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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
80
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
Stanford University
Stanford, California, United States
Frequency of antigen-specific T memory phenotype cells (TMP)
The percentage of cells with the various antigen-specific T memory phenotypes will be determined.
Time frame: Day 0 to Day 60
T cell receptor (TCR) repertoire analysis deep phenotyping by mass cytometry (CyTOF)
The TCR repertoire encompasses the different sub-types of T-cell receptors of the immune system.
Time frame: Day 0 to Day 60
Deep phenotyping by mass cytometry (CyTOF)
Deep phenotyping is the analysis of phenotypic abnormalities of the individual components of the phenotype.
Time frame: Day 0 to Day 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.