Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014806
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : July 18, 2013
Information provided by (Responsible Party):

November 14, 2009
November 17, 2009
July 18, 2013
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • Adverse Events (AEs) [ Time Frame: 0-21 days ]
  • Immunogenicity by HAI [ Time Frame: 21 Days ]
Same as current
Complete list of historical versions of study NCT01014806 on Archive Site
  • Immunogenicity by HAI compared to commercially licensed TIV vaccine [ Time Frame: 21 days ]
  • Immunogenicity Against drifted strains by HAI [ Time Frame: 21 days ]
  • Immunogenicity by neuraminidase activity inhibition (NAI) [ Time Frame: 21 Days ]
Same as current
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Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
A Phase 2a Randomized, Double-Blind, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults
  • To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.
  • To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008].
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Biological: Influenza VLP Vaccine
    Single dose; 0.5mL
  • Biological: TIV
    Trivalent Influenza Vaccine 15ug/strain, commercially licensed
  • Experimental: Low dose
    Intervention: Biological: Influenza VLP Vaccine
  • Experimental: High dose
    Investigational Influenza VLP Vaccine 60ug/strain
    Intervention: Biological: Influenza VLP Vaccine
  • Active Comparator: TIV
    Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced
    Intervention: Biological: TIV
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy male or female > 60 years of age at the time of the vaccination.
  2. Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
  3. Available by telephone.
  4. Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  2. Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection.
  3. History of hypersensitivity to any component of inactivated influenza vaccines, including egg or egg products, gelatin, or arginine.
  4. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
  5. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
  6. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
  7. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever > 100.5F.
  8. Acute clinically significant pulmonary, including asthma, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
  9. Major congenital defects that may increase the risk for influenza complications.
  10. History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome. Other neurological disorders that are clinically mild and stable with medication, such as mild Parkinson's disease, will not be excluded.
  11. Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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July 2013

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