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

NCT ID: NCT00127608

Last Updated: 2019-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-07

Study Completion Date

2006-07-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Varicella

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Varicella Group

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

Group Type EXPERIMENTAL

Collection of clinical samples

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Prague, , Czechia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

103815

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Shingles Prevention Study
NCT00007501 COMPLETED PHASE3