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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014806
• Other study ID #: NVX755.202
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2009
• Last updated: July 16, 2013
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2013
• Source: Novavax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza VLP Vaccine
Single dose; 0.5mL
• TIV
Trivalent Influenza Vaccine 15ug/strain, commercially licensed

Locations

Country	Name	City	State
United States	Research Across America	Dallas	Texas
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Universtity Clinical Research	Pembroke Pines	Florida
United States	Brown University	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)		0-21 days	Yes
Primary	Immunogenicity by HAI		21 Days	No
Secondary	Immunogenicity by HAI compared to commercially licensed TIV vaccine		21 days	No
Secondary	Immunogenicity Against drifted strains by HAI		21 days	No
Secondary	Immunogenicity by neuraminidase activity inhibition (NAI)		21 Days	No