Clinical trial NCT00778297: Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine
Official title: Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: prevention
influenza
infection
vaccine
Influenza vaccine
Influenza in humans
Lead sponsor: Fluart Innovative Vaccine Ltd, Hungary
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-vaccination HI antibody titre
timeFrame: 21-28 days after vaccination
measure: Incidence of adverse reactions
timeFrame: 21-28 days after vaccination
Secondary outcomes:
measure: Post-vaccination HI antibody titer
timeFrame: 110-120 days after vaccination
Other outcomes:
Locations:
city: Pilisvörösvár
country: Hungary
facility: Pilisvörösvár District Doctor's Office
Study officials:
affiliation: Pilisvörösvár District Doctor's Office
name: Ferenc Tamás, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Omninvest Ltd.
name: Zsuzsa Galambos, MD
role: STUDY_DIRECTOR
References: