Fluval AB Vaccine Serologic Clinical Trial

• Conditions: Immunization of healthy people against influenza virus infections.

• Registration Number: EUCTR2004-001600-12-HU
• Lead Sponsor: OMNINVEST Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-12
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

Healthy adult volunteers above 18 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergy on any ingredient, pregnancy, age under 18 years

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Verification of the fact that in consequence of the vaccination ratio of seroconversion was greater than 30-40 % (in dependence of the age category);Secondary Objective: Verification of the fact that in consequence of the vaccination increase of geometric mean titer was greater than 2 - 2,5 (in dependence of the age category);Primary end point(s): Verification of the fact that in consequence of the vaccination ratio of seroconversion was greater than 30-40 % (in dependence of the age category).<br>Verification of the fact that in consequence of the vaccination increase of geometric mean titer was greater than 2 - 2,5 (in dependence of the age category).