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NCT00558649 Clinical Trial

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

Influenza, Human Clinical Trial

— NANOVAX  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00558649
Other study ID # NP39
Secondary ID EudraCT number 2
Status Completed
Phase N/A
First received May 27, 2007
Last updated May 8, 2013
Start date May 2007
Est. completion date December 2007

Study information
Verified date November 2007
Source NanoPass Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Flu Vaccine (FLUARIX®)
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NanoPass Technologies Ltd
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