Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine
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|ClinicalTrials.gov Identifier: NCT00778297|
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : May 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine Biological: Vaccination with FluvalAB trivalent influenza vaccine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||May 2008|
|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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|