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| Sponsor: | Protein Sciences Corporation |
|---|---|
| Information provided by: | Protein Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT00395174 |
Purpose
The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza Vaccination |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults |
| Enrollment: | 870 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
FluBlok: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio 135μg total |
Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
|
|
TIV (Fluzone): Active Comparator
Licensed trivalent influenza vaccine (TIV): 2005-2006 formulation containing 15μg of each hemagglutinin derived from A/Wisconsin (H3N2), A/New Caledonia (H1N1) and B/Malaysia 45μg total (Fluzone, sanofi pasteur) |
Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
|
Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.
Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Protein Sciences Corporation ( Manon Cox, Chief Operating Officer ) |
| Study ID Numbers: | PSC03 |
| Study First Received: | October 30, 2006 |
| Last Updated: | December 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00395174 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Influenza |
|
Virus Diseases RNA Virus Infections Immunologic Factors Respiratory Tract Diseases Respiratory Tract Infections Hemagglutinins |
Physiological Effects of Drugs Agglutinins Influenza, Human Orthomyxoviridae Infections Pharmacologic Actions |