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

NCT01014806 | Completed Phase 2 DMC

• 1 other identifier: NVX755.202
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 6

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 \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs)

  0-21 days

• Immunogenicity by HAI

  21 Days

Secondary Outcomes (3)

• Immunogenicity by HAI compared to commercially licensed TIV vaccine

  21 days

• Immunogenicity Against drifted strains by HAI

  21 days

• Immunogenicity by neuraminidase activity inhibition (NAI)

  21 Days

Study Arms (3)

Low dose

EXPERIMENTAL

Biological: Influenza VLP Vaccine

High dose

EXPERIMENTAL

Investigational Influenza VLP Vaccine 60ug/strain

Biological: Influenza VLP Vaccine

TIV

ACTIVE COMPARATOR

Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced

Biological: TIV

Interventions

Influenza VLP Vaccine BIOLOGICAL

Single dose; 0.5mL

High dose; Low dose

TIV BIOLOGICAL

Trivalent Influenza Vaccine 15ug/strain, commercially licensed

TIV

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novavax: lead

Study Sites (6)

Universtity Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Brown University

Providence, Rhode Island, 02908, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

US (6)