NCT00906750

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	FluMist is a live attenuated intranasal influenza vaccine
BIOLOGICAL	Inactivated influenza vaccine	Inactivated influenza vaccine

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-05-21
• Last updated: 2011-10-13

Locations

1 site across 1 country: United States