Status:
COMPLETED
A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001
Lead Sponsor:
Liquidia Technologies, Inc.
Collaborating Sponsors:
Accelovance
Children's Hospital Medical Center, Cincinnati
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; heal...
Detailed Description
Significant advances have been made in the design and delivery of vaccines for the prevention of influenza over the decades. However, two major hurdles remain in the global approach to influenza preve...
Eligibility Criteria
Inclusion
- Age 18 to 49 years (Cohort 1) and age 65 or above (Cohort 2)
- For subjects 18 to 49 years of age: in good health as determined by medical history, physical examination, and the clinical judgment of the Principal Investigator (PI)
- For subjects 65 years of age and older: in stable good health as determined by medical history, physical examination, and the clinical judgment of the PI
- Live in the community (including assisted living)
- Available for duration of study (1 year)
- If female, no child-bearing potential or using appropriate measures to prevent pregnancy
- Negative urine pregnancy test for women presumed to be of child-bearing potential within 24 hours of vaccination
- Be eligible for screening
- Provide informed consent
- Have working phone for contact by the study site personnel
Exclusion
- Known allergy to eggs or any other component of Fluzone (including natural latex) or inactivated influenza vaccines or the investigational vaccine
- Received seasonal influenza or H1N1 vaccine in last 6 months
- A diagnosis of influenza within the previous 12 months
- Received any licensed vaccine within the past 1 month
- Receiving nursing home or equivalent care
- For women, breast-feeding or planning to become pregnant during the first three months post-vaccination
- Chronic administration of immunosuppressant(s) or other medication that modifies immune function
- Confirmed immunodeficiency syndrome or disease
- Significant cardiovascular disease including class 3 or 4 congestive heart failure, recent history (last 6 months) of acute myocardial infarction, coronary artery bypass surgery or stent placement, unstable angina, uncontrolled arrhythmia, and for subjects 65 years of age and older, a resting heart rate greater than 100 bpm
- Hypertension that is not well controlled by medication in the judgment of the investigator or is more than 150/95 at enrollment
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Medically significant chronic lung disease, e.g., requiring chronic steroid treatment (oral doses \>10 mg/day)
- Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral, intravenous, or high dose inhaled corticosteroids (mild or intermittent asthma treated with inhaled steroids is acceptable)
- Medically significant acute or progressive hepatic disease
- Medically significant acute or progressive renal disease
- Diabetes mellitus type 2 not under pharmacological control
- A diagnosis of cancer with active treatment within the previous 5 years (except for a localized basal cell carcinoma of the skin)
- History of autoimmune/inflammatory conditions (e.g., rheumatoid arthritis and diabetes mellitus type 1)
- Medically significant acute or progressive neurological disease.
- Seizure disorder that has required treatment within the last 3 years
- History of Guillain-Barre Syndrome (GBS)
- Administration of blood products, immunoglobulin, or investigational vaccine in the 3 months prior to immunization in this study
- Use of investigational product (other than blood, immunoglobulin, or vaccine) in the past 60 days
- Seropositive for HCV, HIV or positive for HBsAg
- History of excessive alcohol use, drug abuse, or significant psychiatric illness
- Unable to complete informed consent
- Abnormal laboratory assessment meeting criteria for a mild, moderate, or severe adverse event
- Any other condition or circumstance which, in the opinion of the PI, poses an unacceptable risk for participation in the study
- Inability to operate and answer a telephone and lack of access to telephone
- Temporary
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01224262
Start Date
September 1 2010
End Date
December 1 2011
Last Update
March 1 2013
Active Locations (1)
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1
Accelovance - Melbourne
Melbourne, Florida, United States, 32935