This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
224
Intramuscular, three doses
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Truro, Nova Scotia, Canada
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Time frame: One month after (POST) Dose 3.
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Time frame: One month after (POST) Dose 3.
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Time frame: One month after (POST) Dose 3.
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Time frame: One month after (POST) Dose 3.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Time frame: One month after (POST) Dose 3.
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
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Time frame: One month after (POST) Dose 3.
Number of Subjects With 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 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.
Time frame: During the 31 day (Days 0-30) post vaccination
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 up to Last subject last visit on 03/12/2013