In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
196
Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid
Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid
Group 3 is experimental with double the usual antigen dosage
PAREXEL Early Phase Clinical Unit
Berlin, Germany
Reactogenicity up to 7 days after vaccination
Safety of aTIV or aTIV-modified formulations
Time frame: Days 1-7 post-vaccination
Unsolicited AEs within 28 days after vaccination
Time frame: Days 1-28 post-vaccination
SAEs, non-scheduled physician visits, unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, NOCDs, and AESIs from study start to study completion.
Time frame: Days 1-366 post-vaccination
Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer 21 days post-vaccination.
Antibody responses to all three influenza virus vaccine strains, 21days after a dose or doses of aTIV or aTIV-modified formulations, as measured by hemagglutination inhibition (HI) assay and microneutralization (MN) assay.
Time frame: Day 22 post-vaccination
HI and MN GMT and GMR at baseline and 21 days post-vaccination.
Time frame: Day 1; Day 22 post-vaccination
Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer, 7 days and 6 months post-vaccination.
Time frame: Day 8 and 181 post-vaccination
HI and MN (GMT) 7 days and 6 months post-vaccination.
To compare HI and MN responses to a aTIV or aTIV-modified formulations, at 7 days and 6 months post-vaccination.
Time frame: Day 8 and 181 post-vaccination
HI and MN (GMR) 7 days, 21 days, and 6 months post-vaccination.
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Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant
Time frame: Day 1, 8, 22, and 181 post-vaccination
Percentage of subjects with HI titers ≥1:40, ≥1:110, ≥1:160, and ≥1:330 7 days, 21 days, and 6 months post-vaccination.
To compare antibody responses in subjects receiving aTIV-modified formulations in a single intramuscular injection (in one deltoid) to two intramuscular injections (one in each deltoid) at 7 days, 21 days, and 6 months post-vaccination.
Time frame: Day 8, 22, and 181 post-vaccination