A Study in Adolescent Females to Explore Cytomegalovirus Infection

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01691820
• Collaborator: (none)
• Enrollment: 369
• Locations: 5
• Arms: 3
• Actual Duration (Months): 54.1
• Patients Per Site: 73.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infections, Cytomegalovirus	Procedure: Blood collection; Procedure: Urine collection; Procedure: Saliva collection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 369 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: A Study in Adolescent Females to Explore Cytomegalovirus Infection
• Actual Study Start Date: Oct 5, 2012
• Actual Primary Completion Date: Apr 8, 2017
• Actual Study Completion Date: Apr 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group S+ Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.	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: 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.
Experimental: Group S- Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.	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: 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.
Experimental: Missing serostatus Group Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.	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: 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.

Outcome Measures

Primary Outcome Measures

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

   This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

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

    This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").

Secondary Outcome Measures

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

   This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.

2. Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects [From study Month 0 to Month 36]

   This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35233
2	GSK Investigational Site	Stevensville	Michigan	United States	49127
3	GSK Investigational Site	Helsinki		Finland	00260
4	GSK Investigational Site	Oulu		Finland	90220
5	GSK Investigational Site	Jojutla	Morelos	Mexico	62900

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Feb 19, 2015
• Statistical Analysis Plan - Feb 21, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01691820
• Other Study ID Numbers: 115639
• First Posted: Sep 25, 2012
• Last Update Posted: Apr 27, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by GlaxoSmithKline: Adolescent females; Cytomegalovirus (CMV)
• Additional relevant MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections

Study Results

Participant Flow

Recruitment Details	Enrolment was terminated once approximately 240 seropositive subjects were included in the trial, to obtain approximately 200 evaluable seropositive subjects. The number of seronegative subjects enrolled depended on the seroprevalence of the participating countries.
Pre-assignment Detail	Of the 369 enrolled subjects, 363 were female subjects and 6 were newborns of some subjects. Consent was signed for the newborns to allow testing for CMV disease. The objectives assessed the CMV infections in the adolescent females with a known serostatus (N=362); no demographics, outcome measures, or adverse events were assessed in newborns.

Arm/Group Title	Group S+	Group S-
Arm/Group Description	Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.	Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
Period Title: Overall Study
STARTED	210	152
COMPLETED	184	115
NOT COMPLETED	26	37

Baseline Characteristics

Arm/Group Title	Group S+	Group S-	Total
Arm/Group Description	CMV seropositive subjects, aged 10-17 years at enrollment in the study.	CMV seronegative subjects, aged 10-17 years at enrollment in the study.	Total of all reporting groups
Overall Participants	210	152	362
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	13.5 (2.1)	13.4 (2.2)	13.5 (2.1)
Sex: Female, Male (Count of Participants)
Female	210 100%	152 100%	362 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African Heritage / African American	8 3.8%	8 5.3%	16 4.4%
Asian - South East Asian Heritage	1 0.5%	0 0%	1 0.3%
White - Arabic / North African Heritage	0 0%	1 0.7%	1 0.3%
White - Caucasian / European Heritage	64 30.5%	93 61.2%	157 43.4%
Other	137 65.2%	50 32.9%	187 51.7%

Outcome Measures

1. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	202
anti-Teg IgG - Two-fold and above increases	5 2.4%
anti-Teg IgG -Four-fold and above increases	2 1%

2. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 8

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrolment in the study.
Measure Participants	197
Two-fold and above increases	5 2.4%
Four-fold and above increases	1 0.5%

3. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrolment in the study.
Measure Participants	198
Two-fold and above increases	6 2.9%
Four-fold and above increases	3 1.4%

4. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 16

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	196
Two-fold and above increases	1 0.5%
Four-fold and above increases	0 0%

5. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	191
Two-fold and above increases	5 2.4%
Four-fold and above increases	2 1%

6. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 24

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	189
Two-fold and above increases	6 2.9%
Four-fold and above increases	2 1%

7. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 28

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	188
Two-fold and above increases	5 2.4%
Four-fold and above increases	1 0.5%

8. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	184
Two-fold and above increases	1 0.5%
Four-fold and above increases	1 0.5%

9. Primary Outcome

Title	Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	180
Two-fold and above increases	3 1.4%
Four-fold and above increases	0 0%

10. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results at Month 0 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	206
Geometric Mean (95% Confidence Interval) [EU/mL]	5.4

11. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	5
Geometric Mean (95% Confidence Interval) [EU/mL]	32.2

12. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 8

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	5
Geometric Mean (95% Confidence Interval) [EU/mL]	10.3

13. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	6
Geometric Mean (95% Confidence Interval) [EU/mL]	9.8

14. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 16

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	1
Geometric Mean (95% Confidence Interval) [EU/mL]	26.5

15. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	5
Geometric Mean (95% Confidence Interval) [EU/mL]	10.1

16. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 24

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 24, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	6
Geometric Mean (95% Confidence Interval) [EU/mL]	9.3

17. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)
Time Frame	At Month 28

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 28, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	5
Geometric Mean (95% Confidence Interval) [EU/mL]	8.3

18. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	1
Geometric Mean (95% Confidence Interval) [EU/mL]	14.4

19. Primary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	3
Geometric Mean (95% Confidence Interval) [EU/mL]	6.9

20. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Time Frame	At Month 4

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	8
> 0 Copies/mL	754.1
≥ 6720 Copies/mL	8310.0

21. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Time Frame	At Month 8

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S+
Arm/Group Description	CCMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	11
> 0 Copies/mL	361.5
≥ 6720 Copies/mL	15386.0

22. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.
Measure Participants	10
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	647.4

23. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 16

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.
Measure Participants	9
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	348.7

24. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.
Measure Participants	3
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	199.4

25. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 24

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 24,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	8
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	322.1

26. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
Time Frame	At Month 28

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 28,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	7
> 0 Copies/mL	421.9
≥ 6720 Copies/mL	7369.0

27. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	3
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	186.1

28. Primary Outcome

Title	Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
Description	This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures

Arm/Group Title	Group S+
Arm/Group Description	CMV seropositive subjects aged between 10-17 years at enrollment in the study.
Measure Participants	7
Geometric Mean (95% Confidence Interval) [DNA copies/mL]	915.3

29. Secondary Outcome

Title	Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
Description	This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.
Time Frame	From study Month 0 to Month 36

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S-
Arm/Group Description	CMV seronegative subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	152
Month 0	0 0%
Month 4	5 2.4%
Month 8	5 2.4%
Month 12	4 1.9%
Month 16	6 2.9%
Month 20	8 3.8%
Month 24	12 5.7%
Month 28	8 3.8%
Month 32	9 4.3%
Month 36	12 5.7%

30. Secondary Outcome

Title	Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
Description	This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
Time Frame	From study Month 0 to Month 36

Outcome Measure Data

Analysis Population Description

This analysis was performed on the seronegative subjects with available results at Month 0, or on the seronegative subjects with antibody concentration above 1.136 U/mL for the other time points, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.

Arm/Group Title	Group S-
Arm/Group Description	CMV seronegative subjects, aged between 10-17 years at enrollment in the study.
Measure Participants	152
Month 0	0.4
Month 4	2.4
Month 8	2.6
Month 12	1.8
Month 16	3.5
Month 20	4.5
Month 24	2.7
Month 28	3.5
Month 32	3.4
Month 36	4.5

Adverse Events

Time Frame	Serious adverse events were collected throughout the entire study, from Month 0 up to Month 36.
Adverse Event Reporting Description	There were no Other (Not Including Serious) Adverse Events collected in this study, as there were no vaccines administered.
Arm/Group Title	Group S+		Group S-
Arm/Group Description	CMV seropositive subjects aged 10-17 years at enrollment in the study.		CMV seronegative subjects aged 10-17 years at enrollment in the study.
All Cause Mortality
	Group S+		Group S-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/210 (0%)		0/152 (0%)
Serious Adverse Events
	Group S+		Group S-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/210 (0%)		0/152 (0%)
Other (Not Including Serious) Adverse Events
	Group S+		Group S-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.