The purpose of this study is to determine if the administration of flu vaccine using Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory tests of immune response.
Primary: To evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (IM) injection versus needle and syringe IM injection as determined with serum hemagglutination inhibition (HAI) reciprocal titers in healthy adults between 18-64 years. Secondary: To compare tolerability and safety of the vaccine in the same population based on specifically solicited local and systemic reactions occurring through 7 days post-immunization and adverse events spontaneously reported through approximately 28 days post immunization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
985
Influenza Vaccine
Optimal Research LLC
Huntsville, Alabama, United States
Optimal Research, LLC
San Diego, California, United States
Optimal Research, LLC
Melbourne, Florida, United States
Optimal Research, LLC
Peoria, Illinois, United States
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Time frame: 28 Days
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Time frame: 28 Days
Percentage of Subjects With Immediate Complaints
The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was given. The data will be reported as "immediate complaints" and presumed to be related to the test article. Any other symptom experienced at 30 minutes will be recorded as an adverse event.
Time frame: Day 0
Percentage of Subjects With Solicited Local or Systemic Adverse Events
vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.
Time frame: 7 Days
Percentage of Subjects With Spontaneously Reported Adverse Events
Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Optimal Reserach, LLC
Mishawaka, Indiana, United States
Optimal Research, LLC
Rockville, Maryland, United States
Time frame: 28 days