Influenza, Healthy
Conditions
Keywords
Inactivated, influenza vaccine quadrivalent, Live, attenuated influenza vaccine quadrivalent, Young children, Identical twins
Brief summary
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.
Detailed 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.
Interventions
BIOLOGICALFluzone®
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.
BIOLOGICALFluMist®
FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy non-twins 6 months - 10 years old, or 2-5 year old identical (MZ) twins. 2. Willing to complete the informed consent process (including assent for minors 7 years old and above). 3. Availability for follow-up for the planned duration of the study - annually until 2018-2019 influenza vaccination season 4. Acceptable medical history by review of inclusion/
Exclusion criteria
and vital signs. 5. Non-twin flu/MMRV naive group: Willing to have primary care physician immunize child with the MMRV vaccine and return for a study visit approximately 60 days later.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of antigen-specific T memory phenotype cells (TMP) | Day 0 to Day 60 | The percentage of cells with the various antigen-specific T memory phenotypes will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T cell receptor (TCR) repertoire analysis deep phenotyping by mass cytometry (CyTOF) | Day 0 to Day 60 | The TCR repertoire encompasses the different sub-types of T-cell receptors of the immune system. |
| Deep phenotyping by mass cytometry (CyTOF) | Day 0 to Day 60 | Deep phenotyping is the analysis of phenotypic abnormalities of the individual components of the phenotype. |
Countries
United States
Outcome results
None listed