Pharma-Pen (Formerly Innoject) Auto-injectory TIV

NCT00335855 | Withdrawn Phase 1

• 1 other identifier: 05-0073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Influenza

Keywords

Device, influenza

Interventions

Auto-injector for IM/SC vaccine administration DEVICE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Completion: October 1, 2006
• Last Updated: January 23, 2019

Record last verified: 2009-04

Locations

US (1)