Pharma-Pen (Formerly Innoject) Auto-Injectory TIV

2014-08-27 03:44:13 | BioPortfolio


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.


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) auto-injector for IM injection (Treatment 1) or SC injection (Treatment 2) by untrained users compared to standard IM injection (Treatment 3) by a licensed healthcare professional (e.g. nurse). Commercially available Influenza vaccine will be used as a model to demonstrate the ease-of-use and effectiveness of the delivery system. The proposed study will compare safety and immunogenicity of three treatments in healthy volunteers: 1) Self-administered flu vaccine given IM by auto-injector in the thigh; 2) Self-administered flu vaccine given subcutaneously by auto-injector in the thigh; 3) Standard IM vaccine administered in the deltoid muscle by a licensed clinician. Primary objectives of this program are to demonstrate that the Pharma-Pen(TM) system can be safely and successfully used by untrained adults to self-inject with vaccines and to show that the resulting immunogenicity is comparable to vaccinations administered by trained medical personnel using conventional syringe/needle technology. There will be secondary information that accrues from the study. The outcomes of the IM route can be compared to the outcomes of the SC route, and the outcomes of the IM route in the deltoid muscle can be compared to the outcomes in the lateral thigh muscle. This safety/proof-of-concept study will be a randomized, single-dose, open-label, parallel, three treatment trial in 120 healthy subjects (male & female, ages 18 to 50 years) who have not received an influenza vaccine for at least four years, meet all inclusion/exclusion criteria, and sign an informed consent form. The individuals should be non-medical individuals with no experience in giving IM or SC injections. Each subject will be randomly assigned to one of three treatments. The study is divided into two successive parts (1A and 1B). Part 1A will be conducted in the first 12 subjects who will be randomized to only Treatment 1 (3 males, 3 females) and Treatment 2 (3 males, 3 females). The purpose of part 1A is to obtain initial safety information on the IM and SC auto-injectors (Pharma-Pen[TM]) in a few carefully observed subjects (10% of total) to assure that the devices are functioning as designed and do not produce significant injury to the injection site. Part 1A will be conducted under the direct supervision of the Medical Investigator (MI). The results of part 1A will be forwarded to the appointed Safety Monitoring Committee (SMC). If serious device deficiencies are detected early in part 1A, the study may be terminated prior to all 12 subjects completing this initial phase. Part 1B will be initiated only after approval of the MI and SMC, based upon the data from the 12 subjects in part 1A. Part 1B will involve the remaining 108 subjects. All injections will be performed under licensed clinician supervision.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention




Auto-injector for IM/SC vaccine administration


Virginia Commonwealth University
United States




National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:44:13-0400

Clinical Trials [2926 Associated Clinical Trials listed on BioPortfolio]

A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack. The study could take appr...

A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Hea...

Needle-free Jet Injection of Reduced-dose, Intradermal, Influenza Vaccine in >= 6 to < 24-month-old Children

This is a sequential phase I and II, controlled, double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children ...

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Primary Objective: To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA) patients. Secondary Objective: To compare the pharmacokinetic (P...

Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects

Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide a...

PubMed Articles [5749 Associated PubMed Articles listed on BioPortfolio]

Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study.

The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA).

DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.

Children are susceptible to severe influenza infections and facilitate community transmission. One potential strategy to improve vaccine immunogenicity in children against seasonal influenza involves ...

Low coverage rate and awareness of influenza vaccine among older people in Shanghai, China: a cross-sectional study.

Older individuals are at high risk for morbidity and mortality due to influenza, and the most effective way to prevent influenza is yearly vaccination. In China, the influenza vaccine is not covered b...

Redefining influenza seasonality at a global scale and aligning it to the influenza vaccine manufacturing cycle: a descriptive time series analysis.

Annual seasonal influenza vaccine manufacturing cycles align with temperate country seasonality in each hemisphere, yet influenza seasonality is poorly defined for many countries. The study introduces...

A 52-Week Study of Dose-Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector.

This open-label, single-arm, dose-blinded, 52-week, registration-phase study evaluated the efficacy and safety of subcutaneous testosterone enanthate auto-injector (SCTE-AI) administered weekly to men...

Medical and Biotech [MESH] Definitions

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

Active immunization where vaccine is administered for therapeutic or preventive purposes. This can include administration of immunopotentiating agents such as BCG vaccine and Corynebacterium parvum as well as biological response modifiers such as interferons, interleukins, and colony-stimulating factors in order to directly stimulate the immune system.

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

More From BioPortfolio on "Pharma-Pen (Formerly Innoject) Auto-Injectory TIV"

Quick Search


Relevant Topics

Influenza or 'flu' is a respiratory illness associated with infection by influenza virus. Symptoms frequently include headache, fever, cough, sore throat, aching muscles and joints. There is a wide spectrum of severity of illness ranging from min...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Searches Linking to this Trial