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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00792623
First received: November 17, 2008
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Varicella Biological: VarilrixTM Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With a Varicella Vaccine Response [ Time Frame: At 8 months post-transplantation = 1.5 months post second dose of vaccination ]
    Vaccine response defined for initially seropositive subjects as having an antibody titer at 8 months post-transplantation >4 fold the pre-vaccination antibody titer.

  • Anti-varicella Antibody Titers [ Time Frame: At 8 months post-transplantation = 1.5 months post second dose of vaccination ]
    Antibody titers were presented as geometric mean titers (GMTs)


Secondary Outcome Measures:
  • Number of Subjects With a Vaccine Response [ Time Frame: A 6.5 months post-transplantation = 2 months post first dose of vaccination ]
    Vaccine response defined for initially seropositive subjects as having an antibody titer at 6.5 months post-transplantation >4 fold the pre-vaccination antibody titer

  • Number of Subjects With Anti-varicella GMTs Avove the Cut-off [ Time Frame: At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination ]
    The cut-off titer was 1:4

  • Anti-varicella Antibody Titers Above the Cut-off [ Time Frame: At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination ]
    Antibody titers were presented as geometric mean titers (GMTs)

  • Number of Subjects With Any Solicited Local Adverse Events [ Time Frame: During the 8-day follow-up period after each vaccination ]
    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 100 millimeters (mm) of injection site.

  • Number of Subjects With Any Fever [ Time Frame: During the 43-day follow-up period after each vaccination ]
    Any = fever equal to or greater than 37.5 °C. Grade 3 fever = fever > 39.0 °C. Related = assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any and Related Rash [ Time Frame: During the 43-day follow-up period after each vaccination ]
    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).

  • Occurrence of Unsolicited Adverse Events (AEs) [ Time Frame: During the 43-day follow-up period after each vaccination ]
    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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Serious Adverse Events [ Time Frame: Over the active phase of the study (up to Month 24) ]
    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.


Enrollment: 45
Actual Study Start Date: September 8, 2003
Study Completion Date: September 10, 2007
Primary Completion Date: September 10, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: VarilrixTM
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792623

Locations
Australia, Victoria
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
GSK Investigational Site
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208133/178
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00792623     History of Changes
Other Study ID Numbers: 208133/178
Study First Received: November 17, 2008
Results First Received: April 19, 2017
Last Updated: April 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Varicella
VarilrixTM

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017