A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
Not Applicable
Completed
- Conditions
- Influenza, Human
- Interventions
- Biological: Flu Vaccine (FLUARIX®)
- Registration Number
- NCT00558649
- Lead Sponsor
- NanoPass Technologies Ltd
- Brief Summary
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Flu Vaccine (FLUARIX®) Medium dose flu vaccine delivered intradermally using microneedles 3 Flu Vaccine (FLUARIX®) Standard dose flu vaccine delivered intramuscularly with a regular needle 1 Flu Vaccine (FLUARIX®) Low dose flu vaccine delivered intradermally using microneedles
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method