Study of Two Formulations of GSK Biologicals' Varicella Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life

Conditions
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Varicella

Intervention / Treatment
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* Biological: Varilrix (inactivated varicella vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 21 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VARILRIX HSA-FREE GROUP<br>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). | Biological: Varilrix (inactivated varicella vaccine)<br>* subcutaneously injection<br>|
| Experimental: VARILRIX GROUP<br>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). | Biological: Varilrix (inactivated varicella vaccine)<br>* subcutaneously injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | At 43-57 days after the first vaccine dose (Week 6) | 
| 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]. | At 43-57 days after the first vaccine dose (Week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) | 
| 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. | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) | 
| 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]. | At 86-114 days after the second vaccine dose (Week 12) | 
| 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]. | At 86-114 days after the second vaccine dose (Week 12) | 
| 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. | During the 4-day (Days 0-3) post-vaccination period following each dose | 
| 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. | During the 43-day (Days 0-42) post-vaccination period following each dose | 
| 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. | Within the 43-day (Days 0-42) post-vaccination period following each dose | 
| 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. | From Day 0 up to study end (Day 86-114) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chickenpox, varicella, two-dose schedule, second year of life