NCT00906750

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Oct 2008

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, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

2.7 years

First QC Date

January 5, 2009

Last Update Submit

October 12, 2011

Conditions

Cancer

Keywords

FLuMISTInactivated influenza vaccineStudy of FluMist versus inactivated influenza vaccine in children with cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Immunization response

    10/31/2010

  • Flumist safety

    2 years

  • Viral Replication

    1 year

Study Arms (2)

1

EXPERIMENTAL
Biological: FluMist

2

ACTIVE COMPARATOR
Biological: Inactivated influenza vaccine

Interventions

FluMistBIOLOGICAL

FluMist is a live attenuated intranasal influenza vaccine

1
Inactivated influenza vaccineBIOLOGICAL

Inactivated influenza vaccine

2

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Carr S, Allison KJ, Van De Velde LA, Zhang K, English EY, Iverson A, Daw NC, Howard SC, Navid F, Rodriguez-Galindo C, Yang J, Adderson EE, McCullers JA, Flynn PM. Safety and immunogenicity of live attenuated and inactivated influenza vaccines in children with cancer. J Infect Dis. 2011 Nov 15;204(10):1475-82. doi: 10.1093/infdis/jir561. Epub 2011 Sep 23.

    PMID: 21949042DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsInfluenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Silvana Carr, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

May 21, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

US(1)