A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

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Detailed Description

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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

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Low dose flu vaccine delivered intradermally using microneedles

Group Type EXPERIMENTAL

Flu Vaccine (FLUARIX®)

Intervention Type BIOLOGICAL

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

2

Medium dose flu vaccine delivered intradermally using microneedles

Group Type EXPERIMENTAL

Flu Vaccine (FLUARIX®)

Intervention Type BIOLOGICAL

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

3

Standard dose flu vaccine delivered intramuscularly with a regular needle

Group Type ACTIVE_COMPARATOR

Flu Vaccine (FLUARIX®)

Intervention Type BIOLOGICAL

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

Interventions

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Flu Vaccine (FLUARIX®)

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Signed an Informed Consent
* No previous immune-related disease

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes