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NCT01008683 Clinical Trial

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

H1N1 Influenza Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01008683
Other study ID # engelhard-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received November 5, 2009
Last updated November 5, 2009
Start date November 2009
Est. completion date July 2010

Study information
Verified date November 2009
Source Hadassah Medical Organization
Contact Hadas Lemberg
Email lhadas@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date July 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 80 Years
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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