Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
---|---|
Information provided by: | Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
ClinicalTrials.gov Identifier: | NCT00778297 |
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 | Intervention |
---|---|
Influenza |
Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine Biological: Vaccination with FluvalAB trivalent influenza vaccine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content |
Enrollment: | 234 |
Study Start Date: | November 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental |
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).
|
Group 2: Active Comparator |
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).
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Hungary | |
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. |
Responsible Party: | Omninvest Ltd. ( Ferenc Zimonyi CEO ) |
Study ID Numbers: | FluvalAB-H-05, OGYI 28438/82/07, EudraCT 2007-004239-52 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778297 |
Health Authority: | Hungary: National Institute of Pharmacy |
prevention influenza infection |
vaccine Influenza vaccine Influenza in humans |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |