Study to Explore CMV Infection in Adolescent Girls
This study is currently recruiting participants.
Verified April 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01691820
First received: September 13, 2012
Last updated: May 2, 2013
Last verified: April 2013
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Purpose
This study aims to estimate the incidence of CMV secondary infections (re-infections/ re-activation) and the incidence of CMV primary infections in adolescent females.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Vaccines |
Procedure: Blood collection Procedure: Urine collection Procedure: Dry urine collection Procedure: Saliva collection Procedure: Urine and/ or saliva collection from newborn in case of pregnancy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | A Study in Adolescent Females to Explore Cytomegalovirus Infection |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of CMV secondary infections determined in all seropositive subjects in terms of antibody concentrations and viral load. [ Time Frame: Every 4 months from Month 0 to Month 36 ] [ Designated as safety issue: No ]
- Occurrence of CMV primary infections determined in all seronegative subjects in terms of antibody concentrations. [ Time Frame: Every 4 months from Month 0 to Month 36 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group S+
CMV seropositive subjects at inclusion
|
Procedure: Blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: Urine collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Procedure: Dry urine collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: Saliva collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Procedure: Urine and/ or saliva collection from newborn in case of pregnancy
Samples collected upon delivery or within 10 days of delivery.
|
|
Experimental: Group S-
CMV seronegative subjects at inclusion
|
Procedure: Blood collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: Urine collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Procedure: Dry urine collection
Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
Procedure: Saliva collection
Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Procedure: Urine and/ or saliva collection from newborn in case of pregnancy
Samples collected upon delivery or within 10 days of delivery.
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691820
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, Alabama | |
| GSK Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Michigan | |
| GSK Investigational Site | Recruiting |
| Stevensville, Michigan, United States, 49127 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Finland | |
| GSK Investigational Site | Recruiting |
| Helsinki, Finland, 00100 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Oulu, Finland, 90220 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01691820 History of Changes |
| Other Study ID Numbers: | 115639 |
| Study First Received: | September 13, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration Finland: Ministry of Social Affairs and Health Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) Brazil: Agência Nacional de Vigilância Sanitária (ANVISA) |
Keywords provided by GlaxoSmithKline:
|
Adolescent females Cytomegalovirus (CMV) |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013