Title
Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine
Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content
Phase
N/ALead Sponsor
Omninvest LtdStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
InfluenzaIntervention/Treatment
fluoxetine ...Study Participants
234This 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.
Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).
Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).
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.