At a glance
ClinicalIndex Comparison Record- ✓Age 5 through 17 years (not yet 18th birthday)
- ✓Currently receiving chemotherapy and/or radiation therapy for cancer, or received chemotherapy within past 12 weeks
- ✓If solid tumor: stable disease, partial response, or complete response; if hematologic malignancy: in remission
- ✓Estimated life expectancy >1 year
- ✕History of hypersensitivity to any component of FluMist, including egg or egg products, or monosodium glutamate
- ✕History of hypersensitivity to gentamicin
- ✕History of asthma
- ✕Guillain-Barré syndrome history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age
In Brief
A Phase 1 clinical trial evaluating FluMist and Placebo for Cancer. Completed, enrolled 20 participants across 5 sites.
Detailed Summary
The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose.
Study Details
Timeline
Interventions
The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like. brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.
Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).