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Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01008683
Collaborator
(none)
300
Enrollment
1
Location
8
Duration (Months)
37.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

In these patients the investigators will measure the specific antibody production.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.

    In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Time Perspective:
    Prospective
    Official Title:
    Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
    Study Start Date :
    Nov 1, 2009
    Anticipated Primary Completion Date :
    Apr 1, 2010
    Anticipated Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Stem cell and and heart transplant patients

    Stem cell and and heart transplant patients

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
      Exclusion Criteria:
      • Patients with unstable grafts.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hadassah Medical Organization Jerusalem Israel

      Sponsors and Collaborators

      • Hadassah Medical Organization

      Investigators

      • Principal Investigator: Dan Engelhard, Hadassah

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01008683
      Other Study ID Numbers:
      • engelhard-HMO-CTIL
      First Posted:
      Nov 6, 2009
      Last Update Posted:
      Nov 6, 2009
      Last Verified:
      Nov 1, 2009
      Keywords provided by , ,
      Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations
      Additional relevant MeSH terms:
      Influenza, Human

      Study Results

      No Results Posted as of Nov 6, 2009