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This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varilrix Group | Experimental | Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VarilrixTM | Biological | Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Varicella Vaccine Response | Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer. | At 8 months post-transplantation = 1.5 months post-second dose of vaccination |
| Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers | Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs). | At 8 months post-transplantation = 1.5 months post-second dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Varicella Vaccine Response | Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer. | At 6.5 months post-transplantation = 2 months post first dose of vaccination |
| Number of Seropositive Subjects for Anti-varicella Antibodies |
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Inclusion Criteria:
Screening phase:
Active phase:
Exclusion Criteria:
Screening phase:
Active phase:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | East Melbourne | Victoria | 3002 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25272081 | Derived | Sasadeusz J, Prince HM, Schwarer A, Szer J, Stork A, Bock HL, Povey M, Nicholson O, Innis BL. Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis. 2014 Dec;16(6):1024-31. doi: 10.1111/tid.12295. Epub 2014 Oct 1. |
| 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 |
|---|---|---|---|
| 208133/178 | Statistical Analysis Plan | 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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Out of the 45 subjects enrolled in the screening phase of the study, 16 subjects did not receive the study vaccine, as they did not meet eligibility criteria, and were hence eliminated from the study active phase.
Subjects in this study were recipients of autologous peripheral stem cell/bone marrow transplants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varilrix Group | Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varilrix Group | Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. |
| 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 | Number of Subjects With a Varicella Vaccine Response | Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-varicella zoster virus (VZV) antibodies for Month 8 time point were available. | Posted | Count of Participants | Participants | At 8 months post-transplantation = 1.5 months post-second dose of vaccination |
|
Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period; Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; Serious adverse events (SAEs): during the entire study, up to Month 24 post-transplantation.
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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 Group | Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltoid region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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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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The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4. |
| At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination) |
| Anti-varicella Antibody Titers | Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs). | At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination) |
| Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. | During the 8-day (Days 0-7) post-vaccination period after each dose and across doses |
| Number of Subjects With Any Fever | Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination. | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
| Number of Subjects With Any and Related Rash | Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related). | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the active phase of the study (up to Month 24) |
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| GSK Investigational Site | Melbourne | Victoria | 3050 | Australia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 208133/178 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208133/178 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208133/178 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208133/178 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208133/178 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers | Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 8 time point were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At 8 months post-transplantation = 1.5 months post-second dose of vaccination |
|
|
|
| Secondary | Number of Subjects With a Varicella Vaccine Response | Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 6.5 time point were available. | Posted | Count of Participants | Participants | At 6.5 months post-transplantation = 2 months post first dose of vaccination |
|
|
|
| Secondary | Number of Seropositive Subjects for Anti-varicella Antibodies | The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis. | Posted | Count of Participants | Participants | At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination) |
|
|
|
| Secondary | Anti-varicella Antibody Titers | Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination) |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. 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 subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses. | Posted | Count of Participants | Participants | During the 8-day (Days 0-7) post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any Fever | Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination. | The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses. | Posted | Count of Participants | Participants | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any and Related Rash | Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related). | The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses. | Posted | Count of Participants | Participants | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. | Posted | Count of Participants | Participants | During the 43-day (Days 0-42) post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. | Posted | Count of Participants | Participants | During the active phase of the study (up to Month 24) |
|
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|
| 1 |
| 29 |
| 5 |
| 29 |
| 14 |
| 29 |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | 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 |
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| Month 12 |
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| Month 24 |
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| Month 12 |
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| Month 24 |
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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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| Any Pain, Across Doses |
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| Grade 3 Pain, Across Doses |
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| Any Redness, Across Doses |
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| Grade 3 Redness, Across Doses |
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| Any Swelling, Across Doses |
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| Grade 3 Swelling, Across Doses |
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| Related Fever, Dose 1 |
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| Any Fever, Dose 2 |
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| Grade 3 Fever, Dose 2 |
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| Related Fever, Dose 2 |
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| Any Fever, Across doses |
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| Grade 3 Fever, Across doses |
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| Related Fever, Across doses |
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| Non-administration site Rash, Dose 1 |
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| Rash with Fever, Dose 1 |
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| Measles/Rubella like Rash, Dose 1 |
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| Varicella like Rash, Dose 1 |
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| Related non-administration site Rash, Dose 1 |
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| Any Rash, Dose 2 |
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| Administration site Rash, Dose 2 |
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| Non-administration site Rash, Dose 2 |
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| Rash with Fever, Dose 2 |
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| Measles/Rubella like Rash, Dose 2 |
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| Varicella like Rash, Dose 2 |
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| Related non-administration site Rash, Dose 2 |
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| Any Rash, Across doses |
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| Administration site Rash, Across Doses |
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| Non-administration site Rash, Across Doses |
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| Rash with Fever, Across Doses |
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| Measles/Rubella like Rash, Across doses |
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| Varicella like Rash, Across doses |
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| Related non-administration site Rash, Across doses |
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