Status:
COMPLETED
Cytomegalovirus Cell-Mediated Immunity
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infections
Eligibility:
FEMALE
12-17 years
Brief Summary
Cytomegalovirus (CMV) is an important cause of illness and occasional deaths in infants who catch the virus before they are born, in newborns, and in children and adults who have weak immune systems. ...
Detailed Description
Cytomegalovirus (CMV) is an important cause of morbidity and occasional mortality in congenitally infected infants and immuno-compromised children and adults, especially human immunodeficiency virus (...
Eligibility Criteria
Inclusion
- Parent/legal guardian and subjects who understand and sign the assent as well as consent forms for this study.
- Subjects who qualify for the Division of Microbiology and Infectious Diseases, NIAID, NIH (DMID) study 04-039, "A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Safety and Efficacy of the Cytomegalovirus gB/MF59 Vaccine in Preventing Systemic Cytomegalovirus Infection in Healthy Adolescent," will be eligible for the initial pre-vaccination blood draw.
- Subjects who meet all inclusion criteria for the DMID 04-039 study and who are vaccinated will be allowed to participate in the remaining portions of this study.
Exclusion
- All subjects who are ineligible for the main DMID 04-039 study will not be eligible for the cell-mediated immunity sub-study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00815165
Start Date
June 1 2006
End Date
August 1 2011
Last Update
September 9 2013
Active Locations (2)
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1
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States, 45229-3026
2
Vanderbilt University - Pediatric - Infectious Diseases
Nashville, Tennessee, United States, 37232-0011