Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics
NCT ID: NCT00336453
Last Updated: 2009-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
156 participants
INTERVENTIONAL
2006-10-31
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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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
Influenza Vaccination
0.25mL dose for intramuscular injection
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
Influenza Vaccination
0.5mL dose for intramuscular injection
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
Influenza Vaccination
0.25mL dose for intramuscular injection
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
Influenza Vaccination
0.5mL dose for intramuscular injection
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
Influenza Vaccination
0.5mL dose for intramuscular injection
Interventions
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Influenza Vaccination
0.5mL dose for intramuscular injection
Influenza Vaccination
0.25mL dose for intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
6 Months
59 Months
ALL
Yes
Sponsors
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Protein Sciences Corporation
INDUSTRY
Responsible Party
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Protein Sciences Corporation
Principal Investigators
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James C King, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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Kentucky pediatric /Adult Research
Bardstown, Kentucky, United States
Saint Louis University
St Louis, Missouri, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, United States
Countries
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References
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King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.
Rajendran M, Nachbagauer R, Ermler ME, Bunduc P, Amanat F, Izikson R, Cox M, Palese P, Eichelberger M, Krammer F. Analysis of Anti-Influenza Virus Neuraminidase Antibodies in Children, Adults, and the Elderly by ELISA and Enzyme Inhibition: Evidence for Original Antigenic Sin. mBio. 2017 Mar 21;8(2):e02281-16. doi: 10.1128/mBio.02281-16.
Nachbagauer R, Choi A, Izikson R, Cox MM, Palese P, Krammer F. Age Dependence and Isotype Specificity of Influenza Virus Hemagglutinin Stalk-Reactive Antibodies in Humans. mBio. 2016 Jan 19;7(1):e01996-15. doi: 10.1128/mBio.01996-15.
Related Links
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Related Info
Other Identifiers
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PSC02
Identifier Type: -
Identifier Source: org_study_id