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Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics

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ClinicalTrials.gov Identifier: NCT00336453
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : December 17, 2009
Sponsor:
Information provided by:
Protein Sciences Corporation

Tracking Information
First Submitted Date  ICMJE June 12, 2006
First Posted Date  ICMJE June 13, 2006
Last Update Posted Date December 17, 2009
Study Start Date  ICMJE October 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
Evaluation of safety and reactogenicity of FluBlok and TIV in healthy children aged 6-59 months [ Time Frame: influenza season ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2006)
To compare safety, reactogenicity and immunogenicity after each dose of two different formulations of FluBlØk to TIV in healthy children aged 6-35 months and one formulation of FluBlØk to TIV in healthy children aged 36-59 months.
Change History Complete list of historical versions of study NCT00336453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
To compare the immunogenicity after each dose of two different formulations of FluBlok to TIV in healthy children aged 6-35 months and one formulation of FluBlok to TIV in healthy children aged 36-59 months. [ Time Frame: Day 0, 28, 56 ]
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 and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics
Official Title  ICMJE Evaluation of the Safety, Reactogenicity and Immunogenicity of FluBlok Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly to Healthy Children Aged 6 To 59 Months
Brief Summary The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.
Detailed Description

Influenza has been identified as a major health problem in young children. Influenza related hospitalizations are very high in children less than 24 months of age and children age 24-59 months have a high rate of medical care utilization due to influenza. Recently, it has been noted that there are deaths attributable to influenza even in previously healthy children. Recent CDC recommendations reflect this growing awareness of the impact of influenza in children and state that virtually all children less than 18 years of age should receive annual influenza vaccination.

Currently available licensed trivalent influenza vaccines (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Influenza Vaccination
    0.5mL dose for intramuscular injection
    Other Names:
    • FluBlok
    • Fluzone
    • rHA
    • rHA0
    • recombinant hemagglutinin
    • TIV
  • Biological: Influenza Vaccination
    0.25mL dose for intramuscular injection
    Other Names:
    • FluBlok
    • Fluzone
    • rHA
    • rHA0
    • recombinant hemagglutinin
    • TIV
Study Arms  ICMJE
  • Experimental: FluBlok-22.5 μg, 6-35 months old
    6-35 months old, FluBlok-22.5 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
    Intervention: Biological: Influenza Vaccination
  • Experimental: FluBlok-45 μg, 6-35 months old
    6-35 months old, FluBlok-45 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
    Intervention: Biological: Influenza Vaccination
  • Active Comparator: TIV-7.5 μg, 6-35 months old
    6-35 months old, 2006-2007 formulation of Fluzone, (sanofi-pasteur, Swiftwater, PA)-7.5 μg of each hemagglutinin antigen: A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Malaysia/2506/2004 like viruses
    Intervention: Biological: Influenza Vaccination
  • Active Comparator: TIV-15 μg, 36-59 months old
    36-59 months old, 2006-2007 formulation of Fluzone (sanofi-pasteur, Swiftwater, PA)-15 μg of each hemagglutinin antigen: A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Malaysia/2506/2004 like viruses
    Intervention: Biological: Influenza Vaccination
  • Experimental: FluBlok-45 μg, 36-59 months old
    36-59 months old, FluBlok-45 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
    Intervention: Biological: Influenza Vaccination
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: December 16, 2009)
156
Original Enrollment  ICMJE
 (submitted: June 12, 2006)
300
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject was:

    1. aged 6-59 months old (inclusive) at enrollment.
    2. in good health (and not on any chronic medications), as determined by medical history and a history directed targeted physical examination.
    3. naïve for previous influenza vaccination prior to study enrollment.
  2. Parents or guardians must:

    1. be able to understand and comply with planned study procedures and be available for all study visits.
    2. provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria:

  1. a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
  2. a history of severe asthma or more than three previous wheezing episodes.
  3. be undergoing immunosuppression as a result of an underlying illness or treatment.
  4. an active neoplastic disease or a history of any hematologic malignancy.
  5. be using oral or parenteral steroids, inhaled steroids or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
  6. a history of receiving influenza vaccine or plans during the study to receive influenza vaccine outside the study.
  7. a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  8. received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  9. have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
  10. a history of severe reactions following immunization.
  11. an acute illness, including an axillary temperature greater than 100.0*F, within 3 days prior to vaccination.
  12. received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 6-month study period.
  13. any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  14. a history of Guillain-Barré syndrome.
  15. be participating concurrently in another clinical trial (either in active phase or in follow-up phase).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
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 NCT00336453
Other Study ID Numbers  ICMJE PSC02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manon Cox, Chief Operating Officer, Protein Sciences Corporation
Study Sponsor  ICMJE Protein Sciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James C King, MD University of Maryland, College Park
PRS Account Protein Sciences Corporation
Verification Date December 2009

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