To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
121
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Norfolk, Virginia, United States
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Time frame: Days 0 to 3 Post-vaccination
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 21 Post-vaccination
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 21 Post-vaccination
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay
Time frame: Day 21 Post-vaccination
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