
        • Asociacion IPS Medicos Internistas de Caldas
    • D.c.
      • Bogota, D.c., Colombia, 110221
        • Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.
    • Quindío
      • Armenia, Quindío, Colombia, 630004
        • Fundacion Cardiomet CEQUIN
    • Santander
      • Floridablanca, Santander, Colombia, 681002
        • Fundacion Cardiovascular de Colombia
    • Valle DEL Cauca
      • Cali, Valle DEL Cauca, Colombia, 760032
        • Fundacion Valle del Lili
      • Cali, Valle DEL Cauca, Colombia, 760043
        • Centro Medico Imbanaco de Cali S.A.
  • Czechia
      • Benatky nad Jizerou, Czechia, 29471
        • Ordinace vseobecneho praktickeho lekare
      • Kyjov, Czechia, 697 01
        • Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni
      • Opava, Czechia, 74601
        • Slezska Nemocnice v Opave, prispevkova organizace
      • Policka, Czechia, 572 01
        • Policska nemocnice s.r.o.,
      • Praha 5, Czechia, 15006
        • Fakultni Nemocnice V Motole
      • Pribram I., Czechia, 26101
        • Oblastní nemocnice Příbram, a.s.
      • Roznov pod Radhostem, Czechia, 756 61
        • Interna a kardiologie s.r.o.
      • Slany, Czechia, 274 01
        • Nemocnice Slany, p.o.
      • Slany, Czechia, 27401
        • Sarkamed s.r.o.
      • Usti nad Labem, Czechia, 401 13
        • Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem
    • Czech
      • Brno, Czech, Czechia, 65622
        • Doktor Brno s.r.o.
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Helsinki University Central Hospital
      • Kokkola, Finland, 67100
        • Kokkola Vaccine Research Clinic
      • Oulu, Finland, 90220
        • Oulu Vaccine Research Clinic
      • Pori, Finland, 28100
        • Pori Vaccine Research Clinic
      • Tampere, Finland, 33100
        • Tampere Vaccine Research Clinic
      • Turku, Finland, 20520
        • Turku Vaccine Research Clinic
  • France
      • Dijon cedex, France, 21079
        • CHU Dijon Bourgogne- Hopital Francois Mitterrand
      • Paris, France, 75014
        • CIC Vaccinologie Cochin- Pasteur 1417
      • Saint Priest en Jarez, France, 42270
        • Hôpital Nord-CHU Saint Etienne
      • Tours Cedex 09, France, 37044
        • CHRU de Tours- Hopital Bretonneau
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH
      • Cottbus, Germany, 03050
        • MECS Cottbus GmbH
      • Dresden, Germany, 01279
        • Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen, Klinik fuer Infektiologie
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH/ Praxis
      • Leipzig, Germany, 04103
        • SIBAmed Studienzentrum GmbH & Co.KG
      • Leipzig, Germany, 04249
        • Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut
      • Rostock, Germany, 18057
        • Universitaetsmedizin Rostock
      • Westerstede, Germany, 26655
        • Praxis Dr. med. J. Springub/ W. Schwarz
      • Westerstede, Germany, 26655
        • Studienzentrum Nordwest
      • Wuerzburg, Germany, 97070
        • Klinikum Wuerzburg Mitte gGmbH
  • Hungary
      • Baja, Hungary, 6500
        • Bajai Szent Rokus Korhaz, II Belgyogyaszat
      • Balatonfured, Hungary, 8230
        • DRC Kft.
      • Budapest, Hungary, 1021
        • Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika
      • Debrecen, Hungary, 4031
        • ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
      • Encs, Hungary, 3860
        • CRU Hungary Kft.
      • Kaposvar, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly
  • Japan
      • Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Kumamoto, Japan, 861-8520
        • Japanese Red Cross Kumamoto Hospital
      • Saga, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
    • Aichi
      • Kasugai, Aichi, Japan, 487-0031
        • Tokai Memorial Hospital
      • Nagakute, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nagoya, Aichi, Japan, 457-8511
        • Daido Clinic
      • Nagoya, Aichi, Japan, 462-0802
        • Kamiiida Daiichi General Hospital
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
        • Iizuka Hospital
      • Itoshima, Fukuoka, Japan, 819-1104
        • Seishinkai Inoue Hospital
      • Kasuga, Fukuoka, Japan, 816-0864
        • Fukuoka Tokushukai Hospital
      • Kitakyushu, Fukuoka, Japan, 803-8543
        • Kenwakai Otemachi Hospital
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 721-8511
        • Fukuyama City Hospital
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 064-8570
        • Miyanomori Memorial Hospital
    • Ibaraki
      • Koga, Ibaraki, Japan, 306-0041
        • Medical Corporation Tokushukai Koga General Hospital
      • Mito, Ibaraki, Japan, 310-0015
        • Mito Kyodo General Hospital
    • Kanagawa
      • Yokosuka, Kanagawa, Japan, 238-8558
        • Yokosuka Kyosai Hospital
    • Miyagi
      • Osaki, Miyagi, Japan, 989-6183
        • Osaki Citizen Hospital
    • Nagano Prefecture
      • Matsumoto-City, Nagano Prefecture, Japan, 390-8601
        • Social Medical Care Corporation Hose-kai Marunouchi Hospital
    • Osaka
      • Daito, Osaka, Japan, 547-0074
        • Nozaki Tokushukai Hospital
    • Shiga
      • Kusatsu, Shiga, Japan, 525-8585
        • Omi Medical Center
    • Shizuoka
      • Yaizu, Shizuoka, Japan, 425-8505
        • Yaizu City Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Nerima-ku, Tokyo, Japan, 176-8530
        • Nerima General Hospital
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Sekino Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05355
        • Hallym University Kangdong Sacred Heart Hospital
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
    • Seoul
      • Songpa-gu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Peru
      • Cusco, Peru, 08002
        • Hospital Nacional Adolfo Guevara Velasco
      • Lima, Peru, 41
        • Clinica Internacional S.A
      • Trujillo, La Libertad, Peru, 13011
        • Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A
    • Lima
      • San Martin de Porres, Lima, Peru, 31
        • Hospital Cayetano Heredia
  • Poland
      • Bydgoszcz, Poland, 85-079
        • NZOZ Vitamed
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o Oddzial w Gdansku
      • Gdynia, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Katowice, Poland, 40-040
        • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
      • Leczna, Poland, 21-010
        • Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
      • Poznan, Poland, 60-702
        • Synexus Polska Sp. z o.o. Oddział w Poznaniu
      • Warszawa, Poland, 01-192
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Wroclaw, Poland, 50-381
        • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Aveiro, Portugal, 3814-501
        • Centro Hospitalar do Baixo Vouga, E.P.E.
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Guimaraes, Portugal, 4835-044
        • Hospital Senhora de Oliveira - Guimaraes, E.P.E.
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
  • Slovakia
      • Bojnice, Slovakia, 972 01
        • PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia
      • Bratislava, Slovakia, 851 01
        • Medak s.r.o., Gastroenterologicka ambulancia
      • Kosice, Slovakia, 040 22
        • Stalerg, s.r.o.
      • Nitra, Slovakia, 949 01
        • KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
      • Nove Zamky, Slovakia, 940 01
        • Dionea, s.r.o.
      • Piestany, Slovakia, 921 01
        • MEDIPA, s.r.o.
      • Pruske, Slovakia, 01852
        • MUDr. Viliam Cibik, PhD, s.r.o.
      • Rimavska Sobota, Slovakia, 979 01
        • Medilex s.r.o., Interna ambulancia
      • Spisska Nova Ves, Slovakia, 052 01
        • Plucna ambulancia Hrebenar s.r.o.
      • Stara Tura, Slovakia, 916 01
        • SPAOLO s.r.o., Ambulancia vnutorneho lekarstva
      • Trencin, Slovakia, 911 01
        • Privatna urologicka ambulancia, s.r.o.
      • Trencin, Slovakia, 91101
        • MUDr. Zakova, s.r.o.
      • Trnava, Slovakia, 917 75
        • Fakutna nemocnica Trnava
  • Spain
      • A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08003
        • Parc de Salut Mar- Hospital del Mar
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Barcelona
      • Centelles, Barcelona, Spain, 08540
        • EAP Centelles
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
  • Sweden
      • Eskilstuna, Sweden, 63188
        • Infektionskliniken, Malarsjukhuset
      • Goteborg, Sweden, 41650
        • Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset
      • Göteborg, Sweden, 41345
        • Gothia Forum CTC/Sahlgrenska Universitetssjukhuset
      • Orebro, Sweden, 70362
        • Avdelningen for kliniska provningar, S-huset
      • Stockholm, Sweden, 11324
        • Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
    • Taiwan (r.o.c.)
      • Kaohsiung City, Taiwan (r.o.c.), Taiwan, 81362
        • Kaohsiung Veterans General Hospital
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Newcastle Upon Tyne Hospitals NHS Foundation Trust
    • Cheshire
      • Stockport, Cheshire, United Kingdom, SK27JE
        • Stockport NHS Foundation Trust
    • Cornwall
      • Fowey, Cornwall, United Kingdom, PL23 1DT
        • Fowey River Practice
      • Liskeard, Cornwall, United Kingdom, PL14 3XA
        • Oak Tree Surgery
      • Penzance, Cornwall, United Kingdom, TR183DX
        • The Alverton Practise, St Clare Medical Centre
      • Torpoint, Cornwall, United Kingdom, PL11 2TB
        • Rame Group Practice, Rame Medical Ltd.
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
      • Plymouth, Devon, United Kingdom, PL5 3JB
        • Knowle House Surgery
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Layton Medical Centre
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • NHS Lothian, Western General Hospital
    • WEST Midlands
      • Birmingham, WEST Midlands, United Kingdom, B9 5SS
        • Heart of England NHS Foundation Trust
  • United States
    • Alabama
      • Athens, Alabama, United States, 35611
        • North Alabama Research Center, LLC
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, LLC, An AMR Company
    • Arizona
      • Peoria, Arizona, United States, 85381
        • The Pain Center of Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System
      • Phoenix, Arizona, United States, 85014
        • Phoenix Clinical LLC
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC
      • Phoenix, Arizona, United States, 85018
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85018
        • The Pain Center of Arizona
      • Surprise, Arizona, United States, 85374
        • Clinical Research Institute of Arizona, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center for Clinical Research
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Rehabilitation Institute
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Covina, California, United States, 91723
        • California Kidney Specialist
      • Covina, California, United States, 91724
        • Usborne Family Medicine
      • Daly City, California, United States, 94015
        • Kaiser Permanente Daly City
      • Downey, California, United States, 90241
        • Premier Health Research Center, LLC
      • La Mesa, California, United States, 91942
        • Paradigm Clinical Research Centers, Inc.
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System Research Pharmacy
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc.
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90095
        • UCLA CTRC Outpatient Unit
      • Mather, California, United States, 95655
        • VA Northern California Health Care System
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto Health Care System
      • Rancho Mirage, California, United States, 92270
        • Covigilant Research, LLC
      • Redding, California, United States, 96001
        • Paradigm Clinical Research Centers, Inc.
      • Redlands, California, United States, 92373
        • VA Loma Linda Healthcare System Ambulatory Care System
      • Riverside, California, United States, 92506
        • Covigilant Research LLC
      • Roseville, California, United States, 95661
        • Kaiser Permanente Roseville
      • Sacramento, California, United States, 95823
        • Kaiser Permanente South Sacramento
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
      • Sacramento, California, United States, 95811
        • One Community Health
      • Sacramento, California, United States, 95815
        • Kaiser Permanente Sacramento
      • Sacramento, California, United States, 95817
        • CTSC Clinical Research Center
      • Sacramento, California, United States, 95817
        • Lawrence J. Ellison Ambulatory Care Center
      • San Bernardino, California, United States, 92408
        • Breakthrough Clinical Trials
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System
      • San Dimas, California, United States, 91773
        • California Kidney Specialists
      • San Jose, California, United States, 95119
        • Kaiser Permanente San Jose
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Santa Clara
      • Simi Valley, California, United States, 93065
        • Alta California Medical Group
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Clinical Trial Center University of Colorado Denver, School of Medicine
      • Aurora, Colorado, United States, 80045
        • University of Colorado Clinical & Translational Research Center Clinic
      • Aurora, Colorado, United States, 80045
        • University of Colorado Clinical & Translational Research Center Outpatient Clinic
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, School of Medicine
      • Aurora, Colorado, United States, 80045
        • University of Colorado Department of AIP 2. Pharmacy Bulk Storage
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
      • Hamden, Connecticut, United States, 06518
        • Gastroenterology Center of Connecticut, PC
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting, LLC
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Brandon, Florida, United States, 33511
        • Florida Sleep Disorder Center of Brandon
      • Brandon, Florida, United States, 33511
        • Teradan Clinical Trials
      • Chiefland, Florida, United States, 32626
        • Southeast Clinical Research
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West FL., Inc.
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Reseach, LLC
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants, LLC
      • DeLand, Florida, United States, 32720
        • Accel Research Sites - DeLand Clinical Research Unit
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center for Clinical Research
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center Investigational Drug Services
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions,Inc.
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33125
        • Optimus U. Corp.
      • Miami, Florida, United States, 33135
        • Doctors Research Institute
      • Miami, Florida, United States, 33142
        • Acevedo Clinical Research Associates
      • Miami, Florida, United States, 33144
        • Next Phase Research Alliance
      • Miami Lakes, Florida, United States, 33014
        • Charisma Medical and Research Center
      • Miami Springs, Florida, United States, 33166
        • Ocean Blue Medical Research Center, Inc.
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Orlando, Florida, United States, 32819
        • HMD Research LLC
      • Pembroke Pines, Florida, United States, 33026
        • Pines Care Research Center, LLC
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research, LLC
      • West Palm Beach, Florida, United States, 33406
        • Soma Medical Center
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Champaign, Illinois, United States, 61822
        • Christie Clinic, LLC
      • Hines, Illinois, United States, 60141
        • Edward Hines Jr VA Hospital
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic Infectious Diseases
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Clinical Research Center
      • Carmel, Indiana, United States, 46032
        • Infectious Disease Of Indiana, Psc
      • Carmel, Indiana, United States, 46032
        • St. Vincent Outpatient Treatment Center
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinic Mt. Pleasant
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital and Health Care Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital & Health Care Center
      • Mishawaka, Indiana, United States, 46544
        • MOC Research
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Meridian Clinical Research
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, LLC
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research, LLC
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
      • Natchitoches, Louisiana, United States, 71457
        • Barnum Medical Research Inc
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Center for Primary Care and Wellness
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Anne Arundel Medical Center Infusion Center
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Anne Arundel Medical Center
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Research Institute: Research Office
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System
      • Canton, Michigan, United States, 48187
        • ClinSite, LLC
      • Flint, Michigan, United States, 48504
        • Aa Mrc Llc
      • Sterling Heights, Michigan, United States, 48313
        • Revival Research Institute, LLC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester, Methodist Hospital Campus
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • MedPharmics
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63108
        • Center for Outpatient Health
      • Saint Louis, Missouri, United States, 63110-1093
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Center for Advanced Medicine
      • Saint Louis, Missouri, United States, 63110
        • Center For Clinical Studies
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
      • Bozeman, Montana, United States, 59715
        • Bozeman Health GI Clinic
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68128
        • Barrett Clinic
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
      • Raritan, New Jersey, United States, 08869
        • Amici Clinical Research
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Disease
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • New Mexico VA Healthcare System
    • New York
      • Binghamton, New York, United States, 13901
        • Meridian Clinical Research LLC
      • Endwell, New York, United States, 13760
        • Meridian Clinical Research, LLC
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte, LLC
      • Durham, North Carolina, United States, 27705
        • Durham VAMC
      • Durham, North Carolina, United States, 27710
        • Duke Early Phase Clinical Research
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital Investigational Drug Services (IDS) Pharmacy
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory, LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh, LLC
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury, LLC
      • Tabor City, North Carolina, United States, 28463
        • Waterway Primary Care LLC DBA Tabor City Family Medicine
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Progressive Medicine of the Triad, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Canton, Ohio, United States, 44710
        • Aultman Cardiology Clinical Trials
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, United States, 45219
        • UC Health Physicians Office Clifton
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Group, Ltd.
      • Cincinnati, Ohio, United States, 45267
        • University Of Cincinnati-Internal Medicine Division of Digestive Diseases
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes Cleveland VA Medical Center
      • Cleveland, Ohio, United States, 44122
        • Velocity Clinical Research, Inc.
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43214
        • OhioHealth Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Incorporated
      • Dayton, Ohio, United States, 45419
        • PriMed Clinical Research
      • Mentor, Ohio, United States, 44060
        • Great Lakes Medical Research LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
      • Portland, Oregon, United States, 97239
        • Columbia Research Group, Inc.
      • Portland, Oregon, United States, 97239
        • VA Portland Healthcare System
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network/Network Office of Research and Innovation
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
      • Erie, Pennsylvania, United States, 16506
        • Westminster Family Medicine
      • Erie, Pennsylvania, United States, 16508
        • Liberty Family Practice
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians, Inc.
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians, Inc.
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research, Providence
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical Research South, LLC
      • Little River, South Carolina, United States, 29566
        • Main Street Physician's Care - Waterway
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Bristol, Tennessee, United States, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC
      • Knoxville, Tennessee, United States, 37912
        • PMG Research, Inc. d/b/a PMG Research of Knoxville
      • Knoxville, Tennessee, United States, 37938
        • PMG Research,Inc. d/b/a PMG Research of Knoxville
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
      • Tullahoma, Tennessee, United States, 37388
        • Trinity Clinical Research
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc.
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A.
      • Dallas, Texas, United States, 75324
        • Synexus US, LP
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group, LLC
      • Fort Worth, Texas, United States, 76104
        • Texas Health Care, PLLC
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center at Fort Worth
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77025
        • Kelsey Research Foundation
      • Houston, Texas, United States, 77025
        • Kelsey-Seybold Clinic
      • Mesquite, Texas, United States, 75149
        • Synexus US, dba Research Across America
      • Pearland, Texas, United States, 77584
        • Linq Research, Llc
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Healthcare System, Audie L Murphy Hospital
      • Tomball, Texas, United States, 77375
        • Martin Diagnostic Clinic
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
    • Utah
      • Draper, Utah, United States, 84020
        • J. Lewis Research Inc. / Foothill Family Clinic Draper
      • Riverton, Utah, United States, 84065
        • Advanced Clinical Research/Gut Whisperer
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc./Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J Lewis Research, Incorporated
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc. - Jordan River Family Medicine
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Clinical Alliance for Research & Education - Infectious Diseases, LLC
      • Midlothian, Virginia, United States, 23114
        • Virginia Research Center LLC
      • Salem, Virginia, United States, 24153
        • Salem VAMC
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Frandsen Family Medicine DBA Sound Medical Research
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
      • Tacoma, Washington, United States, 98405
        • Universal Research Group, LLC
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center - Marshfield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document.
  • Willing and able to comply with study procedures.
  • Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
  • Ability to be contacted by telephone during study participation.
  • Negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
  • Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
  • Prior episode of CDI..
  • Receipt of blood products or immunoglobulins within 6 months before enrollment.

  • Subjects who may be unable to respond to vaccination due to:

    • Metastatic malignancy; or
    • End-stage renal disease; or
    • Any serious medical disorder likely to be fatal within the next 12 months; or
    • Congenital or acquired immunodeficiency; or
    • Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
    • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
  • Known infection with human immunodeficiency virus (HIV).
  • Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Prior small- or large-bowel resection.
  • Any condition or treatment resulting in frequent diarrhea.
  • Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
  • Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Biological: Placebo
Normal saline solution (0.9% sodium chloride)
EXPERIMENTAL: Clostridium difficile vaccine
Biological: Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3
Time Frame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by polymerase chain reaction [PCR)] and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2
Time Frame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1
Time Frame: Within 7 days after Dose 1 at Month 0
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Within 7 days after Dose 1 at Month 0
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2
Time Frame: Within 7 days after Dose 2 at Month 1
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Within 7 days after Dose 2 at Month 1
Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3
Time Frame: Within 7 days after Dose 3 at Month 6
Local reactions included redness, swelling and pain at injection site. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: >10.0 cm. Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity. Grade 4 indicated emergency room visit or hospitalization.
Within 7 days after Dose 3 at Month 6
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1
Time Frame: Within 7 days after Dose 1 at Month 0
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius [deg C]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Within 7 days after Dose 1 at Month 0
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2
Time Frame: Within 7 days after Dose 2 at Month 1
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Within 7 days after Dose 2 at Month 1
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3
Time Frame: Within 7 days after Dose 3 at Month 6
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), potentially life threatening (> 40.0 deg C). Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock.
Within 7 days after Dose 3 at Month 6
Number of Participants Reporting Adverse Events (AEs)
Time Frame: From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. AEs included both SAEs and all Non-SAEs (except local and systemic events).
From Day 1 of Dose 1 to 1 Month after Dose 3 (7 Months)
Number of Participants Reporting Serious Adverse Events (SAEs)
Time Frame: From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)
An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
From Day 1 of Dose 1 up to 6 months after Dose 3 (up to Month 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of All Episodes of CDI (Definition 1 and 2) After Dose 3
Time Frame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3
Time Frame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Resolution of the event was the last day on which the event was recorded in the e-diary or the date the event ends if it was unresolved during the participant diary-recording period (end date collected on the case report form [CRF]). CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3
Time Frame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3
Time Frame: From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 3 to the end of the surveillance period (mean follow-up after dose 3 was 34.2 months)
Number of All Episodes of CDI (Definition 1 and 2) After Dose 2
Time Frame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
CDI definition 1 for primary episode of CDI (no previous CDI onset in prior 8 weeks) and CDI definition 2 for recurrent episode (episode occurred 8 weeks or less after onset of previous episode [provided symptoms of previous episode resolved]) were both defined as either a) presence of diarrhea, (passage of 3 or more unformed stools [Bristol stool chart types 5-7]) in 24 or fewer consecutive hours, stool sample positive for toxin B gene (by PCR),positive for toxin A and/or toxin B, as measured in central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, surgery, histopathologically; and corresponding stool sample positive for toxin B gene (via PCR) as measured in central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2
Time Frame: From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 2 to the end of the surveillance period (mean follow-up after dose 2 was 36 months)
Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3
Time Frame: From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
CDI definition 1 for a primary episode of CDI (no previous CDI onset in the prior 8 weeks) was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours, and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (via PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3
Time Frame: From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses
CDI definition 2 for a recurrent episode (an episode of CDI that occurred 8 weeks or less after the onset of a previous CDI episode [provided the symptoms of the previous episode had resolved]), was defined as either a) presence of diarrhea, defined as passage of 3 or more unformed stools (Bristol stool chart types 5-7) in 24 or fewer consecutive hours; and stool sample that was positive for the toxin B gene (by PCR) and positive for toxin A and/or toxin B, as measured in the central laboratory; or b) Pseudomembranous colitis diagnosed at colonoscopy, at surgery, or histopathologically; and corresponding stool sample that was positive for the toxin B gene (by PCR) as measured in the central laboratory. End of surveillance period was defined as accumulation of at least 40 CDI cases.
From 14 days after Dose 2 to Dose 3 or the day the third vaccination was expected (168 days after Dose 2) for participants who received only 2 doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2017

Primary Completion (ACTUAL)

December 21, 2021

Study Completion (ACTUAL)

December 21, 2021

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B5091007
  • 2016-003866-14 (EUDRACT_NUMBER)
  • CLOVER (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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