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

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine; Biological: Vaccination with FluvalAB trivalent influenza vaccine

• Registration Number: NCT00778297
• Lead Sponsor: Fluart Innovative Vaccine Ltd, Hungary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-01
• Study Completion: 2008-05
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Vaccination with FluvalAB FL-K-004 trivalent flu vaccine	-
Group 2	Vaccination with FluvalAB trivalent influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
Post-vaccination HI antibody titre	21-28 days after vaccination
Incidence of adverse reactions	21-28 days after vaccination

Secondary Outcome Measures

Name	Time	Method
Post-vaccination HI antibody titer	110-120 days after vaccination

Trial Locations

Locations (1)

Pilisvörösvár District Doctor's Office; 🇭🇺 Pilisvörösvár, Hungary