Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Influenza
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 2 years and 49 years
Gender
Both males and females

Description

This is a Phase IV study of licensed influenza vaccines with up to 50 male and female volunteers, 2-49 years of age. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA) or other non-infectious indication as part of their routine medical care. The investig...

This is a Phase IV study of licensed influenza vaccines with up to 50 male and female volunteers, 2-49 years of age. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA) or other non-infectious indication as part of their routine medical care. The investigator intends to collect blood and lymphoid tissues routinely discarded during surgery from adults and children after routine seasonal live attenuated influenza vaccination (LAIV) to determine how immune memory develops at the actual site of infection, and how immunization may alter this process. The first research study visit will take place approximately 3-14 days prior to the scheduled date of tonsillectomy surgery. During this visit, 20 mL blood sample will be obtained and participants will receive FluMist (intranasal, quadrivalent, live-attenuated influenza vaccine). This is one of the routinely available and recommended vaccines for the age groups included in this study. The second study visit will take place on the same day of the scheduled surgery for the tonsillectomy. Another blood sample (maximum volume of 20 mL) will be collected along with the discarded tonsillar tissue. Blood and tissues will be sent to the lab.

Tracking Information

NCT #
NCT03884296
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Not Provided