- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01014806
Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
July 16, 2013 updated by: Novavax
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].
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
467
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Pembroke Pines, Florida, United States, 33024
- Universtity Clinical Research
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Brown University
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South Carolina
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Mt. Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center
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Texas
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Dallas, Texas, United States, 75234
- Research Across America
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female > 60 years of age at the time of the vaccination.
- 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.
- Available by telephone.
- 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:
- 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.
- 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.
- History of hypersensitivity to any component of inactivated influenza vaccines, including egg or egg products, gelatin, or arginine.
- 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.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
- 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.
- Acute clinically significant pulmonary, including asthma, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
- Major congenital defects that may increase the risk for influenza complications.
- 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.
- Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose
|
Single dose; 0.5mL
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Experimental: High dose
Investigational Influenza VLP Vaccine 60ug/strain
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Single dose; 0.5mL
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Active Comparator: TIV
Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced
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Trivalent Influenza Vaccine 15ug/strain, commercially licensed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events (AEs)
Time Frame: 0-21 days
|
0-21 days
|
Immunogenicity by HAI
Time Frame: 21 Days
|
21 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity by HAI compared to commercially licensed TIV vaccine
Time Frame: 21 days
|
21 days
|
Immunogenicity Against drifted strains by HAI
Time Frame: 21 days
|
21 days
|
Immunogenicity by neuraminidase activity inhibition (NAI)
Time Frame: 21 Days
|
21 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
November 14, 2009
First Submitted That Met QC Criteria
November 16, 2009
First Posted (Estimate)
November 17, 2009
Study Record Updates
Last Update Posted (Estimate)
July 18, 2013
Last Update Submitted That Met QC Criteria
July 16, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NVX755.202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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