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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00792623




Registration number
NCT00792623
Ethics application status
Date submitted
17/11/2008
Date registered
18/11/2008

Titles & IDs
Public title
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
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.
Secondary ID [1] 0 0
208133/178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Varicella 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: VarilrixTM
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With a Varicella Vaccine Response
Timepoint [1] 0 0
At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Primary outcome [2] 0 0
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Timepoint [2] 0 0
At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Secondary outcome [1] 0 0
Number of Subjects With a Varicella Vaccine Response
Timepoint [1] 0 0
At 6.5 months post-transplantation = 2 months post first dose of vaccination
Secondary outcome [2] 0 0
Number of Seropositive Subjects for Anti-varicella Antibodies
Timepoint [2] 0 0
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 outcome [3] 0 0
Anti-varicella Antibody Titers
Timepoint [3] 0 0
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 outcome [4] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Timepoint [4] 0 0
During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Secondary outcome [5] 0 0
Number of Subjects With Any Fever
Timepoint [5] 0 0
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary outcome [6] 0 0
Number of Subjects With Any and Related Rash
Timepoint [6] 0 0
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary outcome [7] 0 0
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Timepoint [7] 0 0
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary outcome [8] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [8] 0 0
During the active phase of the study (up to Month 24)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2007
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00792623