A Study of a Live Intranasal Influenza Vaccine in Children With Cancer

Cancer Clinical Trial

— FMRESP  

Official title:

A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906750
• Other study ID #: FMRESP
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2009
• Last updated: October 12, 2011
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: October 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

Description:

The secondary objectives of this study are to:

1. Describe the safety of FluMist and inactivated influenza vaccine.

2. Describe the incidence and duration of viral replication following immunization with FluMist.

3. To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

• Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study

• Participant or participants parent/legal guardian available by telephone during the course of the study;

• Written informed consent (and assent, if applicable) obtained

• Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;

• If the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent;

• Estimated life expectancy of > 1 year

Exclusion Criteria:

• History of hypersensitivity to any component of FluMist or TIV, including egg or egg products, gelatin, or monosodium glutamate;

• History of hypersensitivity to gentamicin;

• Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment

• History of Guillain-Barre´ syndrome;

• History of asthma;

• Female who is breastfeeding or lactating;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• FluMist
FluMist is a live attenuated intranasal influenza vaccine
• Inactivated influenza vaccine
Inactivated influenza vaccine

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer		6 months	Yes
Secondary	Immunization response	To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).	10/31/2010	No
Secondary	Flumist safety	Describe the safety of FluMist and inactivated influenza vaccine.	2 years	Yes
Secondary	Viral Replication	Describe the incidence and duration of viral replication following immunization with FluMist.	1 year	No

External Links

•   St. Jude Children's Research Hospital