Last updated: 11/03/2018 00:19:49
Detection and characterisation of varicella zoster virus from dermal lesions of chickenpox-infected patients
GSK study ID
103815
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic acid (DNA) copies per clinical sample
Timeframe: 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)
Timeframe: At Visit 1 (Day 0)
Estimated mean viral load (in log10) by sample types (papule swab, vesicle fluid and vesicle swab)
Timeframe: At Visit 1 (Day 0)
Secondary outcomes:
Not applicable
Interventions:
Procedure/surgery: Collection of clinical samples
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
2006-13-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Varicella
Product
GSK650851A
Collaborators
Not applicable
Study date(s)
June 2005 to July 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
1 days - 16 years
Accepts healthy volunteers
No
- Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Inclusion and exclusion criteria
Inclusion criteria:
- Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-13-07
Actual study completion date
2006-13-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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