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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01691820
Date of registration:	13/09/2012
Prospective Registration:	Yes
Primary sponsor:	GlaxoSmithKline
Public title:	A Study in Adolescent Females to Explore Cytomegalovirus Infection
Scientific title:	A Study in Adolescent Females to Explore Cytomegalovirus Infection
Date of first enrolment:	October 5, 2012
Target sample size:	369
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01691820
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Brazil	Finland	Mexico	United States

Contacts

Name:	GSK Clinical Trials
Address:
Telephone:
Email:
Affiliation:	GlaxoSmithKline

Key inclusion & exclusion 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.

Age minimum: 10 Years
Age maximum: 17 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infections, Cytomegalovirus

Intervention(s)

Procedure: Blood collection

Procedure: Urine collection

Procedure: Saliva collection

Primary Outcome(s)

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 0]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 12]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 20]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 24]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 16]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 16]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 28]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 4]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 24]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 28]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 36]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 8]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 32]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 16]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 36]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 24]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 36]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 8]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 32]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 12]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 32]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 28]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine [Time Frame: At Month 20]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 4]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 8]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). [Time Frame: At Month 12]

Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine [Time Frame: At Month 4]

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: At Month 20]

Secondary Outcome(s)

Number of CMV Seronegative Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. [Time Frame: From study Month 0 to Month 36]

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum [Time Frame: From study Month 0 to Month 36]

Secondary ID(s)

115639

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	25/01/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01691820

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