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Sponsored by: |
Protein Sciences Corporation |
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Information provided by: | Protein Sciences Corporation |
ClinicalTrials.gov Identifier: | NCT00395174 |
Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlØk™, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine in Ambulatory Elderly Adults. The study population will consist of approximately 1,350 ambulatory, medically stable adults aged 65 and above who meet the Inclusion/Exclusion Criteria. The primary purpose of this study is to compare the immunogenicity of FluBlØk to that of a U.S. licensed trivalent inactivated vaccine. The safety, reactogenicity and relative efficacy and effectiveness of the two vaccines against naturally occurring influenza also will be evaluated.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: FluBlok (influenza vaccine) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlØk™, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, To a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults |
Estimated Enrollment: | 1350 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | May 2007 |
The study is a double-blind, randomized, controlled, Phase III multi-center clinical trial designed to compare the immunogenicity, safety, and reactogenicity of FluBlØk to TIV in ambulatory, medically stable elderly adults aged 65 years and older. Subjects will be stratified according to receipt of influenza vaccine during the 2005-6 season (yes/no), then randomized to receive either FluBlØk or TIV as noted in the table below. Subjects and staff will be blinded to vaccine product. FluBlØk will be compared to TIV for immunogenicity, safety and reactogenicity (measured by HAI antibody titer at Day 0, 28 and at EOIS. Subjects will be given a memory aid to record reactogenicity events during the week after immunization. Reactogenicity data will be collected by phone call 8-10 days following vaccination. Subjects will be contacted weekly during the influenza season to assess for the occurrence of ILI. Nasal swabs and throat swabs (NS/TS) will be obtained from those who experience fever and/or medically attended acute respiratory illness; these will be cultured for influenza. A final visit for collection of safety information and a serum sample will be made at the EOIS.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Passport Health Maryland | |
Baltimore, Maryland, United States, 21230 | |
Center of Vaccine Development, Univ. of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Minnesota | |
Mayo Clinic College of Medicine | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Passport Health New Jersey | |
Shrewsbury, New Jersey, United States, 07702 | |
United States, New York | |
Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
Primary Physicians Research | |
Pittsburg, Pennsylvania, United States, 15241 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Wendy A. Keitel, MD | Baylor College of Medicine |
Principal Investigator: | Hana M. El-Sahly, MD | Baylor College of Medicine |
Principal Investigator: | John J. Treanor, MD | University of Rochester Medical |
Principal Investigator: | Keith S. Reisinger, MD | Primary Physicians research |
Principal Investigator: | Gregory A. Poland, MD | Mayo Clinic College of Medicine |
Principal Investigator: | Kenneth D. Lessans, MD | Passport Health Maryland |
Principal Investigator: | John J. Minneti, MD | Passport Health New Jersey |
Principal Investigator: | Kristen Lyke, MD | Center of Vaccine Development, University of Maryland |
Study ID Numbers: | PSC03 |
Study First Received: | October 30, 2006 |
Last Updated: | March 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00395174 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Hemagglutinins Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |