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

Phase 3

Completed

• Conditions: Varicella
• Interventions: Procedure: Collection of clinical samples

• Registration Number: NCT00127608
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

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 Timeline

• Study Start: 2005-06-07
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-08
• Primary Completion: 2006-07-13
• Study Completion: 2006-07-13
• Results First Submitted: 2017-09-14
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Results First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varicella Group	Collection of clinical samples	Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.

Primary Outcome Measures

Name	Time	Method
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample	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
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)	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.
Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇿 Praha 8, Czechia