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Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395174
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : December 17, 2009
Information provided by:
Protein Sciences Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: Influenza Vaccination Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: FluBlok

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
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV

Active Comparator: TIV (Fluzone)

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
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV

Primary Outcome Measures :
  1. Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ]

Secondary Outcome Measures :
  1. Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ]
  2. Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00395174

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United States, Maryland
Center of Vaccine Development, Univ. of Maryland
Baltimore, Maryland, United States, 21201
Passport Health Maryland
Baltimore, Maryland, United States, 21230
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
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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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Manon Cox, Chief Operating Officer, Protein Sciences Corporation Identifier: NCT00395174     History of Changes
Other Study ID Numbers: PSC03
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009
Keywords provided by Protein Sciences Corporation:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs