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

• Conditions: Immunization of healthy people against influenza virus infection.; MedDRA version: 13.1Level: PTClassification code 10059429Term: Influenza immunisationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2011-002158-30-HU
• Lead Sponsor: Omninvest Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-02
• Last Update Posted: 19 March 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 the past 36 months;
Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
Receipt of immunostimulants,
Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within the past 3 months;
Suspected or 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 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of immunogenicity of the vaccine by serology testing from blood samples taken before and 21-28 days after vaccination.;Secondary Objective: Assessment of safety and tolerability of the vaccine on the basis of adverse events.;Primary end point(s): Immunogenicity Objective:<br>Assessment of the fact in consequence of the vaccination ratio of seroconversion was greater than 40% and 30% in age groups respectively.<br>Assessment of the fact in consequence of the vaccination increase in geometric mean titer was greater than 2.5 and 2 in age groups respectively.<br>Assessment of the fact in consequence of the vaccination ratio of HAI tires >=1:40 was greater than 70 and 60% in age groups respectively.<br>;Timepoint(s) of evaluation of this end point: Immunogenicity Objective:<br>Between Days 21 and 28 after vaccination.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety and Tolerability Objectives:<br>Number and percentage of subjects with at least one local reaction between Day 0 and Day 7 after immunization;<br>Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 7 after immunization;<br>Number and percentage of subjects with at least one adverse reaction between Day 0 and Day 21-28.<br>;Timepoint(s) of evaluation of this end point: Safety and Tolerability Objectives:<br>Between Day 0 and Day 21-28.