Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers

Not Applicable

Terminated

• Conditions: Chronic Myeloproliferative Disorders; Viral Infection; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Brain and Central Nervous System Tumors; Leukemia; Lymphoproliferative Disorder; Nonmalignant Neoplasm

• Registration Number: NCT00952185
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant.

PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers.

Detailed Description

OBJECTIVES:

* To examine the incidence rate of influenza infection over two flu seasons in patients who have undergone hematopoietic stem cell transplantation at the City of Hope National Medical Center.

* To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.

* To examine and compare the incidence rate of influenza in healthy volunteers to the incidence rate in these patients.

OUTLINE: Beginning approximately 2 weeks after vaccination or the onset of flu season, patients and healthy participants undergo nasopharyngeal washes every 14-17 days (2-10 washes) during the months of November-March of the 2008-2009 and 2009-2010 flu seasons. Samples are analyzed by direct fluorescent antibodies.

Patients and participants complete case report forms detailing flu-like symptoms experienced in the 2 weeks before sample collection.

PROJECTED ACCRUAL: A total of 150 patients and 75 healthy volunteers will be accrued for this study.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of influenza infection in patients and healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Vaccine protection
Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States