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

NCT ID: NCT00952185

Last Updated: 2015-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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cytology specimen collection procedure

Intervention Type OTHER

fluorescent antibody technique

Intervention Type OTHER

assessment of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS:

* Life expectancy \> 9 months

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aprille Seidel, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-08121

Identifier Type: -

Identifier Source: secondary_id

08121

Identifier Type: -

Identifier Source: org_study_id

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