Influenza
Conditions
Keywords
Fluval AB, influenza, vaccine, immunization, infections
Brief summary
This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Detailed description
For the 2011-2012 vaccination season the following influenza virus strains were recommended to be included in the influenza vaccines: * A/California/7/2009(H1N1)-like virus, * A/Perth/16/2009(H3N2)-like virus, * B/Brisbane/60/2008-like virus. For the 2012-2013 season the following strains were recommended (Amended EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2012/2013, EMA/CHMP/BWP/140597/2012): * A/California/7/2009(H1N1)-like virus, * A/Victoria/361/2011(H3N2)-like virus, * B/Wisconsin/1/2010-like virus. Since the A/H3N2 and the B virus strains were changed, a yearly licence clinical study have to be performed.
Interventions
DRUGFluval AB vaccination
Vaccination with Fluval AB suspension for injection
Sponsors
Fluart Innovative Vaccine Ltd, Hungary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes, mentally competent; * Are in good health (as determined by vital signs 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 volunteers aged 18-59 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. * Capability of participants to understand and comply with planned study procedures; * Participants provide written informed consent prior to initiation of study procedures; * Absence of existence of any
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96 | 21-28 days after immunization | To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection. | From Day 0 until 21-28 days after immunization | Safety and tolerability will be assessed in comparison to available safety and tolerability data on Fluval AB suspension for injection: * number and percentage of subjects with at least one local reaction between Day 0 and Day 21-28. * number and percentage of subjects with at least one systemic reaction between Day 0 and Day 21-28. * number and percentage of subjects with at least one adverse reaction between Day 0 and Day 21-28. |
Countries
Hungary
Outcome results
None listed