Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-08

Study Completion Date

2007-09-10

Brief Summary

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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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Detailed Description

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Conditions

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Varicella

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VarilrixTM

Intervention Type BIOLOGICAL

Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

Interventions

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VarilrixTM

Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

East Melbourne, Victoria, Australia

Site Status

GSK Investigational Site

Melbourne, Victoria, Australia

Site Status

GSK Investigational Site

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED

PMID: 25272081 (View on PubMed)

Study Documents

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