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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778297
• Other study ID #: FluvalAB-H-05
• Secondary ID: OGYI 28438/82/07
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: May 18, 2012
• Start date: November 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2012
• Source: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Hungary	Pilisvörösvár District Doctor's Office	Pilisvörösvár

Sponsors (1)

Lead Sponsor	Collaborator
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-vaccination HI antibody titre		21-28 days after vaccination	No
Primary	Incidence of adverse reactions		21-28 days after vaccination	Yes
Secondary	Post-vaccination HI antibody titer		110-120 days after vaccination	No