Tolerability and Immunogenicity Study of FLUVAL AB Influenza Vaccine (trivalent, seasonal, active ingredient content: 15 µgHA/strain/0.5 mL) in Adults and Elderly Persons

• Conditions: Immunization of healthy people against influenza virus infection; MedDRA version: 14.1Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-002379-32-HU
• Lead Sponsor: Omninvest Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-31
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

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

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.

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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 36 months prior to vaccination;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants,
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
- Suspected or HIV, HBV or HCV infection;
- Acute disease and/or axillary temperature =37oC within 3 days prior to vaccination;
- Vaccine therapy within 4 weeks prior to vaccination;
- Influenza vaccination (any kind) within 6 months prior to vaccination;
- Experimental drug therapy within 4 weeks prior to vaccination;
- 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.

Study & Design

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