Last updated: 11/07/2018 12:58:28
Immunogenicity and safety of GSK Biologicals' live attenuated varicella vaccine (VARILRIXTM).
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with a varicella vaccine response
Timeframe: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Anti-varicella zoster virus (Anti-VZV) antibody titers
Timeframe: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Secondary outcomes:
Number of subjects with a varicella vaccine response
Timeframe: At 6.5 months post-transplantation = 2 months post first dose of vaccination
Number of seropositive subjects for anti-varicella antibodies
Timeframe: 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
Timeframe: 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
Timeframe: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Number of subjects with any fever
Timeframe: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of subjects with any and related rash
Timeframe: 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)
Timeframe: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of subjects with serious adverse events (SAEs)
Timeframe: During the active phase of the study (up to Month 24)
Interventions:
Enrollment:
45
Primary completion date:
2007-10-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Sasadeusz J et al. (2014) Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis. doi: 10.1111/tid.12295. [Epub ahead of print].
Medical condition
Varicella
Product
SB208133
Collaborators
Not applicable
Study date(s)
September 2003 to September 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Screening phase:
- A male or female ≥ 18 years of age at the time of study entry.
- Screening phase:
- Pregnant or lactating female.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-10-09
Actual study completion date
2007-10-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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