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CompletedNCT01014806Updated Jul 18, 2013

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

A Phase 2 interventional study of Influenza VLP Vaccine and TIV in Influenza, sponsored by Novavax. Completed at 6 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Novavax · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
467
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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].
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Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 467 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

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Lead sponsor

Novavax is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
467 participants (actual)

Study arms

  • Experimental
    Low dose

    Biological: Influenza VLP Vaccine

  • Experimental
    High dose

    Investigational Influenza VLP Vaccine 60ug/strain

    Biological: Influenza VLP Vaccine

  • Active comparator
    TIV

    Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced

    Biological: TIV

Interventions

  • BiologicalInfluenza VLP Vaccine

    Single dose; 0.5mL

  • BiologicalTIV

    Trivalent Influenza Vaccine 15ug/strain, commercially licensed

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: 0-21 days

  2. Immunogenicity by HAI

    Time frame: 21 Days

Secondary outcomes

  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

07

Study locations

6 sites
  • Universtity Clinical Research
    Pembroke Pines, Florida 33024, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Brown University
    Providence, Rhode Island 02908, United States
  • Coastal Carolina Research Center
    Mt. Pleasant, South Carolina 29464, United States
  • Research Across America
    Dallas, Texas 75234, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01014806
Lead sponsor
Novavax
Responsible party
Sponsor
First posted
Nov 17, 2009
Start date
Nov 2009
Primary completion
May 2010
Completion
May 2010
Last update
Jul 18, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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