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

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ClinicalTrials.gov Identifier: NCT01008683
Recruitment Status : Unknown
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

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
H1N1 Influenza

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 Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
Study Start Date : November 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Stem cell and and heart transplant patients
Stem cell and and heart transplant patients




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
Criteria

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.

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): NCT01008683


Contacts
Contact: Hadas Lemberg lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Dan Engelhard       engelhard@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Dan Engelhard Hadassah

Responsible Party: Dan Engelhard, HMO
ClinicalTrials.gov Identifier: NCT01008683     History of Changes
Other Study ID Numbers: engelhard-HMO-CTIL
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009

Keywords provided by Hadassah Medical Organization:
Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations

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