Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Collection of clinical samples · 1 trial · 1 indication
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
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.
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.
| Arm | Type | Description |
|---|---|---|
| Varicella Group | EXPERIMENTAL | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
| Name | Type | Description |
|---|---|---|
| Collection of clinical samples | 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. |
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
Collection of clinical samples is used for varicella, also known as chickenpox. It is an investigational product being studied in the context of infectious disease. The associated clinical trial focuses on detecting and characterizing varicella zoster virus from dermal lesions of infected patients.
Collection of clinical samples is developed by GSK plc, which trades under the ticker GSK. The company is conducting research on this product in the area of varicella, a viral infection.
Collection of clinical samples is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial has been completed.
Collection of clinical samples is associated with one completed Phase 3 trial, NCT00127608, titled 'Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients'. The trial enrolled 36 participants in Czechia and was not randomized or blinded.
Collection of clinical samples is not FDA approved. It is an investigational product that has completed a Phase 3 clinical trial for varicella. Approval status has not been established, and it remains in clinical development.