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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00558649

Acronym

NANOVAX

Enrollment

180

Registered

2007-11-15

Start date

2007-05-31

Completion date

2007-12-31

Last updated

2013-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

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.

Interventions

BIOLOGICALFlu Vaccine (FLUARIX®)

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026