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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00792623
Registration number
NCT00792623
Ethics application status
Date submitted
17/11/2008
Date registered
18/11/2008
Date last updated
8/11/2018
Titles & IDs
Public title
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
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Scientific title
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.
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Secondary ID [1]
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208133/178
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Varicella
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - VarilrixTM
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.
Other interventions: VarilrixTM
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With a Varicella Vaccine Response
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Assessment method [1]
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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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Timepoint [1]
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At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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Primary outcome [2]
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Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
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Assessment method [2]
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Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
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Timepoint [2]
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At 8 months post-transplantation = 1.5 months post-second dose of vaccination
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Secondary outcome [1]
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Number of Subjects With a Varicella Vaccine Response
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Assessment method [1]
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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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Timepoint [1]
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At 6.5 months post-transplantation = 2 months post first dose of vaccination
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Secondary outcome [2]
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Number of Seropositive Subjects for Anti-varicella Antibodies
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Assessment method [2]
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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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Timepoint [2]
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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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Secondary outcome [3]
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Anti-varicella Antibody Titers
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Assessment method [3]
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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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Timepoint [3]
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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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Secondary outcome [4]
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Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
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Assessment method [4]
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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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Timepoint [4]
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During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
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Secondary outcome [5]
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Number of Subjects With Any Fever
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Assessment method [5]
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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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Timepoint [5]
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Secondary outcome [6]
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Number of Subjects With Any and Related Rash
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Assessment method [6]
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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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Timepoint [6]
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Secondary outcome [7]
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
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Assessment method [7]
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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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Timepoint [7]
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During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
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Secondary outcome [8]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [8]
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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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Timepoint [8]
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During the active phase of the study (up to Month 24)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/09/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/09/2007
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - East Melbourne
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Recruitment hospital [2]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00792623
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00792623
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