Immunogenicity and Safety of Different Doses of Fluzone® Influenza

Completed · Phase 2

Conditions studied: Influenza

In brief

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

Key facts

Study ID

NCT00253734

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

217

Starts

2005-11-01

Expected to finish

2006-11-01

Last updated by the study team

2013-06-03

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is healthy, as determined by medical history and clinical assessment before entering the study.
• Between the ages of 18 and 49 (greater than or equal to 18 and less than 50)
• Provides written informed consent
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman, menopausal or surgically sterile or negative serum/urine pregnancy test within 24 hours prior to the time of vaccination.

You may not qualify if…

• Breast-feeding or pregnant.
• History of receiving 2003-2004, 2004-2005 or 2005-2006 influenza vaccine.
• Known allergy to eggs or other components of the vaccine (e.g., thimerosal).
• History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
• History of Guillain-Barre Syndrome.
• Immunosuppression as a result of underlying illness or treatment.
• Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
• Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination.
• Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).
• Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus.
• Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period after inoculation with study vaccine.
• Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.
• Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
• Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 28 days (prior to visit 2) following trial vaccination.
• Subject is enrolled in a conflicting clinical trial.
• Thrombocytopenia or bleeding disorder or therapy contraindicating IM vaccination.
• Female planning on becoming pregnant within one month of vaccination.
• Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
• Febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees Fahrenheit) within 72 hours prior to enrollment.
• Receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination.
• Any condition that, in the opinion of the investigator, would pose a health risk to the participant.
• Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site.
• History of drug abuse or alcohol abuse in the five years prior to enrollment.

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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