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About
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.
Full description
This is a Phase I study of up to 100 healthy children, ages 6 months to 10 years of age, who will receive either Flumist® live, attenuated influenza virus vaccine, quadrivalent (LAIV4) or the current Fluzone® inactivated influenza vaccine, quadrivalent (IIV4). The volunteers will be enrolled into one of 3 Groups. Volunteers will return each year until 2018-2019 for annual flu immunizations and study visits. Questionnaires will be administered annually to record demographic characteristics, vaccination history, exposure to animals, day care and medically attended illness. There are no exclusions for gender, ethnicity or race.
Volunteers in the Non-twin Flu/MMRV naive group will also receive the measles, mumps, rubella and varicella (MMRV) vaccine at approximately 12-15 months of age (to be administered by the volunteers' personal pediatrician, not as a study vaccine). They will then come for a study visit to collect blood 60 days later.
Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.
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Interventional model
Masking
80 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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