- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00792623
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
October 11, 2018 updated by: GlaxoSmithKline
A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given as a Primary Vaccination at 4.5 Months and 6.5 Months Post-transplantation, in Autologous Stem Cell/ Bone Marrow Transplant Recipients Aged 18 Years and Older.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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East Melbourne, Victoria, Australia, 3002
- GSK Investigational Site
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Melbourne, Victoria, Australia, 3004
- GSK Investigational Site
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Melbourne, Victoria, Australia, 3050
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Screening phase:
- A male or female ≥ 18 years of age at the time of study entry.
- Written informed consent obtained from the subject prior to study entry.
- Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.
Active phase:
- Patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation.
- If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.
Exclusion Criteria:
Screening phase:
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
- History of allergy to any component of the vaccine.
- Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
- Current drug and/or alcohol abuse.
Active phase:
- Use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period.
- Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period.
- Use of rituximab (MabThera) more than 60 days after transplant.
- Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
- History of allergy to any component of the vaccine
- Patients with VZV disease after transplantation and prior to vaccination.
- Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months post-transplantation
- Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
- Current drug and/or alcohol abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Varilrix Group
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.
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Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With a Varicella Vaccine Response
Time Frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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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.
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At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Time Frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
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At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With a Varicella Vaccine Response
Time Frame: At 6.5 months post-transplantation = 2 months post first dose of vaccination
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Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.
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At 6.5 months post-transplantation = 2 months post first dose of vaccination
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Number of Seropositive Subjects for Anti-varicella Antibodies
Time Frame: 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)
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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.
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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)
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Anti-varicella Antibody Titers
Time Frame: 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)
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Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
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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)
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Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Time Frame: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
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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.
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During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
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Number of Subjects With Any Fever
Time Frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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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.
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Number of Subjects With Any and Related Rash
Time Frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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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).
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time Frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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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.
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the active phase of the study (up to Month 24)
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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.
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During the active phase of the study (up to Month 24)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 8, 2003
Primary Completion (ACTUAL)
September 10, 2007
Study Completion (ACTUAL)
September 10, 2007
Study Registration Dates
First Submitted
November 17, 2008
First Submitted That Met QC Criteria
November 17, 2008
First Posted (ESTIMATE)
November 18, 2008
Study Record Updates
Last Update Posted (ACTUAL)
November 8, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208133/178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Statistical Analysis Plan
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 208133/178Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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