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Trial record 4 of 28 for:    pandemrix

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

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ClinicalTrials.gov Identifier: NCT01039623
Recruitment Status : Unknown
Verified December 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 25, 2009
Last Update Posted : December 25, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Biological: Pandemrix® (H1N1 pandemic influenza) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : April 2012

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.


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


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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

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): 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

Responsible Party: Dr. Engelhard Dan, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01039623     History of Changes
Other Study ID Numbers: Vaccine-HMO-CTIL
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: December 25, 2009
Last Verified: December 2009

Keywords provided by Hadassah Medical Organization:
Healthy volunteers