A Study in Adolescent Females to Explore Cytomegalovirus Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hospital |
Therapuetic Areas: | Immunology / Infectious Diseases, Other |
Healthy: | No |
Age Range: | 10 - 17 |
Updated: | 2/21/2019 |
Start Date: | October 5, 2012 |
End Date: | April 8, 2017 |
The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary
infections (re-infections/re-activations) and the incidence of CMV primary infections in
adolescent females.
infections (re-infections/re-activations) and the incidence of CMV primary infections in
adolescent females.
Inclusion Criteria:
- A female adolescent between, and including 10 and 17 years at the time of enrolment
regardless of pregnancy status and contraception method used or not used.
- Subjects who the investigator believes that the subject and/or the subject's
parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the
requirements of the protocol.
- Written informed assent and/or consent obtained from the subject and/or the
parent(s)/LAR(s) of the subject.
- Subject is likely to remain in the area and/or return for required study Site Visits
and complete Sample Collection Visits.
Exclusion Criteria:
- Child in care.
- Use or planned use of any investigational or non-registered antiviral drug or vaccine
during the study period.
- Known medical history of any recurrent clinical herpes episodes requiring episodic or
chronic suppressive treatment with oral or parenteral antiviral treatment such as
acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during
the year preceding enrolment. Topical anti-viral are allowed.
- Subjects with history of previous vaccination against CMV.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6
months prior to Visit 1 or planned administration during the study. Inhaled and
topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within 3 months prior to
Visit 1 or planned administration during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including
HIV-infection, based on medical history and physical examination (no laboratory
testing required).
- Any major congenital defects, serious chronic illness or organ transplantation.
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