Pharma-Pen (Formerly Innoject) Auto-injectory TIV

Withdrawn before enrolling · Phase 1

Conditions studied: Influenza

In brief

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 self-administer Influenza vaccines as compared to standard IM injections administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120 healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least four years and who have no experience in giving intramuscular or subcutaneous injections. Subjects will be randomly placed in one of three treatment types. They will receive one injection of commercially available Influenza vaccine and will be evaluated over the course of six months.

Key facts

Study ID

NCT00335855

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Expected to finish

2006-10-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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