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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):

Brief Summary:
  • 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].

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza VLP Vaccine Biological: TIV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Low dose Biological: Influenza VLP Vaccine
Single dose; 0.5mL

Experimental: High dose
Investigational Influenza VLP Vaccine 60ug/strain
Biological: Influenza VLP Vaccine
Single dose; 0.5mL

Active Comparator: TIV
Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced
Biological: TIV
Trivalent Influenza Vaccine 15ug/strain, commercially licensed

Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 0-21 days ]
  2. Immunogenicity by HAI [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. Immunogenicity by HAI compared to commercially licensed TIV vaccine [ Time Frame: 21 days ]
  2. Immunogenicity Against drifted strains by HAI [ Time Frame: 21 days ]
  3. Immunogenicity by neuraminidase activity inhibition (NAI) [ Time Frame: 21 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014806

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United States, Florida
Universtity Clinical Research
Pembroke Pines, Florida, United States, 33024
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02908
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Responsible Party: Novavax Identifier: NCT01014806    
Other Study ID Numbers: NVX755.202
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases