This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
Intramuscular, three doses
Intramuscular, three doses
Intramuscular, two doses
GSK Investigational Site
Bratislava, Slovakia
GSK Investigational Site
Bratislava, Slovakia
GSK Investigational Site
Dolný Kubín, Slovakia
GSK Investigational Site
Dunajská Streda, Slovakia
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Time frame: At Month 3
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective 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. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)
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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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GSK Investigational Site
Nové Zámky, Slovakia
GSK Investigational Site
Ružomberok, Slovakia
GSK Investigational Site
Štúrovo, Slovakia
GSK Investigational Site
Trnava, Slovakia
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Month 0 to Month 9)