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Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01039623
First received: December 24, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.


Condition Intervention
Healthy
 Biological: Pandemrix® (H1N1 pandemic influenza)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • antibody levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Pandemrix® (H1N1 pandemic influenza)
    vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant.
Detailed Description:

Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-64
  • Both genders
  • Healthy

Exclusion Criteria:

  • Under 18 or above 64
  • Not healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039623

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD     972-2-6776095     lhadas@hadassah.org.il    
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. Engelhard Dan, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01039623     History of Changes
Other Study ID Numbers: Vaccine-HMO-CTIL
Study First Received: December 24, 2009
Last Updated: December 24, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Healthy volunteers

ClinicalTrials.gov processed this record on May 16, 2013