NCT01008683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 6, 2009

Status Verified

November 1, 2009

Enrollment Period

5 months

First QC Date

November 5, 2009

Last Update Submit

November 5, 2009

Conditions

H1N1 Influenza

Keywords

Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations

Study Arms (1)

Stem cell and and heart transplant patients

Stem cell and and heart transplant patients

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with unstable grafts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Dan Engelhard

    Hadassah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Lemberg

CONTACT

lhadas@hadassah.org.il

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

November 6, 2009

Record last verified: 2009-11

Locations

IL(1)