The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,206
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
Péter Vajer
Biatorbágy, Pest County, Hungary
Barna Bőze
Hatvan, Pest County, Hungary
Family Doctor's Office
Szentendre, Pest County, Hungary
Tibor Hrutka
Vecsés, Pest County, Hungary
Measures of immunogenicity
The measures of immunogenicity (by using HI test) are: * the GMTs at Day 0 and at Day 21 * the Day 21/Day 0 geometric mean titer ratios (GMTRs) * the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 21 * the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 21.
Time frame: 21-28 days following vaccination
Measures of safety
The measures of safety are: Number and percentage of subjects with at least * one local reaction between Day 0 and Day 7 * one systemic reaction between Day 0 and Day 7 * one adverse event between Day 0 and visit at Day 21.
Time frame: 21-28 days following vaccination
Measures of long term immunogenicity
The measures of long term immunogenicity (by using HI test) are: * the GMTs at Day 0 and at Day 120 * the Day 120/Day 0 geometric mean titer ratios (GMTRs) * the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 120 * the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 120.
Time frame: 110-120 days following vaccination
Measures of long term safety
The measures of long term safety are: Number and percentage of subjects with at least * one local reaction * one systemic reaction * one adverse event between Day 0 and visit at Day 120.
Time frame: 110-120 days following vaccination
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Family Doctor's Office
Budapest, Hungary
Family Doctor's Office
Budapest, Hungary
Family Doctor's Office
Pilisvörösvár, Hungary