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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT01014806
First received: November 14, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose
  • 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 Intervention Phase
Influenza
Biological: Influenza VLP Vaccine
Biological: TIV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novavax:

Primary Outcome Measures:
  • Adverse Events (AEs) [ Time Frame: 0-21 days ] [ Designated as safety issue: Yes ]
  • Immunogenicity by HAI [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity by HAI compared to commercially licensed TIV vaccine [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Immunogenicity Against drifted strains by HAI [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Immunogenicity by neuraminidase activity inhibition (NAI) [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Enrollment: 467
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014806

Locations
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
Novavax
  More Information

No publications provided

Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT01014806     History of Changes
Other Study ID Numbers: NVX755.202
Study First Received: November 14, 2009
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014