Clinical trial NCT01404182: Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons
Official title: Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: seasonal
prevention
influenza
infection
influenza vaccine
vaccine
influenza in humans
Lead sponsor: Fluart Innovative Vaccine Ltd, Hungary
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.

Detailed description: Immunogenicity Objective:

To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Safety and Tolerability Objectives:

To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 60 years, elderly persons aged over 60 years, 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 18-60 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.
* Capability of participants to understand and comply with planned study procedures
* Participants aged above 18 years provide written informed consent prior to initiation of study procedures
* Absence of existence of any exclusion criteria.

Exclusion Criteria:

* Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
* Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine
* History of Guillain-Barré syndrome
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
* Immunosuppressive therapy within the past 36 months
* Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids
* Receipt of immunostimulants,
* Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within the past 3 months
* Suspected or HIV, HBV or HCV infection
* Acute disease and/or axillary temperature ≥37oC within the past 3 days
* Vaccine therapy within the past 4 weeks
* Influenza vaccination (any kind) within the past 6 months
* Experimental drug therapy within the past 4 weeks
* Concomitant participation in another clinical study
* Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study
* Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer
* Alcohol or drug abuse of the participant.

Primary outcomes:
measure: Post vaccination HI antibody titer
timeFrame: 21-28 days following vaccination
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: 21-28 days following vaccination
Other outcomes:
Locations:
city: Pilisvorosvar
country: Hungary
facility: Family Doctor's Office
state: Pest
city: Veszprem
country: Hungary
facility: Fourmed Gyogyhaz Kft.
Study officials:
affiliation: Family Doctor's Office Pilisvorosvar
name: Ferenc Tamás, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fourmed Gyogyhaz Kft.
name: László Sinka, MD
role: PRINCIPAL_INVESTIGATOR
References: