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

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ClinicalTrials.gov Identifier: NCT00558649
Recruitment Status : Completed
First Posted : November 15, 2007
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
NanoPass Technologies Ltd

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

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: Flu Vaccine (FLUARIX®) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : May 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558649


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

Responsible Party: NanoPass Technologies Ltd
ClinicalTrials.gov Identifier: NCT00558649     History of Changes
Other Study ID Numbers: NP39
EudraCT number 2007-001160-77
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: November 2007

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs