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

NanoPass Technologies

Status: Completed

Conditions: Influenza, Human

Treatments: Biological: Flu Vaccine (FLUARIX®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558649

EudraCT number 2007-001160-77

NP39

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

1

Experimental group

Description:

Low dose flu vaccine delivered intradermally using microneedles

Treatment:

Biological: Flu Vaccine (FLUARIX®)

2

Experimental group

Description:

Medium dose flu vaccine delivered intradermally using microneedles

Treatment:

Biological: Flu Vaccine (FLUARIX®)

3

Active Comparator group

Description:

Standard dose flu vaccine delivered intramuscularly with a regular needle

Treatment:

Biological: Flu Vaccine (FLUARIX®)