The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.
GSK Investigational Site
Wuzhou, Guangxi, China
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
Time frame: During the 4-day follow-up period after each dose of study vaccine.
Number of Subjects Reporting Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.
Time frame: During the 4-day follow-up period after each dose of study vaccine.
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. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 31-days follow-up period after each dose of the study vaccine.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing 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 Dose 1 up to one month following last vaccine dose).
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