The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
726
Single dose, intramuscular injection
Single dose, intramuscular injection
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Bratislava, Slovakia
GSK Investigational Site
Bratislava, Slovakia
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Days 0 and 21
Number of Subjects Seropositive Against the 3 Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Days 0 and 21
Number of Subjects Seroconverted for the 3 Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Day 21
Seroconversion Factor for the 3 Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Day 21
Number of Subjects Seroprotected for the 3 Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \[oral temperature greater than or equal to 38 degrees Celsius (°C)\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.
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GSK Investigational Site
Bratislava, Slovakia
GSK Investigational Site
Veľký Biel, Slovakia
Time frame: During the 7-day post-vaccination period
Duration of Solicited Local and General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.
Time frame: During the 7-day post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related 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 21-day post-vaccination period
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.
Time frame: During the 21-day post-vaccination period
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: During the entire study period (up to Day 21)