This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.
This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either VAX2012Q or Fluzone. Four hundred fifty (450) subjects will be randomized 1:1:1 ratio of either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine. Randomization will be stratified for age (18-49 and 50-64 years). Subjects will be stratified by two age groups (18-49 and 50-64) and randomized in a 1:1:1 ratio to either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine. 25-35% of the total study population will be recruited into the 50-64 age group. The primary objective of the study is to evaluate the seroconversion rates at Day 21 for both dose levels of VAX2012Q.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
450
Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages
Fluzone Quadrivalent (Influenza Vaccine)
Optimal Research
Huntsville, Alabama, United States
Optimal Research
San Diego, California, United States
Optimal Research
Melbourne, Florida, United States
Optimal Research
Peoria, Illinois, United States
Seroconversion rates to the 4 components of VAX2012Q
Immune response to the vaccine will be measured in sera by the hemagglutination inhibition (HAI) assay.
Time frame: Through day 21
Safety following vaccination assessed by Adverse events (AEs)
vital signs, laboratory test results and analgesic and antipyretic use to treat symptoms emerging post vaccination will be collected.
Time frame: Through day 21
Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent
Immune responses to the vaccines will be measured in sera by HAI assay.
Time frame: Through day 21
C-reactive protein levels
Measure C-reactive protein levels.
Time frame: Through day 7
Long term safety following vaccination assessed by Clinically significant AEs
including Serious Adverse Events, Adverse Events of Special Interest and new onset chronic diseases, will be collected.
Time frame: After Day 21 through one year
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Optimal Research
Mishawaka, Indiana, United States
Optimal Research
Rockville, Maryland, United States