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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoPass Technologies Ltd
ClinicalTrials.gov Identifier:
NCT00558649
First received: May 27, 2007
Last updated: May 8, 2013
Last verified: November 2007
History of Changes
  Purpose

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


Condition Intervention
Influenza, Human
 Biological: Flu Vaccine (FLUARIX®)

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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by NanoPass Technologies Ltd:

Enrollment: 180
Study Start Date: May 2007
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose flu vaccine delivered intradermally using microneedles
 Biological: Flu Vaccine (FLUARIX®)
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
Experimental: 2
Medium dose flu vaccine delivered intradermally using microneedles
 Biological: Flu Vaccine (FLUARIX®)
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
Active Comparator: 3
Standard dose flu vaccine delivered intramuscularly with a regular needle
 Biological: Flu Vaccine (FLUARIX®)
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558649

Sponsors and Collaborators
NanoPass Technologies Ltd
Investigators
Principal Investigator: Pierre Van Damme, MD, PhD Center for the Evaluation of Vaccination, University of Antwerp
  More Information

No publications provided

Responsible Party: NanoPass Technologies Ltd
ClinicalTrials.gov Identifier: NCT00558649     History of Changes
Other Study ID Numbers: NP39, EudraCT number 2007-001160-77
Study First Received: May 27, 2007
Last Updated: May 8, 2013
Health Authority: Belgium: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013