Influenza
Conditions
Keywords
seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans
Brief summary
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.
Interventions
BIOLOGICALVaccination with FAB-6011
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
BIOLOGICALVaccination with FluvalAB
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
Sponsors
Fluart Innovative Vaccine Ltd, Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male and female adult volunteers aged 18 years or older, * mentally competent, * able to understand and comply with all study requirements, * willing and able to give written informed consent prior to initiation of study procedures, * in good health (as determined by clinical judgement of the investigator on the basis of medical history and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known, adequately treated, clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study. * Female subjects aged 18 to 60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study. * Absence of existence of any
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measures of immunogenicity | 21-28 days following vaccination | 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. |
| Measures of safety | 21-28 days following vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measures of long term immunogenicity | 110-120 days following vaccination | 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. |
| Measures of long term safety | 110-120 days following vaccination | 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. |
Countries
Hungary
Outcome results
None listed