A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
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.
Low dose flu vaccine delivered intradermally using microneedles
Medium dose flu vaccine delivered intradermally using microneedles
Standard dose flu vaccine delivered intramuscularly with a regular needle
Inclusion Criteria: Signed an Informed Consent No previous immune-related disease Important Exclusion Criteria: Significant illness within the previous 4 weeks Subjects who have received an influenza vaccine within the previous 6 months An active viral diseases Pregnant or nursing women Any known contraindication to the study vaccine or vaccine ingredients