This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.
This was a Phase II prospective, single-blind to dose, randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®, 2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines, were divided into 8 strata based on age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose (0.25mL) Fluzone® or full-dose (0.5mL) Fluzone® by intramuscular injection into the deltoid muscle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,316
A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Pentagon
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Immune Response: Age 18-49
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Time frame: 21 days post-vaccincation
Immune Response: Age 50-64
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64
Time frame: 21 days post-vaccincation
Medical Events: Unsolicited Adverse Events
Assessed through following subjects' recording of oral body temperature, completion of a 21-day symptom diary; subjects' completion of longer-term follow-up surveys to track respiratory symptoms; and a review of the Defense Medical Surveillance System (DMSS) hospitalization and outpatient medical visits database in order to track ICD-9 codes relevant to flu-like illness.
Time frame: 3 - 6 months following vaccination
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