A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001
LIfT
A Randomized, Observer-Blind, Controlled Phase 1/2a Study of the Safety, Tolerability and Immunogenicity of Fluzone Administered With and Without LIQ001 in Two Cohorts of Healthy Subjects: 18-49 Years of Age and 65 Years of Age or Older.
1 other identifier
interventional
152
1 country
1
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; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 1, 2013
February 1, 2013
1.2 years
October 14, 2010
February 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone.
35 days post-vaccination
Secondary Outcomes (3)
HAI response (Geometric Mean Titer) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
HAI response (Percent with HAI titer greater than or equal to 1:40) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
HAI response (Seroconversion rate) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
Study Arms (3)
Fluzone + 0.45 mg LIQ001
EXPERIMENTALFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (0.45mg)
Fluzone + 1.8 mg LIQ001
EXPERIMENTALFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (1.8mg)
Fluzone
ACTIVE COMPARATORFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)
Interventions
A single vaccination of Fluzone alone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liquidia Technologies, Inc.lead
- Accelovancecollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
Study Sites (1)
Accelovance - Melbourne
Melbourne, Florida, 32935, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Malinoski, MD, PhD
Liquidia Technologies, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 20, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 1, 2013
Record last verified: 2013-02