The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
684
GSK Investigational Site
Busan, South Korea
GSK Investigational Site
Daegu, South Korea
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
Time frame: One month after the second vaccine dose
Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).
Time frame: One month after the second vaccine dose
Number of Subjects Reporting Solicited Symptoms
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Time frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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.
Time frame: During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (2-3 months).
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)
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GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Daejeon, South Korea
GSK Investigational Site
Daejeon, South Korea
GSK Investigational Site
Goyang, South Korea
GSK Investigational Site
Gwangju, South Korea
GSK Investigational Site
Iksan, South Korea
GSK Investigational Site
Incheon, South Korea
GSK Investigational Site
Jeonju Jeonbuk, South Korea
...and 8 more locations
Time frame: From Dose 1 up to 1 month after Dose 2.