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N/A N=362 Screening

A Study in Adolescent Females to Explore Cytomegalovirus Infection

Infections, Cytomegalovirus

Enrolled (actual)
362
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. — 5; 2 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Blood collection (Procedure); Urine collection (Procedure); Saliva collection (Procedure)
Age
Pediatric · 10+ yrs
Sex
Female
Sponsor
GlaxoSmithKline
Primary completion
Apr 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
3; 0
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
6.9
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
754.1; 8310.0
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
PRIMARY
Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
915.3
SECONDARY
Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
0; 5; 5; 4; 6; 8
SECONDARY
Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
0.4; 2.4; 2.6; 1.8; 3.5; 4.5

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01691820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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