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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Group Type EXPERIMENTAL

Vaccination with FluvalAB FL-K-004 trivalent flu vaccine

Intervention Type BIOLOGICAL

Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).

Group 2

Group Type ACTIVE_COMPARATOR

Vaccination with FluvalAB trivalent influenza vaccine

Intervention Type BIOLOGICAL

Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).

Interventions

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Vaccination with FluvalAB FL-K-004 trivalent flu vaccine

Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).

Intervention Type BIOLOGICAL

Vaccination with FluvalAB trivalent influenza vaccine

Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes