This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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. The completion date has passed and the status has not been verified in more than two years.
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
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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • antibody levels [ Time Frame: one year ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Hadassah Medical Organization:
Healthy volunteers

ClinicalTrials.gov processed this record on August 16, 2017