Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine
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.
|Influenza||Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine Biological: Vaccination with FluvalAB trivalent influenza vaccine|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content|
- Post-vaccination HI antibody titre [ Time Frame: 21-28 days after vaccination ]
- Incidence of adverse reactions [ Time Frame: 21-28 days after vaccination ]
- Post-vaccination HI antibody titer [ Time Frame: 110-120 days after vaccination ]
|Study Start Date:||November 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
|Experimental: Group 1||
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).
|Active Comparator: Group 2||
Biological: Vaccination with FluvalAB trivalent influenza vaccine
Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778297
|Pilisvörösvár District Doctor's Office|
|Pilisvörösvár, Hungary, 2085|
|Principal Investigator:||Ferenc Tamás, MD||Pilisvörösvár District Doctor's Office|
|Study Director:||Zsuzsa Galambos, MD||Omninvest Ltd.|