Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

Fluart Innovative Vaccine

Status

Completed

Conditions

Influenza

Treatments

Biological: Vaccination with FluvalAB trivalent influenza vaccine

Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00778297

EudraCT 2007-004239-52

OGYI 28438/82/07

FluvalAB-H-05

Details and patient eligibility

About

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability.

The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult volunteers in good health aged over 18 years, both sexes;
Full contractual capacity of the participants;
Are in good health (as determined by vital signs and medical history);
Negative urine or serum pregnancy test for females of childbearing potential;
Are able to understand and comply with planned study procedures;
Signed informed consent prior to initiation of study procedures;
Absence of existence of any exclusion criteria.

Exclusion criteria

Known allergy to eggs or other components of the vaccine;
History of Guillain-Barré syndrome;
Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
Immunosuppressive therapy in the preceding 36 months;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
Concomitant corticosteroid therapy, including inhaled corticosteroids;
Psychiatric illness and/or concomitant psychiatric drug therapy;
Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
Vaccine therapy within 4 weeks prior to the study;
Influenza vaccination within 6 months prior to the study;
Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
Documented HIV, HBV or HCV infection;
Acute febrile respiratory illness within one week prior to vaccination;
Experimental drug therapy within 1 month prior to vaccination;
Alcohol or drug abuse.