Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

NCT00395174 | Completed Phase 3 DMC

• 1 other identifier: PSC03
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older.

  influenza season

Secondary Outcomes (2)

• Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older.

  influenza season

• Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older.

  influenza season

Study Arms (2)

FluBlok

EXPERIMENTAL

Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio 135μg total

Biological: Influenza Vaccination

TIV (Fluzone)

ACTIVE COMPARATOR

Licensed trivalent influenza vaccine (TIV): 2005-2006 formulation containing 15μg of each hemagglutinin derived from A/Wisconsin (H3N2), A/New Caledonia (H1N1) and B/Malaysia 45μg total (Fluzone, sanofi pasteur)

Biological: Influenza Vaccination

Interventions

Influenza Vaccination BIOLOGICAL

0.5mL dose for intramuscular injection

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

FluBlok; TIV (Fluzone)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ambulatory adults aged 65 and older
• Medically stable, as determined by oral temperature \<100.0°F, medical history, and targeted physical examination based on medical history
• Able to understand and comply with planned study procedures
• Provides written informed consent prior to initiation of any study procedure.

You may not qualify if:

• Known allergy to eggs or other vaccine components.
• Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.
• Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed).
• 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
• History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• History of severe reactions following immunization with influenza virus vaccines.
• Moderate to severe acute illness or febrile illness (oral temperature greater than 100\*F) within 1 week prior to vaccination.
• 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.
• Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
• History of alcohol or drug abuse in the last 5 years.
• History of Guillain-Barré Syndrome.
• Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).

Sponsors & Collaborators

• Protein Sciences Corporation: lead

Study Sites (7)

Center of Vaccine Development, Univ. of Maryland

Baltimore, Maryland, 21201, United States

Location

Passport Health Maryland

Baltimore, Maryland, 21230, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Passport Health New Jersey

Shrewsbury, New Jersey, 07702, United States

Location

Rochester Medical Center

Rochester, New York, 14642, United States

Location

Primary Physicians Research

Pittsburgh, Pennsylvania, 15241, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Keitel WA, Treanor JJ, El Sahly HM, Gilbert A, Meyer AL, Patriarca PA, Cox MM. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or =65 years old. Vaccine. 2009 Dec 11;28(2):379-85. doi: 10.1016/j.vaccine.2009.10.037. Epub 2009 Oct 29.

  PMID: 19879222 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

• Wendy A. Keitel, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Hana M. El-Sahly, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• John J. Treanor, MD

  University of Rochester Medical

  PRINCIPAL INVESTIGATOR

• Keith S. Reisinger, MD

  Primary Physicians research

  PRINCIPAL INVESTIGATOR

• Gregory A. Poland, MD

  Mayo Clinic College of Medicine

  PRINCIPAL INVESTIGATOR

• Kenneth D. Lessans, MD

  Passport Health Maryland

  PRINCIPAL INVESTIGATOR

• John J. Minneti, MD

  Passport Health New Jersey

  PRINCIPAL INVESTIGATOR

• Kristen Lyke, MD

  Center of Vaccine Development, University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: November 2, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

US (7)