Clostridium Difficile Vaccine Efficacy Trial

Clostridium Difficile Infection Clinical Trial

— Clover  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090191
• Other study ID #: B5091007
• Secondary ID: 2016-003866-14CL
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2017
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17535
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections

Intervention

Biological:
• Clostridium difficile vaccine
Toxoid-based Clostridium difficile vaccine
• Placebo
Normal saline solution (0.9% sodium chloride)

Locations

Country	Name	City	State
Argentina	Centro Médico Dra. De Salvo	C.a.b.a.	Buenos Aires
Argentina	Hospital Aleman	C.a.b.a.	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	C.a.b.a.	Buenos Aires
Argentina	Hospital Nuestra Senora de la Misericordia	Cordoba
Argentina	Sanatorio Británico S.A.	Rosario	Santa FE
Australia	Eastern Health - Box Hill Hospital	Box Hill	Victoria
Australia	Emeritus Research	Camberwell	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Paratus Clinical Pty Ltd	Kanwal	New South Wales
Australia	Australian Clinical Research Network	Maroiubra	New South Wales
Australia	Australian Clinical Research Network	Maroubra
Australia	Maroubra Medical Centre	Maroubra	New South Wales
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Austrials Pty Ltd	Sherwood	Queensland
Australia	Mater Misericordiae Ltd & Mater Medical Research Institute Ltd	South Brisbane	Queensland
Australia	University Clinic Pharmacy	Westmead	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	Institut Jules Bordet	Brussels
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège - Domaine universitaire du Sart Tilman	Liege
Bulgaria	"MHAT- Dr. Hristo Stambolski" EOOD	Kazanlak
Bulgaria	MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department	Kozloduy
Bulgaria	MHAT "Sv. Nikolay Chudotvorets" EOOD	Lom
Bulgaria	UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence	Pleven
Bulgaria	UMHAT "Sveti Georgi" EAD	Plovdiv
Bulgaria	"Center for Mental Health - Ruse" EOOD	Ruse
Bulgaria	SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD	Ruse
Bulgaria	''Medical Center-1-Sevlievo'' EOOD	Sevlievo
Bulgaria	MHAT -Silistra AD	Silistra
Bulgaria	MC ''Tsaritsa Yoanna''EOOD	Sliven
Bulgaria	"Acibadem City Clinic University Hospital" EOOD	Sofia
Bulgaria	Acibadem City Clinic Tokuda Ead	Sofia
Bulgaria	MC 'Cardiohelp' EOOD	Sofia
Bulgaria	MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases	Sofia
Bulgaria	"SHATPD-Troyan" EOOD	Troyan
Bulgaria	MC Medica Plus OOD	Veliko Tarnovo
Bulgaria	MHAT ''Sveta Petka" AD	Vidin
Canada	Intermed Groupe Santé	Chicoutimi	Quebec
Canada	Q & T Research Outaouais Inc.	Gatineau	Quebec
Canada	Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne	Greenfield Park	Quebec
Canada	The Ottawa Hospital Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario
Canada	ALPHA Recherche Clinique	Quebec
Canada	Centre de recherche du CHU de Quebec-Universite Laval	Quebec
Canada	Centre de recherche Saint-Louis	Quebec
Canada	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec
Canada	Manna Research Inc. (Toronto)	Toronto	Ontario
Canada	Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec	Trois-Rivieres	Quebec
Canada	Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre	Vancouver	British Columbia
Chile	Psicomed Esudios Medicos	Antofagasta	Region DE Antofagasta
Chile	Biomedica Research Group	Santiago	Región Metropolitana
Chile	Fundacion Arriaran	Santiago	Región Metropolitana
Chile	Centro de Investigacion Clínica del Sur	Temuco	IX Region DE LA Araucania
Chile	Hospital Dr. Hernan Henriquez Aravena	Temuco	Region DE LA Araucania
Colombia	Fundación Cardiomet CEQUIN	Armenia	Quindío
Colombia	Clinica de la Costa Ltda.	Barranquilla	Atlantico
Colombia	Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.	Bogota	D.c.
Colombia	Centro Medico Imbanaco de Cali S.A.	Cali	Valle DEL Cauca
Colombia	Fundacion Valle del Lili	Cali	Valle DEL Cauca
Colombia	Fundacion Cardiovascular de Colombia	Floridablanca	Santander
Colombia	Asociación IPS Médicos Internistas de Caldas	Manizales	Caldas
Colombia	Fundacion Centro de Investigacion Clinica - CIC	Medellin	Antioquia
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Colombia	Instituto de Coloproctologia ICO	Medellin	Antioquia
Czechia	Ordinace vseobecneho praktickeho lekare	Benatky nad Jizerou
Czechia	Doktor Brno s.r.o.	Brno	Czech
Czechia	Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni	Kyjov
Czechia	Slezska Nemocnice v Opave, prispevkova organizace	Opava
Czechia	Policska nemocnice s.r.o.,	Policka
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Oblastni nemocnice Pribram, a.s.	Pribram I.
Czechia	Interna a kardiologie s.r.o.	Roznov pod Radhostem
Czechia	Nemocnice Slany, p.o.	Slany
Czechia	Sarkamed s.r.o.	Slany
Czechia	Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem	Usti nad Labem
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Pori Vaccine Research Clinic	Pori
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	Turku Vaccine Research Clinic	Turku
France	CHU DIJON BOURGOGNE- Hopital Francois Mitterrand	Dijon cedex
France	CIC Vaccinologie Cochin- Pasteur 1417	Paris
France	Hopital Nord-CHU Saint Etienne	Saint Priest en Jarez
France	CHRU de Tours- Hopital Bretonneau	Tours Cedex 09
Germany	Emovis GmbH	Berlin
Germany	MECS Cottbus GmbH	Cottbus
Germany	Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann	Dresden
Germany	Universitaetsklinikum Essen, Klinik fuer Infektiologie	Essen
Germany	EUGASTRO GmbH/ Praxis	Leipzig
Germany	Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut	Leipzig
Germany	SIBAmed Studienzentrum GmbH & Co.KG	Leipzig
Germany	Universitaetsmedizin Rostock	Rostock
Germany	Praxis Dr. med. J. Springub/ W. Schwarz	Westerstede
Germany	Studienzentrum Nordwest	Westerstede
Germany	Klinikum Wuerzburg Mitte gGmbH	Wuerzburg
Hungary	Bajai Szent Rokus Korhaz, II Belgyogyaszat	Baja
Hungary	DRC Kft.	Balatonfured
Hungary	Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly	Budapest
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly	Budapest
Hungary	Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly	Budapest
Hungary	Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika	Budapest
Hungary	ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia	Debrecen
Hungary	CRU Hungary Kft.	Encs
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly	Kaposvar
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Nozaki Tokushukai Hospital	Daito	Osaka
Japan	Fukui-Ken Saiseikai Hospital	Fukui
Japan	Fukuyama City Hospital	Fukuyama	Hiroshima
Japan	Iizuka Hospital	Iizuka	Fukuoka
Japan	Seishinkai Inoue Hospital	Itoshima	Fukuoka
Japan	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka
Japan	Tokai Memorial Hospital	Kasugai	Aichi
Japan	Kenwakai Otemachi Hospital	Kitakyushu	Fukuoka
Japan	Medical Corporation Tokushukai Koga General Hospital	Koga	Ibaraki
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Omi Medical Center	Kusatsu	Shiga
Japan	Social Medical Care Corporation Hose-kai Marunouchi Hospital	Matsumoto-City	Nagano Prefecture
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	Daido Clinic	Nagoya	Aichi
Japan	Kamiiida daiichi General Hospital	Nagoya	Aichi
Japan	Nerima General Hospital	Nerima-ku	Tokyo
Japan	Osaki Citizen Hospital	Osaki	Miyagi
Japan	Saga-Ken Medical Centre Koseikan	Saga
Japan	Miyanomori Memorial Hospital	Sapporo-shi	Hokkaido
Japan	Sekino Hospital	Toshima-ku	Tokyo
Japan	Yaizu City Hospital	Yaizu	Shizuoka
Japan	Yokosuka Kyosai Hospital	Yokosuka	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-do
Peru	Hospital Nacional Adolfo Guevara Velasco	Cusco
Peru	Clinica Internacional S.A	Lima
Peru	Hospital Cayetano Heredia	San Martin de Porres	Lima
Peru	Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A	Trujillo, La Libertad
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Synexus Polska Sp. z o.o Oddzial w Gdansku	Gdansk
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach	Katowice
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.	Leczna
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Portugal	Hospital Garcia de Orta	Almada
Portugal	Centro Hospitalar do Baixo Vouga, E.P.E.	Aveiro
Portugal	Hospital de Braga	Braga
Portugal	Hospital Senhora de Oliveira - Guimaraes, E.P.E.	Guimaraes
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.	Vila Nova de Gaia
Slovakia	PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia	Bojnice
Slovakia	Medak s.r.o., Gastroenterologicka ambulancia	Bratislava
Slovakia	Stalerg, s.r.o.	Kosice
Slovakia	KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra	Nitra
Slovakia	Dionea, s.r.o.	Nove Zamky
Slovakia	MEDIPA, s.r.o.	Piestany
Slovakia	MUDr. Viliam Cibik, PhD, s.r.o.	Pruske
Slovakia	Medilex s.r.o., Interna ambulancia	Rimavska Sobota
Slovakia	Plucna ambulancia Hrebenar s.r.o.	Spisska Nova Ves
Slovakia	SPAOLO s.r.o., Ambulancia vnutorneho lekarstva	Stara Tura
Slovakia	MUDr. Zakova, s.r.o.	Trencin
Slovakia	Privatna urologicka ambulancia, s.r.o.	Trencin
Slovakia	Fakutna nemocnica Trnava	Trnava
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Parc de Salut Mar- Hospital del Mar	Barcelona
Spain	EAP Centelles	Centelles	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Sweden	Infektionskliniken, Malarsjukhuset	Eskilstuna
Sweden	Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset	Goteborg
Sweden	Gothia Forum CTC/Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Avdelningen for kliniska provningar, S-huset	Orebro
Sweden	Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus	Stockholm
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City	Taiwan (r.o.c.)
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Heart of England NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	Layton Medical Centre	Blackpool	Lancashire
United Kingdom	NHS Lothian, Western General Hospital	Edinburgh	Midlothian
United Kingdom	Royal Devon & Exeter Hospital	Exeter	Devon
United Kingdom	Fowey River Practice	Fowey	Cornwall
United Kingdom	St James University Hospital	Leeds
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester	Leicestershire
United Kingdom	Oak Tree Surgery	Liskeard	Cornwall
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation trust	Newcastle upon Tyne
United Kingdom	The Alverton Practise, St Clare Medical Centre	Penzance	Cornwall
United Kingdom	Knowle House Surgery	Plymouth	Devon
United Kingdom	Stockport Nhs Foundation Trust	Stockport	Cheshire
United Kingdom	Rame Group Practice, Rame Medical Ltd.	Torpoint	Cornwall
United States	New Mexico VA Healthcare System	Albuquerque	New Mexico
United States	Lehigh Valley Health Network/Network Office of Research and Innovation	Allentown	Pennsylvania
United States	Community Clinical Research Center	Anderson	Indiana
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Clinical Alliance for Research & Education - Infectious Diseases, LLC	Annandale	Virginia
United States	Luminis Health Anne Arundel Medical Center	Annapolis	Maryland
United States	Luminis Health Anne Arundel Medical Center Infusion Center	Annapolis	Maryland
United States	Luminis Health Research Institute: Research Office	Annapolis	Maryland
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Clinical Trial Center University of Colorado Denver, School of Medicine	Aurora	Colorado
United States	University of Colorado Clinical & Translational Research Center Clinic	Aurora	Colorado
United States	University of Colorado Clinical & Translational Research Center Outpatient Clinic	Aurora	Colorado
United States	University of Colorado Denver, School of Medicine	Aurora	Colorado
United States	University of Colorado Department of AIP 2. Pharmacy Bulk Storage	Aurora	Colorado
United States	Tekton Research, Inc.	Austin	Texas
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Meridian Clinical Research LLC	Binghamton	New York
United States	Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research	Bozeman	Montana
United States	Bozeman Health GI Clinic	Bozeman	Montana
United States	Florida Sleep Disorder Center of Brandon	Brandon	Florida
United States	Teradan Clinical Trials	Brandon	Florida
United States	Holston Medical Group	Bristol	Tennessee
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	PMG Research of Bristol, LLC	Bristol	Tennessee
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Aultman Cardiology Clinical Trials	Canton	Ohio
United States	Aultman Hospital	Canton	Ohio
United States	ClinSite, LLC	Canton	Michigan
United States	Infectious Disease of Indiana, PSC	Carmel	Indiana
United States	St. Vincent Outpatient Treatment Center	Carmel	Indiana
United States	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina
United States	Christie Clinic, LLC	Champaign	Illinois
United States	Medical Research South, LLC	Charleston	South Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Southeast Clinical Research	Chiefland	Florida
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	UC Health Physicians Office Clifton	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University Of Cincinnati-Internal Medicine Division of Digestive Diseases	Cincinnati	Ohio
United States	Innovative Research of West FL., Inc.	Clearwater	Florida
United States	Louis Stokes Cleveland VA Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Velocity Clinical Research, Inc.	Cleveland	Ohio
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	Remington-Davis, Incorporated	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Alliance for Multispecialty Reseach, LLC	Coral Gables	Florida
United States	California Kidney Specialist	Covina	California
United States	Usborne Family Medicine	Covina	California
United States	North Texas Infectious Diseases Consultants, P.A.	Dallas	Texas
United States	Synexus US, LP	Dallas	Texas
United States	Kaiser Permanente Daly City	Daly City	California
United States	PriMED Clinical Research	Dayton	Ohio
United States	Omega Research Consultants, LLC	DeBary	Florida
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Accel Research Sites - DeLand Clinical Research Unit	DeLand	Florida
United States	Premier Health Research Center, LLC	Downey	California
United States	J. Lewis Research Inc. / Foothill Family Clinic Draper	Draper	Utah
United States	Duke Early Phase Clinical Research	Durham	North Carolina
United States	Duke University Hospital Investigational Drug Services (IDS) Pharmacy	Durham	North Carolina
United States	Durham VAMC	Durham	North Carolina
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Liberty Family Practice	Erie	Pennsylvania
United States	Westminster Family Medicine	Erie	Pennsylvania
United States	Deaconess Clinic Mt. Pleasant	Evansville	Indiana
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Aa Mrc Llc	Flint	Michigan
United States	Texas Health Care, PLLC	Fort Worth	Texas
United States	University of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	Malcom Randall VA Medical Center Investigational Drug Services	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	PharmQuest	Greensboro	North Carolina
United States	MedPharmics	Gulfport	Mississippi
United States	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	ID Care	Hillsborough	New Jersey
United States	Edward Hines Jr VA Hospital	Hines	Illinois
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Kelsey Research Foundation	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	St. Vincent Hospital & Health Care Center	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions,Inc.	Jacksonville	Florida
United States	PMG Research, Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee
United States	PMG Research,Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee
United States	Paradigm Clinical Research Centers, Inc.	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Central Kentucky Research Associates, LLC	Lexington	Kentucky
United States	Main Street Physician's Care - Waterway	Little River	South Carolina
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Baptist Health Rehabilitation Institute	Little Rock	Arkansas
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	VA Loma Linda Healthcare System Research Pharmacy	Loma Linda	California
United States	Long Beach Clinical Trials	Long Beach	California
United States	Long Beach Clinical Trials Services, Inc.	Long Beach	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Academic Medical Research Institute	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA CTRC Outpatient Unit	Los Angeles	California
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	Marshfield Medical Center - Marshfield	Marshfield	Wisconsin
United States	VA Northern California Health Care System	Mather	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Great Lakes Medical Research LLC	Mentor	Ohio
United States	Advanced Clinical Research	Meridian	Idaho
United States	Solaris Clinical Research	Meridian	Idaho
United States	Synexus US, dba Research Across America	Mesquite	Texas
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Acevedo Clinical Research Associates	Miami	Florida
United States	Doctors Research Institute	Miami	Florida
United States	Finlay Medical Research	Miami	Florida
United States	Next Phase Research Alliance	Miami	Florida
United States	Optimus U. Corp.	Miami	Florida
United States	Charisma Medical and Research Center	Miami Lakes	Florida
United States	Ocean Blue Medical Research Center, Inc.	Miami Springs	Florida
United States	Virginia Research Center LLC	Midlothian	Virginia
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	MOC Research	Mishawaka	Indiana
United States	Coastal Clinical Research, LLC, An AMR Company	Mobile	Alabama
United States	Barnum Medical Research Inc	Natchitoches	Louisiana
United States	Ochsner Center for Primary Care and Wellness	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Barrett Clinic	Omaha	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	HMD Research LLC	Orlando	Florida
United States	Veterans Affairs Palo Alto Health Care System	Palo Alto	California
United States	LinQ Research, LLC	Pearland	Texas
United States	Pines Care Research Center, LLC	Pembroke Pines	Florida
United States	The Pain Center of Arizona	Peoria	Arizona
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Hope Research Institute	Phoenix	Arizona
United States	MedPharmics, LLC	Phoenix	Arizona
United States	Phoenix Clinical LLC	Phoenix	Arizona
United States	Phoenix VA Health Care System	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Progressive Medical Research	Port Orange	Florida
United States	Frandsen Family Medicine DBA Sound Medical Research	Port Orchard	Washington
United States	Columbia Research Group, Inc.	Portland	Oregon
United States	Kaiser Permanente Center For Health Research	Portland	Oregon
United States	VA Portland Healthcare System	Portland	Oregon
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Covigilant Research, LLC	Rancho Mirage	California
United States	Amici Clinical Research	Raritan	New Jersey
United States	Paradigm Clinical Research Centers, Inc.	Redding	California
United States	VA Loma Linda Healthcare System Ambulatory Care System	Redlands	California
United States	Covigilant Research LLC	Riverside	California
United States	Advanced Clinical Research/Gut Whisperer	Riverton	Utah
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Rochester, Methodist Hospital Campus	Rochester	Minnesota
United States	Rochester Clinical Research	Rochester	New York
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	Kaiser Permanente Roseville	Roseville	California
United States	CTSC Clinical Research Center	Sacramento	California
United States	Kaiser Permanente Sacramento	Sacramento	California
United States	Kaiser Permanente South Sacramento	Sacramento	California
United States	Lawrence J. Ellison Ambulatory Care Center	Sacramento	California
United States	One Community Health	Sacramento	California
United States	University of California, Davis Medical Center	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Center for Advanced Medicine	Saint Louis	Missouri
United States	Center For Clinical Studies	Saint Louis	Missouri
United States	Center for Outpatient Health	Saint Louis	Missouri
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Salem VAMC	Salem	Virginia
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	J Lewis Research, Incorporated	Salt Lake City	Utah
United States	J. Lewis Research, Inc./Foothill Family Clinic	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	South Texas Veterans Healthcare System, Audie L Murphy Hospital	San Antonio	Texas
United States	Breakthrough Clinical Trials	San Bernardino	California
United States	VA San Diego Healthcare System	San Diego	California
United States	California Kidney Specialists	San Dimas	California
United States	Kaiser Permanente San Jose	San Jose	California
United States	Kaiser Permanente Santa Clara	Santa Clara	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Alta California Medical Group	Simi Valley	California
United States	Meridian Clinical Research	Sioux City	Iowa
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	J. Lewis Research, Inc. - Jordan River Family Medicine	South Jordan	Utah
United States	Springfield Clinic Infectious Diseases	Springfield	Illinois
United States	Revival Research Institute, LLC	Sterling Heights	Michigan
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Precision Clinical Research, LLC	Sunrise	Florida
United States	Clinical Research Institute of Arizona, LLC	Surprise	Arizona
United States	Waterway Primary Care LLC DBA Tabor City Family Medicine	Tabor City	North Carolina
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Universal Research Group, LLC	Tacoma	Washington
United States	DM Clinical Research	Tomball	Texas
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Trinity Clinical Research	Tullahoma	Tennessee
United States	Preferred Primary Care Physicians, Inc.	Uniontown	Pennsylvania
United States	Kaiser Permanente Walnut Creek	Walnut Creek	California
United States	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington
United States	Soma Medical Center	West Palm Beach	Florida
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  Finland,  France,  Germany,  Hungary,  Japan,  Korea, Republic of,  Peru,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3	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)
Primary	Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 2	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)
Primary	Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1	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
Primary	Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2	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
Primary	Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3	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
Primary	Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 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 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
Primary	Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2	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
Primary	Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3	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
Primary	Number of Participants Reporting Adverse Events (AEs)	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)
Primary	Number of Participants Reporting Serious Adverse Events (SAEs)	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	Number of All Episodes of CDI (Definition 1 and 2) After Dose 3	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)
Secondary	Time to Resolution for Participants With First Primary Episodes of CDI (Definition 1) After Dose 3	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)
Secondary	Proportion of Participants Who Required Medical Attention During First Primary Episode of CDI (Definition 1) After Dose 3	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)
Secondary	Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 3	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)
Secondary	Number of All Episodes of CDI (Definition 1 and 2) After Dose 2	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)
Secondary	Number of Participants With Recurrent Episodes of CDI (Definition 2) After Dose 2	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)
Secondary	Number of First Primary Episode of CDI (Definition 1) After Dose 2 and Before Dose 3	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
Secondary	Number of Participants With Recurrent Episode of CDI (Definition 2) After Dose 2 and Before Dose 3	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

External Links

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