Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age



Status:Completed
Conditions:Healthy Studies, Influenza
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:12/13/2018
Start Date:May 8, 2017
End Date:September 29, 2017

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A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age

This study is being conducted to compare the immunogenicity, safety, and viral shedding of a
new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the
2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine
in the 2015-2016 influenza season.

This randomized, double-blind, multi-center study will enroll approximately 200 children 24
to less than (<) 48 months of age. Participants will be randomized in a 1:1:1 ratio to
receive two doses of either FluMist quadrivalent 2017-2018, FluMist quadrivalent 2015-2016
formulation, or FluMist trivalent 2015-2016 formulation.

Participants will be screened within 30 days prior to randomization. Randomization will be
stratified according to whether the participant ever received prior influenza vaccination.
Approximately 50% of the participants will not have been previously vaccinated. All
participants will receive two doses of investigational product on Study Days 1 and 28, and
followed for a 28-day follow-up period after each dose. Blood and nasal samples will be
collected and safety evaluations perfomed.

The duration of participants participation is approximately 2 to 3 months. The study will be
conducted during the influenza "off-season" in the US. After completion of the study all
participants will be offered and strongly encouraged to receive an inactivated influenza
vaccine approved for use in the US for the 2017-2018 influenza season.

Key Inclusion Criteria:

- Age 24 months to < 48 months of age

- Healthy by medical history and physical examination or presence of stable underlying
chronic medical condition for which hospitalization has not been required in the
previous year

Key Exclusion Criteria:

- History of allergic disease or reactions likely to be exacerbated by any component of
the investigational product

- Acute illness or evidence of significant active infection (including fever >= 100.4
degrees Fahrenheit (38.0 degrees Celsius) at randomization

- History of asthma or history of recurrent wheezing

- Any known immunosuppressive condition or immune deficiency disease

- Current or expected receipt of immunosuppressive medications within a 28 day window
around vaccination

- Use of aspirin or salicylate-containing medications within 28 days prior to
randomization or expected receipt thru 28 days after vaccination

- Use of antiviral agents with activity against influenza viruses within 48 hours prior
to first dose of investigational product or anticipated use of such agents through the
end of the study follow-up period

- Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or
planned receipt of non-study seasonal influenza vaccine prior to 28 days after last
vaccination

- Receipt of immunoglobulin or blood products within 90 days before randomization into
the study or expected receipt during study participation

- Known or suspected mitochondrial encephalomyopathy

- History of Guillian-Barre syndrome

- Administration of intranasal medications within 10 days prior to randomization, for
expected receipt through 10 days after administration of each dose of investigational
product
We found this trial at
12
sites
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Norfolk, NE
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Bardstown, KY
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Binghamton, NY
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Dakota Dunes, South Dakota 57049
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Dakota Dunes, SD
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Fort Worth, TX
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Omaha, NE
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Saint Louis, MO
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Salt Lake City, UT
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San Angelo, TX
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Savannah, GA
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Tomball, TX
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West Jordan, UT
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