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

Study Overview
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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.

Official Title
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Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content

Conditions
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Influenza

Intervention / Treatment
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* Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine
* Biological: Vaccination with FluvalAB trivalent influenza vaccine


Participation Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine<br>* Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).<br>|
| Active Comparator: Group 2<br> | Biological: Vaccination with FluvalAB trivalent influenza vaccine<br>* Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-vaccination HI antibody titre |  | 21-28 days after vaccination | 
| Incidence of adverse reactions |  | 21-28 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-vaccination HI antibody titer |  | 110-120 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, influenza, infection, vaccine, Influenza vaccine, Influenza in humans