The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives \& outcome measures of the primary phase/study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
110
One IM injection.
GSK Investigational Site
Ghent, Belgium
Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains
Time frame: Days 0 and 21
Seroconversion Rates (SCR)
Time frame: Day 21
Seroprotection Rates (SPR)
Time frame: Days 0 and 21
Seroconversion Factors (SCF)
Time frame: Day 21
Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general signs and symptoms
Time frame: During the 4-day follow-up period after vaccination.
Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general signs and symptoms
Time frame: During the 21-day follow-up period after vaccination.
Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically attended events
Time frame: During the entire study period
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