This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
475
Subcutaneous administration in left upper arm
Subcutaneous administration in right upper arm
Subcutaneous injection in left upper arm
GSK Investigational Site
Bucheon-si, South Korea
GSK Investigational Site
Daejeon, South Korea
GSK Investigational Site
Gwangju, South Korea
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.
Time frame: At 42 days post-vaccination
Antibody Concentrations Against Measles
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: 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).
Time frame: 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).
Time frame: At 42-days post-vaccination
Antibody Titers Against Varicela Viruses
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: 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.
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GSK Investigational Site
GyeongSangNam-do, South Korea
GSK Investigational Site
Iksan, South Korea
GSK Investigational Site
Incheon, South Korea
GSK Investigational Site
Jeonju Jeonbuk, South Korea
GSK Investigational Site
Seongnam-si, Gyeonggi-do, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
...and 3 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the entire study period (from Day 0 up to Day 43 or Day 57)