Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Study Overview
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Brief Summary
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This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Official Title
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Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Conditions
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Measles, Varicella, Mumps, Rubella

Intervention / Treatment
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* Biological: PriorixTM
* Biological: VarilrixTM
* Biological: Priorix-Tetra®


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 should be enrolled in the study. A male or female between, and including 11 and 24 months of age, at the time of the 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 dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose. Previous vaccination against measles, mumps, rubella and/or varicella. History of measles, mumps, rubella and/or varicella/zoster diseases. Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 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. Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination. 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: 24 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRIORIX-TETRA GROUP<br>Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm. | Biological: Priorix-Tetra®<br>* Subcutaneous injection in left upper arm<br>|
| Active Comparator: PRIORIX + VARILRIX GROUP<br>Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively. | Biological: PriorixTM<br>* Subcutaneous administration in left upper arm<br>Biological: VarilrixTM<br>* Subcutaneous administration in right upper arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values | Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution. | At 42 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Concentrations Against Measles | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). | At 42-days post-vaccination | 
| Antibody Concentrations Against Mumps | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). | At 42-days post-vaccination | 
| Antibody Concentrations Against Rubella | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | At 42-days post-vaccination | 
| Antibody Titers Against Varicela Viruses | Antibody titers were presented as geometric mean titers (GMTs). | At 42-days post-vaccination | 
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry 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 | 
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination. | During the 43-day (Days 0-42) post-vaccination period | 
| 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. 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 | 
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (from Day 0 up to Day 43 or Day 57) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second year of life, one-dose schedule, varicella, rubella, measles, mumps