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
This study is a randomized, double-blind Phase 1 study of FluMist vs. placebo in mild to
moderately immunocompromised children 5 to 17 years of age with cancer. The primary
objective of this study is to describe the safety of FluMist compared with placebo in mild
to moderately immunocompromised children with cancer. The secondary objectives of this study
are to describe the immune responses following vaccination with FluMist and to determine the
incidence and duration of viral replication following vaccination with FluMist.
The standard 0.5 mL dose of vaccine or placebo was administered intranasally. Patients were
evaluated at four visits scheduled between days 3-5, days 7-10, days 14-28, and days 35-42
for viral shedding via nasal swabs. Safety outcomes were collected at study clinic visits or
by telephone contact through 42 days post dose. Serious adverse events and significant new
medical conditions were collected through 180 days after receipt of investigational product.
Immune responses were measured by detection of influenza-specific antibodies as measured by
the standard hemagglutination inhibition (HAI) assay. Influenza-specific serum antibody
isotype levels were determined and nasal swab specimens were analyzed for the expression of
influenza-specific immunoglobulin A (IgA). Serum was analyzed for its ability to neutralize
viral particles from infecting Madin-Darby canine kidney cells (microneutralization).
Baseline immunosuppression as measured by expression of T- and B-lymphocyte subsets was
compared to immunosuppression at time points after vaccination. The duration of viral
replication and the titers of live-attenuated influenza virus shed was evaluated from nasal
swab specimens collected at scheduled time points after administration of FluMist.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Number of Participants Who Had Reactogenicity Events (REs)
Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. For the participants enrolled in this study REs include fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.
0-42 days after study vaccination
Raburn Mallory, MD
United States: Food and Drug Administration
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of Rochester School of Medicine & Dentistry||Rochester, New York 14642|
|Stony Brook University Medical Center||Stony Brook, New York 11794|
|St. Jude's Children's Research Hospital||Memphis, Tennessee 38105|
|Children's Hospital Regional Medical Center||Seattle, Washington 98105|