Study Details

An evaluation of a Cytomegalovirus (CMV) vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

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.
NCT02103426

Astellas Study ID

The unique identification code given by the study sponsor.

0113-CL-0004

EudraCT ID

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

N/A

Condition

Dialysis, Healthy Volunteer, Virus Infections

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - 70 years

Sex

Female & Male

Product

N/A

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

Dec 2013 - May 2016

Masking

Single (Participant)

Enrollment number

48

A Phase 1, Single-Blind, Parallel-Group, Pharmacokinetic and Immunogenicity Study with ASP0113 in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

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 US10003

Orlando, United States, 32809

Site US10001

Baltimore, United States, 21225

Site US10004

Houston, United States, 77099

Site US10009

Los Angeles, United States, 90017