The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,250
0.1 mL, Intradermal
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
Time frame: Day 0 through Day 7 post-vaccination
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
Serum antibody titers for 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 Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.
Time frame: Day 28 post-vaccination
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular 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
Unnamed facility
Hoover, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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San Diego, California, United States
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Milford, Connecticut, United States
...and 35 more locations