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The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VARILRIX HSA-FREE GROUP | Experimental | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
|
| VARILRIX GROUP | Experimental | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varilrix (inactivated varicella vaccine) | Biological | subcutaneously injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titers Against Varicella Zoster Virus (VZV) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4]. | At 43-57 days after the first vaccine dose (Week 6) |
| Antibody Concentrations Against Varicella Zoster Virus (VZV) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL]. | At 43-57 days after the first vaccine dose (Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Varicella Antibodies | Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination. | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Náchod | 547 01 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26762528 | Derived | Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016 Jan 13;16:7. doi: 10.1186/s12887-016-0546-5. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109705 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varilrix HSA-Free Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| FG001 | Varilrix Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varilrix HSA-Free Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| BG001 |
| 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 | Antibody Titers Against Varicella Zoster Virus (VZV) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4]. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 43-57 days after the first vaccine dose (Week 6) |
|
Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
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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 | Varilrix HSA-Free Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (Dose 1) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| 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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| Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination. | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) |
| Antibody Titers Against Varicella Zoster Virus (VZV) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4]. | At 86-114 days after the second vaccine dose (Week 12) |
| Antibody Concentrations Against Varicella Zoster Virus (VZV) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL]. | At 86-114 days after the second vaccine dose (Week 12) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. | During the 4-day (Days 0-3) post-vaccination period following each dose |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination. | During the 43-day (Days 0-42) post-vaccination period following each dose |
| Number of Subjects With Any Unsolicited Adverse Event (AE) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | Within the 43-day (Days 0-42) post-vaccination period following each dose |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | From Day 0 up to study end (Day 86-114) |
| Pardubice |
| 532 03 |
| Czechia |
| GSK Investigational Site | Bordány | 6795 | Hungary |
| GSK Investigational Site | Budapest | 1032 | Hungary |
| GSK Investigational Site | Budapest | 1040 | Hungary |
| GSK Investigational Site | Budapest | 1097 | Hungary |
| GSK Investigational Site | Budapest | 1121 | Hungary |
| GSK Investigational Site | Győr | 9024 | Hungary |
| GSK Investigational Site | Miskolc | 3524 | Hungary |
| GSK Investigational Site | Miskolc | 3528 | Hungary |
| GSK Investigational Site | Miskolc | 3543 | Hungary |
| GSK Investigational Site | Szeged | 6723 | Hungary |
| GSK Investigational Site | Zsombó | 6792 | Hungary |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109705 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109705 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109705 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109705 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109705 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Varilrix Group |
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Varilrix Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
|
|
|
| Primary | Antibody Concentrations Against Varicella Zoster Virus (VZV) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL]. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 43-57 days after the first vaccine dose (Week 6) |
|
|
|
|
| Secondary | Number of Seroconverted Subjects for Varicella Antibodies | Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Count of Participants | Participants | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) |
|
|
|
| Secondary | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Count of Participants | Participants | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) |
|
|
|
| Secondary | Antibody Titers Against Varicella Zoster Virus (VZV) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4]. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 86-114 days after the second vaccine dose (Week 12) |
|
|
|
| Secondary | Antibody Concentrations Against Varicella Zoster Virus (VZV) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL]. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 86-114 days after the second vaccine dose (Week 12) |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in. | Posted | Count of Participants | Participants | During the 43-day (Days 0-42) post-vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Event (AE) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within the 43-day (Days 0-42) post-vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 up to study end (Day 86-114) |
|
|
|
| 0 |
| 122 |
| 2 |
| 122 |
| 103 |
| 122 |
| EG001 | Varilrix Group | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrixâ„¢ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). | 0 | 122 | 5 | 122 | 100 | 122 |
| Breath holding | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Mastoiditis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Redness (Dose 1) | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Swelling (Dose 1) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain (Dose 2) | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Redness (Dose 2) | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Swelling (Dose 2) | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fever (Dose 1) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fever (Dose 2) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Bronchitis (Dose 1) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral infection (Dose 1) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis (Dose 1) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis (Dose 2) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral infection (Dose 2) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis (Dose 2) | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
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 |
| Anti-VZV, Week 12 |
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| Anti-VZV ≥ 25 mIU/mL, Week 12 |
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| Anti-VZV ≥ 50 mIU/mL, Week 6 |
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| Anti-VZV ≥ 50 mIU/mL, Week 12 |
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| Anti-VZV ≥ 75 mIU/mL, Week 6 |
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| Anti-VZV ≥ 75 mIU/mL, Week 12 |
|
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| Grade 3 Pain, Dose 1 |
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| Any Redness, Dose 1 |
|
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| Grade 3 Redness, Dose 1 |
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| Any Swelling, Dose 1 |
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| Grade 3 Swelling, Dose 1 |
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| Any Pain, Dose 2 |
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| Grade 3 Pain, Dose 2 |
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| Any Redness, Dose 2 |
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| Grade 3 Redness, Dose 2 |
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| Any Swelling, Dose 2 |
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| Grade 3 Swelling, Dose 2 |
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| Grade 3 Temperature, Dose 1 |
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| Related Temperature, Dose 1 |
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| Any Rash, Dose 1 |
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| Grade 3 Rash, Dose 1 |
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| Related Rash, Dose 1 |
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| Any Temperature, Dose 2 |
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| Grade 3 Temperature, Dose 2 |
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| Related Temperature, Dose 2 |
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| Any Rash, Dose 2 |
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| Grade 3 Rash, Dose 2 |
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| Related Rash, Dose 2 |
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| Any AE(s), Dose 2 |
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