A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects

NCT ID: NCT01459276

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

FAB-6011

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

Group Type: EXPERIMENTAL

Vaccination with FAB-6011

Intervention Type: BIOLOGICAL

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

FLUVALAB

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

Group Type: ACTIVE_COMPARATOR

Vaccination with FluvalAB

Intervention Type: BIOLOGICAL

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Interventions

Vaccination 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.

Intervention Type: BIOLOGICAL

Vaccination 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FAB-6011; FluvalAB

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fluart Innovative Vaccine Ltd, Hungary

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabor Kollar, MD

Role: STUDY_DIRECTOR

Omninvest Ltd

Ferenc Tamás, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Pilisvörösvár

Ágnes Hasitz, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Szentendre

Judit Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Budapest

Barna Bőze, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Hatvan

Tibor Hrutka, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Vecsés

Péter Torzsa, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Budapest

Péter Vajer, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Biatorbágy

Locations

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

Family Doctor's Office

Budapest, , Hungary

Family Doctor's Office

Budapest, , Hungary

Family Doctor's Office

Pilisvörösvár, , Hungary

Countries

Hungary

Other Identifiers

2011-003314-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FluvalAB-H-15

Identifier Type: -

Identifier Source: org_study_id