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

NCT00336453 | Completed Phase 1 DMC

• 1 other identifier: PSC02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

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.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and reactogenicity of FluBlok and TIV in healthy children aged 6-59 months

  influenza season

Secondary Outcomes (1)

• 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.

  Day 0, 28, 56

Study Arms (5)

FluBlok-22.5 μg, 6-35 months old

EXPERIMENTAL

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

FluBlok-45 μg, 6-35 months old

EXPERIMENTAL

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

TIV-7.5 μg, 6-35 months old

ACTIVE COMPARATOR

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

TIV-15 μg, 36-59 months old

ACTIVE COMPARATOR

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

FluBlok-45 μg, 36-59 months old

EXPERIMENTAL

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

Interventions

Influenza Vaccination BIOLOGICAL

0.5mL dose for intramuscular injection

Also known as: FluBlok, Fluzone, rHA, rHA0, recombinant hemagglutinin, TIV

FluBlok-45 μg, 36-59 months old; FluBlok-45 μg, 6-35 months old; TIV-15 μg, 36-59 months old

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject was:
• aged 6-59 months old (inclusive) at enrollment.
• in good health (and not on any chronic medications), as determined by medical history and a history directed targeted physical examination.
• naïve for previous influenza vaccination prior to study enrollment.
• Parents or guardians must:
• be able to understand and comply with planned study procedures and be available for all study visits.
• provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

You may not qualify if:

• a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
• a history of severe asthma or more than three previous wheezing episodes.
• be undergoing immunosuppression as a result of an underlying illness or treatment.
• an active neoplastic disease or a history of any hematologic malignancy.
• 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.
• a history of receiving influenza vaccine or plans during the study to receive influenza vaccine outside the study.
• a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• 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).
• a history of severe reactions following immunization.
• an acute illness, including an axillary temperature greater than 100.0\*F, within 3 days prior to vaccination.
• 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.
• 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.
• a history of Guillain-Barré syndrome.
• be participating concurrently in another clinical trial (either in active phase or in follow-up phase).

Sponsors & Collaborators

• Protein Sciences Corporation: lead

Study Sites (3)

Kentucky pediatric /Adult Research

Bardstown, Kentucky, 40004, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Primary Physicians Research

Pittsburgh, Pennsylvania, 15241, United States

Location

Related Publications (3)

• 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.

  PMID: 19716456 RESULT

• 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.

  PMID: 28325769 DERIVED

• 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.

  PMID: 26787832 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; FluBlok

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• James C King, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 13, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

US (3)