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

This study has been completed.
Sponsor:
Information provided by:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00336453
First received: June 12, 2006
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Influenza Vaccination
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Evaluation of safety and reactogenicity of FluBlok and TIV in healthy children aged 6-59 months [ Time Frame: influenza season ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: October 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: Influenza Vaccination
0.25mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV
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
Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV
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
Biological: Influenza Vaccination
0.25mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV
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
Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV
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
Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV

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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336453

Locations
United States, Kentucky
Kentucky pediatric /Adult Research
Bardstown, Kentucky, United States, 40004
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: James C King, MD University of Maryland
  More Information

Additional Information:
Publications:
Responsible Party: Manon Cox, Chief Operating Officer, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00336453     History of Changes
Other Study ID Numbers: PSC02
Study First Received: June 12, 2006
Last Updated: December 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014