A Randomized, Double-blind, Multi-Center Study to Evaluate Safety and Immunogenicity of One Dose of Four FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccines Containing 3.5µgHA, 6µgHA, 9µgHA or 15 µgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects

• Conditions: Immunization of healthy people against influenza virus infection; MedDRA version: 14.0Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2011-003166-32-HU
• Lead Sponsor: Omninvest Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects eligible for enrolment into this study are:
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

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.
• Hypersensivity 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified