This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
807
0.1 mL, Intradermal
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Hoover, Alabama, United States
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Days 0 through 7 post vaccination
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
Time frame: Days 0 and 28 post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Time frame: Day 28 post vaccination
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0.1 mL, Intradermal
0.5 mL, Intramuscular
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Milford, Connecticut, United States
Unnamed facility
Pembroke Pines, Florida, United States
...and 18 more locations