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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.
The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varicella Group | Experimental | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of clinical samples | Procedure | The following samples were obtained from each subject:
After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Prague | 180 81 | Czechia |
Out of 503 samples collected, 6 were not received from the investigator and 12 were insufficient samples. Hence only 485 samples were tested by Q-PCR.
All 13 samples from 1 subject were VZV DNA negative, suggesting the subject did not have varicella. Therefore, this subject was not included in the final analyses and hence not completed.
Similar numbers of subjects presenting with different varicella rash intensities were enrolled:
| ID | Title | Description |
|---|---|---|
| FG000 | Varicella Group | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Varicella Group | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | One subject who was Varicella Zoster Virus (VZV) deoxyribonucleic acid (DNA)-negative in all samples taken, was considered not to have varicella and was not included in the analyses. | Posted | Log Mean | 95% Confidence Interval | VZV genome copies per sample | At Visit 1 (Day 0) | samples | samples |
|
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No solicited, unsolicited or serious adverse events were collected during this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varicella Group | Subjects aged between 0 and 16 years of age, with clinically-diagnosed primary varicella disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
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| samples |
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|
| Primary | 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. | Only VZV DNA-positive samples were considered in this analysis. | Posted | Log Mean | 95% Confidence Interval | VZV genome copies per sample | At Visit 1 (Day 0) | samples | samples |
|
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|
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| Primary | 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. | Only VZV DNA-positive samples were considered in this analysis. | Posted | Log Mean | 95% Confidence Interval | VZV genome copies per sample | At Visit 1 (Day 0) | samples | samples |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| Liquid storage |
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| Vesicle fluid (Dry or Liquid storage) |
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| Vesicle swab (Dry or Liquid storage) |
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Tukey adjustments were made for the comparison. |
| 0.0060 |
| Median Difference (Final Values) |
| -0.4320 |
| 2-Sided |
| 95 |
| -0.7605 |
| -0.1035 |
| Non-Inferiority or Equivalence |
Difference in mean viral load (in log10) (Papule swab minus Vesicle swab) |
| ANOVA | Tukey adjustments were made for the comparison. | 0.9952 | Mean Difference (Final Values) | 0.00132 | 2-Sided | 95 | -0.3171 | 0.3435 | Non-Inferiority or Equivalence | Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab) |
| Geometric mean ratio of viral load (Papule swab over Vesicle fluid) | ANOVA | Geometric mean ratio | 0.36 | 2-Sided | 95 | 0.17 | 0.76 | Non-Inferiority or Equivalence | Geometric mean ratio of viral load (Papule swab over Vesicle fluid) |
| Geometric mean ratio of viral load (Papule swab over Vesicle swab) | ANOVA | Geometric mean Ratio | 0.37 | 2-Sided | 95 | 0.17 | 0.79 | Non-Inferiority or Equivalence | Geometric mean ratio of viral load (Papule swab over Vesicle swab) |
| Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab) | ANOVA | Geometric mean Ratio | 1.00 | 2-Sided | 95 | 0.48 | 2.21 | Non-Inferiority or Equivalence | Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab) |