Healthy Clinical Trial
Official title:
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.
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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