The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,098
0.1 mL, Intradermal (ID)
0.1 mL, Intradermal (ID)
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
Unnamed facility
Alabaster, Alabama, United States
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
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Fountain Valley, California, United States
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San Diego, California, United States
Unnamed facility
Stanford, Connecticut, United States
Unnamed facility
Pembroke Pines, Florida, United States
...and 19 more locations
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Time frame: Day 0 and Day 28 post vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Time frame: Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Time frame: Day 0 and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills
Time frame: Days 0 through 7 post-vaccination
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