Clinical trial NCT01014806: Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Novavax
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 467
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 0-21 days
measure: Immunogenicity by HAI
timeFrame: 21 Days
Secondary outcomes:
measure: Immunogenicity by HAI compared to commercially licensed TIV vaccine
timeFrame: 21 days
measure: Immunogenicity Against drifted strains by HAI
timeFrame: 21 days
measure: Immunogenicity by neuraminidase activity inhibition (NAI)
timeFrame: 21 Days
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: Universtity Clinical Research
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
References: