Clinical trial NCT01691820: A Study in Adolescent Females to Explore Cytomegalovirus Infection
Official title: A Study in Adolescent Females to Explore Cytomegalovirus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Cytomegalovirus
Keywords: Adolescent females
Cytomegalovirus (CMV)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 369
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 4
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 8
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 12
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 16
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 20
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 24
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 28
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 32
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: At Month 36
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 0
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 4
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 8
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 12
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 16
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 20
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 24
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 28
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 32
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
timeFrame: At Month 36
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
timeFrame: At Month 4
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 8
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 12
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 16
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 20
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 24
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 28
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 32
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
timeFrame: At Month 36
Secondary outcomes:
measure: Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
timeFrame: From study Month 0 to Month 36
measure: Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
timeFrame: From study Month 0 to Month 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Jojutla
country: Mexico
facility: GSK Investigational Site
state: Morelos
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: