N/A
Completed N=362
A Study in Adolescent Females to Explore Cytomegalovirus Infection
Infections, Cytomegalovirus
Source: ClinicalTrials.gov NCT01691820 ↗
Enrolled (actual)
362
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. — 5; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 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 | — |
| 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 | — |
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.
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. Informational only — not medical advice.