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Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
This study is ongoing, but not recruiting participants.
Sponsored by: Protein Sciences Corporation
Information provided by: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00539864
  Purpose

The primary purpose of this study is to compare the safety and reactogenicity of FluBlok to that of TIV. The immunogenicity, and relative efficacy and effectiveness of the two vaccines against naturally occurring influenza also will be evaluated


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine, Recombinant Hemagglutinin
Biological: TIV
Phase III

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of Safety and Reactogenicity of FluBlok®, Trivalent Recombinant Influenza Vaccine, and Comparison of the Immunogenicity, Efficacy and Effectiveness of FluBlok to a Licensed Egg-Grown Influenza Vaccine

Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Frequencies of adverse events (AEs) and serious adverse events (SAEs) solicited in clinic, via Memory Aids and phone calls, and targeted physical evaluations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects in each vaccine group achieving a Day 28 post vaccination serum titer HAI antibody titer of 40 or greater for each vaccine antigen. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Proportion of subjects in each vaccine group achieving a Day 28 post vaccination serum titer HAI antibody titer of 40 or greater for each vaccine antigen. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titers (GMTs) of serum antibodies against vaccine antigens in each vaccine group 28 days after vaccination [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Proportion of subjects in each vaccine group who experience culture-positive CDC ILI and/or culture-positive respiratory illness during the 2007-2008 influenza epidemic season [ Time Frame: influenza season ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2007
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2007/2008 formulation
Biological: Influenza Vaccine, Recombinant Hemagglutinin
0.5mL dose, for IM injection
B: Active Comparator
TIV 2007/2008 formulation
Biological: TIV
0.5mL dose, IM injection

Detailed Description:

The study is a modified double-blind, randomized, controlled, Phase III multi-center clinical trial designed to evaluate the safety and reactogenicity of FluBlOk and the immunogenicity, efficacy and effectiveness of FluBlOk and TIV in healthy adults aged 50 to 64. Subjects will be stratified according to receipt of influenza vaccine during the 2006-07 season (yes/no) and then randomized within the two strata to receive either FluBlOk or TIV as noted in the table below. Subjects and staff will be blinded to the vaccine administered. FluBlOk will be evaluated for safety and reactogenicity and for immunogenicity (measured by HAI antibody titers at Day 0 and 28), efficacy and effectiveness. Subjects will be given a memory aid to record reactogenicity events during the week after immunization. Reactogenicity data from Day 0 to Day 7 will be collected by phone call 8-10 days following vaccination. Reactogenic symptoms persisting beyond day 7 will be recorded as AEs. Subjects will be encouraged to report illnesses that may be compatible with influenza, and will otherwise be contacted bi-weekly by telephone during the influenza season to identify subjects who are experiencing flu like symptoms. NS/TSs will be obtained and cultured for influenza from those who have CDC-ILI or ILI symptoms.

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 50 to 64.
  • Females should be at least 2 years post-menopausal or sterile or practicing accepted form of birth control (including: condom with spermicidal, licensed hormonal contraceptive, abstinence, IUD or monogamous relationship with a vasectomized partner).
  • Healthy, as determined by oral temperature <100.0°F, medical history, and medical assessment w/ brief physical evaluation by RN (if indicated) 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 other than localized prostate cancer, diagnosed or treated actively during the past 5 years. Exceptions: Subjects with a history of lymphoproliferative disorder at any time in their life will be excluded, while subjects with a history of localized nonmelanotic skin cancer that has been completely removed during the past 5 years may be eligible.
  • Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
  • Diagnosis of or treatment for bipolar disorder, severe major depression, schizophrenia or other major psychotic disorder in the past 3 months that is associated with severely impaired judgment or cognition.
  • 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.
  • Use of experimental vaccines or any influenza vaccine other than FluBlOk after May 31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere epidemic seasons.
  • History of severe reactions following immunization with influenza virus vaccines.
  • Moderate to severe acute illness or febrile illness (oral temperature greater than 100degreesF) 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.
  • Subject is not available for three (3) or more consecutive weeks during active influenza season.
  • 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: NCT00539864

Locations
United States, California
Kaiser Permanente Pediatric Clinic - Fresno
Fresno, California, United States, 93726
Kaiser Permanente Pediatric Clinic - Hayward
Hayward, California, United States, 94545
Kaiser Permanente Pediatric Clinic - Roseville
Roseville, California, United States, 95661
Kaiser Permanente Pediatric Clinic - Sacramento
Sacramento, California, United States, 95823
United States, Hawaii
Kaiser Permanente
Honolulu, Hawaii, United States, 96814
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: Roger Baxter, MD Kaiser Permanenter Center for Vaccine Development
  More Information

Responsible Party: Protin Sciences Corporation ( Manon MJ Cox )
Study ID Numbers: PSC06
Study First Received: October 4, 2007
Last Updated: January 10, 2008
ClinicalTrials.gov Identifier: NCT00539864  
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009