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Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlØk™, To a Licensed Vaccine In Elderly Adults
This study is ongoing, but not recruiting participants.
First Received: October 30, 2006   Last Updated: March 26, 2007   History of Changes
Sponsored by: Protein Sciences Corporation
Information provided by: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00395174
  Purpose

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

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
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

Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • To compare the immunogenicity of FluBlØk and TIV in ambulatory elderly adults (65 years or older).

Secondary Outcome Measures:
  • To compare the safety and reactogenicity of TIV and FluBlØk
  • To compare the relative efficacy and effectiveness of the two vaccines for prevention of culture-positive CDC ILI and/or culture-positive medically attended acute respiratory illness during the 2006-2007 influenza epidemic season.

Estimated Enrollment: 1350
Study Start Date: October 2006
Estimated Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ambulatory adults aged 65 and older
  • Medically stable, as determined by oral temperature <100.0°F, medical history, and targeted physical examination based on medical history
  • Able to understand and comply with planned study procedures
  • Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

  • Known allergy to eggs or other vaccine components.
  • Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
  • Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.
  • Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 g/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
  • Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia
  • History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  • Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • History of severe reactions following immunization with influenza virus vaccines.
  • Moderate to severe acute illness or febrile illness (oral temperature greater than 100F) within 1 week prior to vaccination.
  • Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
  • Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • History of alcohol or drug abuse in the last 5 years.
  • History of Guillain-Barré Syndrome.
  • Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395174

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
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
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

No publications provided

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

Keywords provided by Protein Sciences Corporation:
Influenza

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hemagglutinins
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009