Study summary

The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.

Additional Study Details

Phase
2
Product
ASP0113
Product
Placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
150
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Scientific Results Summary 2
Available Language(s): English
Plain Language Summary
Available Language(s): English
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling out your information to the right and we’ll respond to you.

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    Locations

    Contact Us
    Contact Us
    Withdrawn
    Site DE49004
    Frankfurt am M., Germany, 60596
    Withdrawn
    Site US10022
    Minneapolis, MN, United States, 55455
    Withdrawn
    Site FR33002
    Creteil, France, 94000
    Withdrawn
    Site FR33006
    Lyon, France, 69437
    Completed
    Site FR33004
    Nantes, France, 44000
    Completed
    Site ES34001
    Barcelona, Spain, 8907
    Withdrawn
    Site US10017
    Ft. Worth, TX, United States, 76104
    Withdrawn
    Site US10002
    Charlotte, NC, United States, 28203
    Completed
    Site US10042
    Pittsburgh, PA, United States, 15213
    Completed
    Site US10011
    Seattle, WA, United States, 98195-6175
    Completed
    Site US10018
    New Haven, CT, United States, 06520
    Withdrawn
    Site ES34007
    Palma de Mallorca, Illes Balears, Spain, 07120
    Completed
    Site US10041
    New Orleans, LA, United States, 70121
    Withdrawn
    Site US10052
    Louisville, KY, United States, 40202
    Completed
    Site US10038
    Charlottesville, VA, United States, 22903
    Withdrawn
    Site CA15001
    Montreal, QC, Canada, H3A 1A1
    Completed
    Site US10036
    San Francisco, CA, United States, 94115
    Completed
    Site DE49001
    Berlin, Germany, 13353
    Completed
    Site US10047
    Charleston, SC, United States, 29425
    Withdrawn
    Site DE49011
    Hannover, Germany, 30625
    Completed
    Site DE49003
    Erlangen, Germany, 91054
    Withdrawn
    Site US10005
    Livingston, NJ, United States, 07039
    Withdrawn
    Site US10054
    Spokane, WA, United States, 99204
    Withdrawn
    Site DE49007
    Tubingen, Germany, 72076
    Withdrawn
    Site US10021
    Chapel Hill, NC, United States, 27599-7211
    Completed
    Site US10031
    Richmond, VA, United States, 23298
    Withdrawn
    Site US10051
    Boston, MA, United States, 02115
    Withdrawn
    Site US10025
    San Antonio, TX, United States, 78229
    Completed
    Site DE49008
    Bonn, Germany, 53105
    Completed
    Site ES34003
    Barcelona, Barcelona, Spain, 08003
    Completed
    Site US10020
    Seattle, WA, United States, 98101
    Completed
    Site AU61001
    Adelaide SA, SA, Australia, 5000
    Completed
    Site US10028
    Houston, TX, United States, 77030
    Completed
    Site US10012
    Bronx, NY, United States, 10467
    Completed
    Site DE49002
    Berlin, Germany, 10117
    Completed
    Site ES34004
    Zaragoza, Spain, 50009
    Completed
    Site US10046
    Lexington, KY, United States, 40536
    Completed
    Site US10003
    Los Angeles, CA, United States, 90057
    Completed
    Site US10001
    Cleveland, OH, United States, 44106
    Withdrawn
    Site US10034
    New York, NY, United States, 10029
    Completed
    Site US10057
    Indianapolis, IN, United States, 46202
    Withdrawn
    Site US10024
    Cincinnati, OH, United States, 45219
    Withdrawn
    Site ES34006
    Cordoba, Spain, 14004
    Withdrawn
    Site US10007
    Durham, NC, United States, 27710
    Completed
    Site US10029
    Madison, WI, United States, 53792
    Withdrawn
    Site US10043
    New York, NY, United States, 10016
    Completed
    Site FR33001
    Nice, France, 66001
    Completed
    Site US10050
    Greenville, NC, United States, 27858
    Completed
    Site US10044
    Aurora, CO, United States, 80045
    Withdrawn
    Site US10032
    Columbus, OH, United States, 43210
    Completed
    Site CA15003
    Halifax, NS, Canada, B3H 1V8
    Completed
    Site FR33003
    Montpellier Cedex 5, France, 34295
    Withdrawn
    Site DE49009
    Dresden, Germany, 1307
    Completed
    Site FR33005
    Bordeaux, France, 33000
    Completed
    Site US10049
    Portland, ME, United States, 04102
    Completed
    Site CA15005
    London, ON, Canada, N6A 4V2
    Completed
    Site US10023
    Ann Arbor, MI, United States, 48109-5364
    Completed
    Site US10058
    Atlanta, GA, United States, 30309
    Completed
    Site US10037
    San Francisco, CA, United States, 94143
    Completed
    Site US10048
    Detroit, MI, United States, 48202
    Completed
    Site US10004
    San Diego, CA, United States, 92123
    Completed
    Site US10045
    Buffalo, NY, United States, 14215
    Completed
    Site US10030
    Chicago, IL, United States, 60612
    Completed
    Site US10027
    Nashville, TN, United States, 37232
    Completed
    Site US10013
    Atlanta, GA, United States, 30322
    Completed
    Site CA15006
    Toronto, ON, Canada, M5G2N2
    Completed
    Site AU61004
    Woolloongabba, QLD, Australia, QLD 4102
    Completed
    Site US10026
    Phoenix, AZ, United States, 85054
    Completed
    Site ES34002
    Barcelona, Barcelona, Spain, 08035
    Completed
    Site US10015
    Omaha, NE, United States, 68198
    Withdrawn
    Site DE49006
    Munster, Germany, 48149
    Completed
    Site US10009
    Chicago, IL, United States, 60637
    Completed
    Site US10014
    Salt Lake City, UT, United States, 84132
    Completed
    Site US10016
    St. Louis, MO, United States, 63110
    Completed
    Site CA15004
    Vancouver, BC, Canada, V6Z 1Y6
    Withdrawn
    Site US10056
    Houston, TX, United States, 77030
    Completed
    Site AU61002
    Sydney, NSW, Australia, NSW 2050
    Withdrawn
    Site US10006
    Dallas, TX, United States, 75246
    Withdrawn
    Site US10033
    San Antonio, TX, United States, 78229
    Completed
    Site DE49005
    Hamburg, Germany, 20246
    Withdrawn
    Site US10035
    New Orleans, LA, United States, 70112

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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