Back to resultsImmunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
Primary Purpose
Varicella
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
VarilrixTM
Sponsored by
About this trial
This is an interventional prevention trial for Varicella focused on measuring Varicella, VarilrixTM
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Varilrix Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Subjects With a Varicella Vaccine Response
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.
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Secondary Outcome Measures
Number of Subjects With a Varicella Vaccine Response
Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.
Number of Seropositive Subjects for Anti-varicella Antibodies
The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.
Anti-varicella Antibody Titers
Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
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.
Number of Subjects With Any Fever
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.
Number of Subjects With Any and Related Rash
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).
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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.
Number of Subjects With Serious Adverse Events (SAEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00792623
Brief Title
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 8, 2003 (Actual)
Primary Completion Date
September 10, 2007 (Actual)
Study Completion Date
September 10, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
Varicella, VarilrixTM
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varilrix Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
VarilrixTM
Intervention Description
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
Primary Outcome Measure Information:
Title
Number of Subjects With a Varicella Vaccine Response
Description
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.
Time Frame
At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Title
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Description
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Time Frame
At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With a Varicella Vaccine Response
Description
Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.
Time Frame
At 6.5 months post-transplantation = 2 months post first dose of vaccination
Title
Number of Seropositive Subjects for Anti-varicella Antibodies
Description
The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.
Time Frame
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)
Title
Anti-varicella Antibody Titers
Description
Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Time Frame
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)
Title
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Description
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.
Time Frame
During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any Fever
Description
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.
Time Frame
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any and Related Rash
Description
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).
Time Frame
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
During the active phase of the study (up to Month 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25272081
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208133/178
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
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