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Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

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ClinicalTrials.gov Identifier: NCT00539981
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Protein Sciences Corporation

Tracking Information
First Submitted Date  ICMJE October 3, 2007
First Posted Date  ICMJE October 5, 2007
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
  • The development of CDC-ILI with a positive NS/TS culture for an influenza virus strain antigenically resembling a strain represented in FluBlok obtained during the acute illness episode [ Time Frame: influenza season ]
  • For each strain represented in FluBlok, equivalence in post-vaccination GMTs among the three lots administered in a subset of subjects at six (6) sites [ Time Frame: first 28 days ]
  • The rate and severity of solicited AEs reported within 7 days of vaccination, all AEs reported within 28 days of vaccination and all SAEs reported for the duration of the study. [ Time Frame: first 28 days ]
Change History Complete list of historical versions of study NCT00539981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Evaluation of the efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ]
  • Demonstration of clinical consistency among three different lots of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: 28 days ]
  • Evaluation of the immunogenicity of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
Official Title  ICMJE Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine In Healthy Adults Aged 18 to 49
Brief Summary The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of subjects.
Detailed Description

All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.

One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok
0.5mL dose for IM injection
Other Names:
  • FluBlok
  • rHA
  • rHA0
  • recombinant hemagglutinin
Study Arms  ICMJE
  • Experimental: FluBlok
    Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2007/08 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/3/2006(H1N1), A/Wisconsin/67/2005(H3N2), and B/Malaysia/2506/2004
    Intervention: Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok
  • Placebo Comparator: Placebo
    0.9% Sodium Chloride
    Intervention: Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2010)
4648
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2007)
4600
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult ages 18-49 years.
  • Provides informed consent prior to any study procedures.
  • Able to comply with all study procedures.
  • Available for follow-up for the duration of the influenza season.
  • Women of child-bearing potential must have had a negative urine pregnancy test at the time of randomization and must be willing to use an adequate form of contraception (includes abstinence, condom with spermicide, licensed hormonal contraceptive, IUD, monogamous relationship with a vasectomized partner) during the course of the study

Exclusion Criteria:

  • 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)
  • Presence of high-risk conditions or other characteristics considered to be indications for influenza vaccination, as defined by the Advisory Committee on Immunization Practices.
  • Acute febrile illness (defined as having a temperature ≥ 100degreesF) or upper respiratory tract illness within 72 hours of vaccination. Subjects with acute febrile illness may be rescheduled after fever resolved.
  • 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.
  • Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
  • Any malignancy diagnosed or treated actively during the past five (5) years, with two (2) exceptions. Subject with ANY history of lymphoproliferative disorder will be excluded. However, subjects with a history of localized non-melanotic skin cancer may be eligible.
  • Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • 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.
  • Receipt of parenteral immunoglobulin or other blood product within the three months prior to study vaccination.
  • 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.
  • Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • History of alcohol or drug abuse in the last 5 years.
  • Not available for three or more consecutive weeks during flu surveillance period.
  • Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00539981
Other Study ID Numbers  ICMJE PSC04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manon Cox, Protein Sciences Corporation
Study Sponsor  ICMJE Protein Sciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John J Treanor, MD University of Rochester
PRS Account Protein Sciences Corporation
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP