Trial | NCT00558649  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluarix ...

  • Study Participants

    180
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.
Study Started
May 31
2007
Primary Completion
Sep 30
2007
Study Completion
Dec 31
2007
Last Update
May 10
2013
Estimate

Biological Flu Vaccine (FLUARIX®)

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

1 Experimental

Low dose flu vaccine delivered intradermally using microneedles

2 Experimental

Medium dose flu vaccine delivered intradermally using microneedles

3 Active Comparator

Standard dose flu vaccine delivered intramuscularly with a regular needle

Criteria 

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
No Results Posted