NCT00419224

Brief Summary

The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
Last Updated

January 11, 2007

Status Verified

January 1, 2007

First QC Date

January 5, 2007

Last Update Submit

January 9, 2007

Conditions

Influenza

Keywords

Peripheral blood stem cell transplantationNon-myeloabalativeInfluenza vaccinationHumoral immune responseImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?

Interventions

inactivated split-virus influenza vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years.
  • Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination.

You may not qualify if:

  • Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy.
  • Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Sherif B Mossad, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

October 1, 2002

Study Completion

April 1, 2003

Last Updated

January 11, 2007

Record last verified: 2007-01

Locations

US(1)