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A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01974206

Astellas Study ID

The unique identification code given by the study sponsor.

0113-CL-2001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2013-000464-29

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Condition

Kidney Transplants

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 Years - N/A

Sex

Female & Male

Product

ASP0113

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2013 - Nov 2020

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

150

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site DE49004

Frankfurt am M., Germany, 60596

Site US10022

Minneapolis, United States, 55455

Site FR33002

Creteil, France, 94000

Site FR33006

Lyon, France, 69437

Site FR33004

Nantes, France, 44000

Site ES34001

Barcelona, Spain, 8907

Site US10017

Ft. Worth, United States, 76104

Site US10002

Charlotte, United States, 28203

Site US10042

Pittsburgh, United States, 15213

Site US10011

Seattle, United States, 98195-6175

Site US10018

New Haven, United States, 06520

Site ES34007

Palma de Mallorca, Spain, 07120

Site US10041

New Orleans, United States, 70121

Site US10052

Louisville, United States, 40202

Site US10038

Charlottesville, United States, 22903

Site CA15001

Montreal, Canada, H3A 1A1

Site US10036

San Francisco, United States, 94115

Site DE49001

Berlin, Germany, 13353

Site US10047

Charleston, United States, 29425

Site DE49011

Hannover, Germany, 30625

Site DE49003

Erlangen, Germany, 91054

Site US10005

Livingston, United States, 07039

Site US10054

Spokane, United States, 99204

Site DE49007

Tubingen, Germany, 72076

Site US10021

Chapel Hill, United States, 27599-7211

Site US10031

Richmond, United States, 23298

Site US10051

Boston, United States, 02115

Site US10025

San Antonio, United States, 78229

Site DE49008

Bonn, Germany, 53105

Site ES34003

Barcelona, Spain, 08003

Site US10020

Seattle, United States, 98101

Site AU61001

Adelaide SA, Australia, 5000

Site US10028

Houston, United States, 77030

Site US10012

Bronx, United States, 10467

Site DE49002

Berlin, Germany, 10117

Site ES34004

Zaragoza, Spain, 50009

Site US10046

Lexington, United States, 40536

Site US10003

Los Angeles, United States, 90057

Site US10001

Cleveland, United States, 44106

Site US10034

New York, United States, 10029

Site US10057

Indianapolis, United States, 46202

Site US10024

Cincinnati, United States, 45219

Site ES34006

Cordoba, Spain, 14004

Site US10007

Durham, United States, 27710

Site US10029

Madison, United States, 53792

Site US10043

New York, United States, 10016

Site FR33001

Nice, France, 66001

Site US10050

Greenville, United States, 27858

Site US10044

Aurora, United States, 80045

Site US10032

Columbus, United States, 43210

Site CA15003

Halifax, Canada, B3H 1V8

Site FR33003

Montpellier Cedex 5, France, 34295

Site DE49009

Dresden, Germany, 1307

Site FR33005

Bordeaux, France, 33000

Site US10049

Portland, United States, 04102

Site CA15005

London, Canada, N6A 4V2

Site US10023

Ann Arbor, United States, 48109-5364

Site US10058

Atlanta, United States, 30309

Site US10037

San Francisco, United States, 94143

Site US10048

Detroit, United States, 48202

Site US10004

San Diego, United States, 92123

Site US10045

Buffalo, United States, 14215

Site US10030

Chicago, United States, 60612

Site US10027

Nashville, United States, 37232

Site US10013

Atlanta, United States, 30322

Site CA15006

Toronto, Canada, M5G2N2

Site AU61004

Woolloongabba, Australia, QLD 4102

Site US10026

Phoenix, United States, 85054

Site ES34002

Barcelona, Spain, 08035

Site US10015

Omaha, United States, 68198

Site DE49006

Munster, Germany, 48149

Site US10009

Chicago, United States, 60637

Site US10014

Salt Lake City, United States, 84132

Site US10016

St. Louis, United States, 63110

Site CA15004

Vancouver, Canada, V6Z 1Y6

Site US10056

Houston, United States, 77030

Site AU61002

Sydney, Australia, NSW 2050

Site US10006

Dallas, United States, 75246

Site US10033

San Antonio, United States, 78229

Site DE49005

Hamburg, Germany, 20246

Site US10035

New Orleans, United States, 70112

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