Influenza, Human Clinical Trial
Official title:
A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.
Influenza vaccination is the primary method for preventing influenza and its severe
complications. Previous clinical studies demonstrated that delivery of vaccines
intradermally (into the skin) can achieve good efficacy even with lower doses of the
vaccine.
Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared
to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular
needle.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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