Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients

August 30, 2018 updated by: GlaxoSmithKline

An Open, Prospective, Non-prophylactic, Non Therapeutic Study for the Detection and Characterisation of Varicella Zoster Virus Collected From Dermal Lesions of Patients Who Are Diagnosed of Having Varicella/Breakthrough Varicella

This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha 8, Czechia, 180 81
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varicella Group
Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.
Procedure: Collection of clinical samples

The following samples were obtained from each subject:

  • Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
  • Papule swabs (PS) from four papules
  • Crusts from two lesions
  • One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.

After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample
Time Frame: At Visit 1 (Day 0)
The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals
At Visit 1 (Day 0)
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)
Time Frame: At Visit 1 (Day 0)
The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
At Visit 1 (Day 0)
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)
Time Frame: At Visit 1 (Day 0)

The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab).

As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.
At Visit 1 (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2005

Primary Completion (Actual)

July 13, 2006

Study Completion (Actual)

July 13, 2006

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 8, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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