Trials / Completed
CompletedNCT00558649
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- NanoPass Technologies Ltd · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Flu Vaccine (FLUARIX®) | Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2007-09-01
- Completion
- 2007-12-01
- First posted
- 2007-11-15
- Last updated
- 2013-05-10
Source: ClinicalTrials.gov record NCT00558649. Inclusion in this directory is not an endorsement.