NCT00127608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2006

Completed
12.6 years until next milestone

Results Posted

Study results publicly available

February 4, 2019

Completed
Last Updated

February 4, 2019

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 4, 2005

Results QC Date

September 14, 2017

Last Update Submit

August 30, 2018

Conditions

Varicella

Outcome Measures

Primary Outcomes (3)

  • Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample

    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)

    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)

    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)

Study Arms (1)

Varicella Group

EXPERIMENTAL

Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease.

Procedure: Collection of clinical samples

Interventions

Collection of clinical samplesPROCEDURE

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.

Varicella Group

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Prague, 180 81, Czechia

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

June 7, 2005

Primary Completion

July 13, 2006

Study Completion

July 13, 2006

Last Updated

February 4, 2019

Results First Posted

February 4, 2019

Record last verified: 2018-08

Locations

CZ(1)