Back to resultsStudy of Two Formulations of GSK Biologicals' Varicella Vaccine
Primary Purpose
Varicella
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Varilrix (inactivated varicella vaccine)
Sponsored by
About this trial
This is an interventional prevention trial for Varicella focused on measuring chickenpox, varicella, two-dose schedule, second year of life
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose.
- Previous vaccination against varicella.
- Known history of clinical varicella.
- Known exposure to varicella within 30 days prior to study start.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
- Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.
- Residence in the same household as a high risk person e.g.: new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VARILRIX HSA-FREE GROUP
VARILRIX GROUP
Arm Description
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Outcomes
Primary Outcome Measures
Antibody Titers Against Varicella Zoster Virus (VZV)
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
Secondary Outcome Measures
Number of Seroconverted Subjects for Varicella Antibodies
Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.
Antibody Titers Against Varicella Zoster Virus (VZV)
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.
Number of Subjects With Any Unsolicited Adverse Event (AE)
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568334
Brief Title
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Official Title
Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2007 (Actual)
Primary Completion Date
March 18, 2008 (Actual)
Study Completion Date
April 29, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
chickenpox, varicella, two-dose schedule, second year of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VARILRIX HSA-FREE GROUP
Arm Type
Experimental
Arm Description
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Arm Title
VARILRIX GROUP
Arm Type
Experimental
Arm Description
Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Intervention Type
Biological
Intervention Name(s)
Varilrix (inactivated varicella vaccine)
Intervention Description
subcutaneously injection
Primary Outcome Measure Information:
Title
Antibody Titers Against Varicella Zoster Virus (VZV)
Description
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
Time Frame
At 43-57 days after the first vaccine dose (Week 6)
Title
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Description
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
Time Frame
At 43-57 days after the first vaccine dose (Week 6)
Secondary Outcome Measure Information:
Title
Number of Seroconverted Subjects for Varicella Antibodies
Description
Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.
Time Frame
At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Title
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Description
Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.
Time Frame
At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Title
Antibody Titers Against Varicella Zoster Virus (VZV)
Description
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].
Time Frame
At 86-114 days after the second vaccine dose (Week 12)
Title
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Description
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].
Time Frame
At 86-114 days after the second vaccine dose (Week 12)
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame
During the 4-day (Days 0-3) post-vaccination period following each dose
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.
Time Frame
During the 43-day (Days 0-42) post-vaccination period following each dose
Title
Number of Subjects With Any Unsolicited Adverse Event (AE)
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame
Within the 43-day (Days 0-42) post-vaccination period following each dose
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Day 0 up to study end (Day 86-114)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
21 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose.
Previous vaccination against varicella.
Known history of clinical varicella.
Known exposure to varicella within 30 days prior to study start.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.
Residence in the same household as a high risk person e.g.: new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
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
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Bordány
ZIP/Postal Code
6795
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1040
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
GSK Investigational Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3524
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3528
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3543
Country
Hungary
Facility Name
GSK Investigational Site
City
Szeged
ZIP/Postal Code
6723
Country
Hungary
Facility Name
GSK Investigational Site
City
Zsombó
ZIP/Postal Code
6792
Country
Hungary
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
26762528
Citation
Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016 Jan 13;16:7. doi: 10.1186/s12887-016-0546-5.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109705
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
109705
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
109705
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
109705
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
109705
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109705
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
We'll reach out to this number within 24 hrs