Status:
WITHDRAWN
Pharma-Pen (Formerly Innoject) Auto-injectory TIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by untrained users to se...
Detailed Description
Pharma-Pen, Inc. (hereinafter "Pharma-Pen") and Virginia Commonwealth University ("VCU") have partnered to demonstrate the safety, effectiveness and tolerability of two versions of the Pharma-Pen(TM) ...
Eligibility Criteria
Inclusion
- All Subjects will be men or women between the ages of 18 and 50 years.
- Able and willing to provide Informed Consent.
- No previous experience of self-administered IM or SC injections.
- In good health (no chronic diseases or medications apart from vitamins and contraceptives) as assessed by the study clinician.
Exclusion
- Have received influenza vaccine or had the flu in the past 4 years.
- Have a known hypersensitivity to eggs, thimerosal or any other vaccines.
- Subjects receiving immunosuppressive therapy within 6 weeks of enrollment.
- Subjects who have a documented immunosuppressive syndrome.
- Persons who have had a serious allergic reaction or other problems after exposure to influenza vaccine.
- Persons with acute respiratory infections or other active infections or illnesses including active neurological disorders.
- Adults with chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus \[HIV\]).
- Adults who have chronic disorders of the pulmonary or cardiovascular systems, including asthma.
- Persons with a history of Guillain-Barré syndrome (GBS).
- Women that are pregnant or expect to become pregnant within the next 6 weeks.
- Persons with history of thrombocytopenia or bleeding disorders.
- Persons who have received a blood or plasma transfusion of immunoglobulin during the past 12 months.
- Current drug abuse or alcoholism as reported by Subject.
- History of alcohol or drug abuse in the last 5 years.
- Have taken any immunosuppressive medications for the duration of the study.
- Current participation in any other clinical trial or planned participation in any clinical trial in the 6 months follow-up period.
- Subjects that state they are unable or unwilling to return to the clinic for the scheduled one month follow-up.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00335855
End Date
October 1 2006
Last Update
January 23 2019
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298