Clinical trial NCT01459276: A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects
Official title: A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6μgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: 2011-10-25
Enrollment: 1206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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.
* Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
* History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
* History of Guillain-Barré syndrome;
* 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 derivates within the past 3 months;
* Suspected or known 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 subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
* Alcohol or drug abuse of the subject.

Primary outcomes:
measure: Measures of immunogenicity
timeFrame: 21-28 days following vaccination
measure: Measures of safety
timeFrame: 21-28 days following vaccination
Secondary outcomes:
measure: Measures of long term immunogenicity
timeFrame: 110-120 days following vaccination
measure: Measures of long term safety
timeFrame: 110-120 days following vaccination
Other outcomes:
Locations:
city: Biatorbágy
country: Hungary
facility: Péter Vajer
state: Pest
city: Hatvan
country: Hungary
facility: Barna Bőze
state: Pest
city: Szentendre
country: Hungary
facility: Family Doctor's Office
state: Pest
city: Vecsés
country: Hungary
facility: Tibor Hrutka
state: Pest
city: Budapest
country: Hungary
facility: Family Doctor's Office
city: Budapest
country: Hungary
facility: Family Doctor's Office
city: Pilisvörösvár
country: Hungary
facility: Family Doctor's Office
Study officials:
affiliation: Omninvest Ltd
name: Gabor Kollar, MD
role: STUDY_DIRECTOR
affiliation: Family Doctor's Office, Pilisvörösvár
name: Ferenc Tamás, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Szentendre
name: Ágnes Hasitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Budapest
name: Judit Simon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Hatvan
name: Barna Bőze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Vecsés
name: Tibor Hrutka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Budapest
name: Péter Torzsa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Doctor's Office, Biatorbágy
name: Péter Vajer, MD
role: PRINCIPAL_INVESTIGATOR
References: