Status:
COMPLETED
Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine
Lead Sponsor:
Fluart Innovative Vaccine Ltd, Hungary
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
NA
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 as...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00778297
Start Date
November 1 2007
End Date
May 1 2008
Last Update
May 21 2012
Active Locations (1)
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1
Pilisvörösvár District Doctor's Office
Pilisvörösvár, Hungary, 2085